Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-31 @ 12:06 PM
Study NCT ID:
NCT03347006
Status:
COMPLETED
Last Update Posted:
2025-05-25
First Post:
2017-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
SPM Regulation by Fish Oil Supplements in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'j.dalli@qmul.ac.uk', 'phone': '+442078828263', 'title': 'Professor Jesmond Dalli', 'organization': 'Queen Mary University of London'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 1 month after the last supplement/placebo dose was administered, an average of 40 days', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo control\n\nSPM Active: Supplement or placebo will be administered orally between 9 am to 9:30 am.\n\n* Each participant will give a baseline blood sample then they will be given one of the randomly allocated three doses of fish oil supplement, or a matching placebo in one of 8 study groups \\[this will be on a 1:1:1:1:1:1:1:1 ratio\\]. Blood will be collected again at 2h, 4h, 6h and 24h after supplementation/placebo, 12ml per time interval.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Dose 1', 'description': '1.5 g of omega-3 supplement\n\nSPM Active: Supplement or placebo will be administered orally between 9 am to 9:30 am.\n\n* Each participant will give a baseline blood sample then they will be given one of the randomly allocated three doses of fish oil supplement, or a matching placebo in one of 8 study groups \\[this will be on a 1:1:1:1:1:1:1:1 ratio\\]. Blood will be collected again at 2h, 4h, 6h and 24h after supplementation/placebo, 12ml per time interval.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Dose 2', 'description': '3.0 g of omega-3 supplement\n\nSPM Active: Supplement or placebo will be administered orally between 9 am to 9:30 am.\n\n* Each participant will give a baseline blood sample then they will be given one of the randomly allocated three doses of fish oil supplement, or a matching placebo in one of 8 study groups \\[this will be on a 1:1:1:1:1:1:1:1 ratio\\]. Blood will be collected again at 2h, 4h, 6h and 24h after supplementation/placebo, 12ml per time interval.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Dose 3', 'description': '4.5 g of omega-3 supplement\n\nSPM Active: Supplement or placebo will be administered orally between 9 am to 9:30 am.\n\n* Each participant will give a baseline blood sample then they will be given one of the randomly allocated three doses of fish oil supplement, or a matching placebo in one of 8 study groups \\[this will be on a 1:1:1:1:1:1:1:1 ratio\\]. Blood will be collected again at 2h, 4h, 6h and 24h after supplementation/placebo, 12ml per time interval.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Increase in the Average Peripheral Blood SPM Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo control\n\nSPM Active: Supplement or placebo will be administered orally between 9 am to 9:30 am.\n\n* Each participant will give a baseline blood sample then they will be given one of the randomly allocated three doses of fish oil supplement, or a matching placebo in one of 8 study groups \\[this will be on a 1:1:1:1:1:1:1:1 ratio\\]. Blood will be collected again at 2h, 4h, 6h and 24h after supplementation/placebo, 12ml per time interval.'}, {'id': 'OG001', 'title': 'Dose 1', 'description': '1.5 g of omega-3 supplement\n\nSPM Active: Supplement or placebo will be administered orally between 9 am to 9:30 am.\n\n* Each participant will give a baseline blood sample then they will be given one of the randomly allocated three doses of fish oil supplement, or a matching placebo in one of 8 study groups \\[this will be on a 1:1:1:1:1:1:1:1 ratio\\]. Blood will be collected again at 2h, 4h, 6h and 24h after supplementation/placebo, 12ml per time interval.'}, {'id': 'OG002', 'title': 'Dose 2', 'description': '3.0 g of omega-3 supplement\n\nSPM Active: Supplement or placebo will be administered orally between 9 am to 9:30 am.\n\n* Each participant will give a baseline blood sample then they will be given one of the randomly allocated three doses of fish oil supplement, or a matching placebo in one of 8 study groups \\[this will be on a 1:1:1:1:1:1:1:1 ratio\\]. Blood will be collected again at 2h, 4h, 6h and 24h after supplementation/placebo, 12ml per time interval.'}, {'id': 'OG003', 'title': 'Dose 3', 'description': '4.5 g of omega-3 supplement\n\nSPM Active: Supplement or placebo will be administered orally between 9 am to 9:30 am.\n\n* Each participant will give a baseline blood sample then they will be given one of the randomly allocated three doses of fish oil supplement, or a matching placebo in one of 8 study groups \\[this will be on a 1:1:1:1:1:1:1:1 ratio\\]. Blood will be collected again at 2h, 4h, 6h and 24h after supplementation/placebo, 12ml per time interval.'}], 'classes': [{'categories': [{'measurements': [{'value': '56.49', 'spread': '42.54', 'groupId': 'OG000'}, {'value': '56.91', 'spread': '38.50', 'groupId': 'OG001'}, {'value': '108.8', 'spread': '110.3', 'groupId': 'OG002'}, {'value': '139.7', 'spread': '83.44', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'outcomes will be measured 24h post supplementation and compared with baseline values (0h)', 'description': 'The Primary endpoint of the study will be an increase in peripheral blood SPM levels that will be measured calculated by measuring pre-supplement SPM levels to values measured in plasma after supplementation.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'healthy volunteers'}, {'type': 'SECONDARY', 'title': 'Percentage Change in Omega-3 Fatty Acid Levels From Baseline After 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo control\n\nSPM Active: Supplement or placebo will be administered orally between 9 am to 9:30 am.\n\n* Each participant will give a baseline blood sample then they will be given one of the randomly allocated three doses of fish oil supplement, or a matching placebo in one of 8 study groups \\[this will be on a 1:1:1:1:1:1:1:1 ratio\\]. Blood will be collected again at 2h, 4h, 6h and 24h after supplementation/placebo, 12ml per time interval.'}, {'id': 'OG001', 'title': 'Dose 1', 'description': '1.5 g of omega-3 supplement\n\nSPM Active: Supplement or placebo will be administered orally between 9 am to 9:30 am.\n\n* Each participant will give a baseline blood sample then they will be given one of the randomly allocated three doses of fish oil supplement, or a matching placebo in one of 8 study groups \\[this will be on a 1:1:1:1:1:1:1:1 ratio\\]. Blood will be collected again at 2h, 4h, 6h and 24h after supplementation/placebo, 12ml per time interval.'}, {'id': 'OG002', 'title': 'Dose 2', 'description': '3.0 g of omega-3 supplement\n\nSPM Active: Supplement or placebo will be administered orally between 9 am to 9:30 am.\n\n* Each participant will give a baseline blood sample then they will be given one of the randomly allocated three doses of fish oil supplement, or a matching placebo in one of 8 study groups \\[this will be on a 1:1:1:1:1:1:1:1 ratio\\]. Blood will be collected again at 2h, 4h, 6h and 24h after supplementation/placebo, 12ml per time interval.'}, {'id': 'OG003', 'title': 'Dose 3', 'description': '4.5 g of omega-3 supplement\n\nSPM Active: Supplement or placebo will be administered orally between 9 am to 9:30 am.\n\n* Each participant will give a baseline blood sample then they will be given one of the randomly allocated three doses of fish oil supplement, or a matching placebo in one of 8 study groups \\[this will be on a 1:1:1:1:1:1:1:1 ratio\\]. Blood will be collected again at 2h, 4h, 6h and 24h after supplementation/placebo, 12ml per time interval.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.19', 'spread': '12.90', 'groupId': 'OG000'}, {'value': '70.01', 'spread': '28.31', 'groupId': 'OG001'}, {'value': '22.60', 'spread': '12.26', 'groupId': 'OG002'}, {'value': '89.12', 'spread': '48.61', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Outcomes will be measured 24h post supplementation and compared with baseline values (at 0h)', 'description': 'Measure ability of peripheral blood neutrophils to uptake S. aureus following pre- and post- supplementation. Looking at relationship between amount of omega-3 fatty acids ingested, the increase in the blood levels of these molecules and white blood cell function.', 'unitOfMeasure': 'percent change from baseline', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes in the Expression of Peripheral Blood Neutrophil Activation Markers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo control\n\nSPM Active: Supplement or placebo will be administered orally between 9 am to 9:30 am.\n\n* Each participant will give a baseline blood sample then they will be given one of the randomly allocated three doses of fish oil supplement, or a matching placebo in one of 8 study groups \\[this will be on a 1:1:1:1:1:1:1:1 ratio\\]. Blood will be collected again at 2h, 4h, 6h and 24h after supplementation/placebo, 12ml per time interval.'}, {'id': 'OG001', 'title': 'Dose 1', 'description': '1.5 g of omega-3 supplement\n\nSPM Active: Supplement or placebo will be administered orally between 9 am to 9:30 am.\n\n* Each participant will give a baseline blood sample then they will be given one of the randomly allocated three doses of fish oil supplement, or a matching placebo in one of 8 study groups \\[this will be on a 1:1:1:1:1:1:1:1 ratio\\]. Blood will be collected again at 2h, 4h, 6h and 24h after supplementation/placebo, 12ml per time interval.'}, {'id': 'OG002', 'title': 'Dose 2', 'description': '3.0 g of omega-3 supplement\n\nSPM Active: Supplement or placebo will be administered orally between 9 am to 9:30 am.\n\n* Each participant will give a baseline blood sample then they will be given one of the randomly allocated three doses of fish oil supplement, or a matching placebo in one of 8 study groups \\[this will be on a 1:1:1:1:1:1:1:1 ratio\\]. Blood will be collected again at 2h, 4h, 6h and 24h after supplementation/placebo, 12ml per time interval.'}, {'id': 'OG003', 'title': 'Dose 3', 'description': '4.5 g of omega-3 supplement\n\nSPM Active: Supplement or placebo will be administered orally between 9 am to 9:30 am.\n\n* Each participant will give a baseline blood sample then they will be given one of the randomly allocated three doses of fish oil supplement, or a matching placebo in one of 8 study groups \\[this will be on a 1:1:1:1:1:1:1:1 ratio\\]. Blood will be collected again at 2h, 4h, 6h and 24h after supplementation/placebo, 12ml per time interval.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.97', 'spread': '8.556', 'groupId': 'OG000'}, {'value': '30.90', 'spread': '8.379', 'groupId': 'OG001'}, {'value': '6.723', 'spread': '5.859', 'groupId': 'OG002'}, {'value': '13.93', 'spread': '6.177', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'outcomes measured 24h post supplementation and compared with baseline values (at 0h)', 'description': 'Changes in the expression of protein linked with neutrophil activation, determined by comparing expression levels of this protein in peripheral blood cells pre- and post supplementation.', 'unitOfMeasure': 'percent change from baseline values', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1', 'description': 'Participants will be assigned randomly to this group. They give a baseline blood sample then they will be administered a placebo. Blood will be collected again at 2h, 4h, 6h and 24h after placebo administration, 12ml per time interval. After a minimum interval of 48 hours from the last blood draw, participants will give blood, they will be administered 1.5g of supplement and blood collected at 2h, 4h, 6h and 24h after supplementation, 12ml per time interval. Participants will be asked to return after a minimum of 48 hours from the last blood draw and blood (baseline) will be collected. The participants will be administered a 3 g of marine oils and blood collected after 2h, 4h, 6h and 24h, 12ml per time interval. After a minimum of 48h from the last blood draw participants will donate blood, they will be then given 4.5 g of marine oils and blood drawn 2h, 4h, 6h and 24h after supplementation, 12ml per time interval.'}, {'id': 'FG001', 'title': 'Group 2', 'description': 'Participants will be assigned randomly to this group. They give a baseline blood sample then they will be administered a 1.5g of marine oils. Blood will be collected again at 2h, 4h, 6h and 24h after supplementation, 12ml per time interval. After a minimum interval of 48 hours from the last blood draw, participants will give blood, they will be administered 3 g of supplement and blood collected at 2h, 4h, 6h and 24h after supplementation, 12ml per time interval. Participants will be asked to return after a minimum of 48 hours from the last blood draw and blood (baseline) will be collected. The participants will be administered a 4.5 g of marine oils and blood collected after 2h, 4h, 6h and 24h, 12ml per time interval. After a minimum of 48h from the last blood draw participants will donate blood, they will be then given placebo and blood drawn 2h, 4h, 6h and 24h, 12ml per time interval.'}, {'id': 'FG002', 'title': 'Group 3', 'description': 'Participants will be assigned randomly to this group. They give a baseline blood sample then they will be administered a 3 g of marine oils. Blood will be collected again at 2h, 4h, 6h and 24h after supplementation, 12ml per time interval. After a minimum interval of 48 hours from the last blood draw, participants will give blood, they will be administered 4.5 g of supplement and blood collected at 2h, 4h, 6h and 24h after supplementation, 12ml per time interval. Participants will be asked to return after a minimum of 48 hours from the last blood draw and blood (baseline) will be collected. The participants will be administered a placebo and blood collected after 2h, 4h, 6h and 24h, 12ml per time interval. After a minimum of 48h from the last blood draw participants will donate blood, they will be then given 1.5 g of marine oils and blood drawn 2h, 4h, 6h and 24h, 12ml per time interval.'}, {'id': 'FG003', 'title': 'Group 4', 'description': 'Participants will be assigned randomly to this group. They give a baseline blood sample then they will be administered a 4.5 g of marine oils. Blood will be collected again at 2h, 4h, 6h and 24h after supplementation, 12ml per time interval. After a minimum interval of 48 hours from the last blood draw, participants will give blood, they will be administered placebo and blood collected at 2h, 4h, 6h and 24h later, 12ml per time interval. Participants will be asked to return after a minimum of 48 hours from the last blood draw and blood (baseline) will be collected. The participants will be administered a 1.5 g of marine oils and blood collected after 2h, 4h, 6h and 24h, 12ml per time interval. After a minimum of 48h from the last blood draw participants will donate blood, they will be then given 3 g of marine oils and blood drawn 2h, 4h, 6h and 24h, 12ml per time interval.'}, {'id': 'FG004', 'title': 'Group 5', 'description': 'Participants will be assigned randomly to this group. They give a baseline blood sample then they will be administered 4.5 g of marine oils. Blood will be collected again at 2h, 4h, 6h and 24h after supplementation, 12ml per time interval. After a minimum interval of 48 hours from the last blood draw, participants will give blood, they will be administered 3g of marine oils and blood collected at 2h, 4h, 6h and 24h later, 12ml per time interval. Participants will be asked to return after a minimum of 48 hours from the last blood draw and blood (baseline) will be collected. The participants will be administered a 1.5 g of marine oils and blood collected after 2h, 4h, 6h and 24h, 12ml per time interval. After a minimum of 48h from the last blood draw participants will donate blood, they will be then given placebo and blood drawn 2h, 4h, 6h and 24h, 12ml per time interval.'}, {'id': 'FG005', 'title': 'Group 6', 'description': 'Participants will be assigned randomly to this group. They give a baseline blood sample then they will be administered 3 g of marine oils. Blood will be collected again at 2h, 4h, 6h and 24h after supplementation, 12ml per time interval. After a minimum interval of 48 hours from the last blood draw, participants will give blood, they will be administered 1.5 g of marine oils and blood collected at 2h, 4h, 6h and 24h later, 12ml per time interval. Participants will be asked to return after a minimum of 48 hours from the last blood draw and blood (baseline) will be collected. The participants will be administered a placebo and blood collected after 2h, 4h, 6h and 24h, 12ml per time interval. After a minimum of 48h from the last blood draw participants will donate blood, they will be then given 4.5 g of marine oils and blood drawn 2h, 4h, 6h and 24h, 12ml per time interval.'}, {'id': 'FG006', 'title': 'Group 7', 'description': 'Participants will be assigned randomly to this group. They give a baseline blood sample then they will be administered 1.5 g of marine oils. Blood will be collected again at 2h, 4h, 6h and 24h after supplementation, 12ml per time interval. After a minimum interval of 48 hours from the last blood draw, participants will give blood, they will be administered placebo and blood collected at 2h, 4h, 6h and 24h later, 12ml per time interval. Participants will be asked to return after a minimum of 48 hours from the last blood draw and blood (baseline) will be collected. The participants will be administered a 4.5 g of marine oils and blood collected after 2h, 4h, 6h and 24h, 12ml per time interval. After a minimum of 48h from the last blood draw participants will donate blood, they will be then given 3 g of marine oils and blood drawn 2h, 4h, 6h and 24h, 12ml per time interval.'}, {'id': 'FG007', 'title': 'Group 8', 'description': 'Participants will be assigned randomly to this group. They give a baseline blood sample then they will be administered placebo. Blood will be collected again at 2h, 4h, 6h and 24h later, 12ml per time interval. After a minimum interval of 48 hours from the last blood draw, participants will give blood, they will be administered 4.5 g of marine oils and blood collected at 2h, 4h, 6h and 24h later, 12ml per time interval. Participants will be asked to return after a minimum of 48 hours from the last blood draw and blood (baseline) will be collected. The participants will be administered a 3 g of marine oils and blood collected after 2h, 4h, 6h and 24h, 12ml per time interval. After a minimum of 48h from the last blood draw participants will donate blood, they will be then given 1.5 g of marine oils and blood drawn 2h, 4h, 6h and 24h, 12ml per time interval.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Study Population', 'description': 'Since this is a crossover study all the participants in this study will recieved all the study interventions ie 1.5g, 3g 4.5g of marine oils and placebo. These will be administered in one of 8 sequences which will be determined by assigning the volunteer to one of 8 study groups.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'This was a cross over study to every participant received each of the treatments'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26.41', 'spread': '4.01', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Study had a cross over design so all participants received all treatments', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'This was a cross over study'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Study was a cross over study so all participants received all treatments'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Study had a cross over design so all participants received all treatments', 'unitOfMeasure': 'participants', 'populationDescription': 'Study had a cross over design so all participants received all treatments'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '1.70', 'spread': '0.08', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Study had a cross over design so all participants received all treatments', 'unitOfMeasure': 'meters', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Study had a cross over design so all participants received all treatments'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '68.54', 'spread': '18.16', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Study had a cross over design so all participants received all treatments', 'unitOfMeasure': 'Kg', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Study had a cross over design so all participants received all treatments'}, {'title': 'body mass index', 'classes': [{'categories': [{'measurements': [{'value': '23.45', 'spread': '4.74', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Study had a cross over design so all participants received all treatments', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Study had a cross over design so all participants received all treatments'}, {'title': 'Systolic Blood Pressure', 'classes': [{'categories': [{'measurements': [{'value': '118.2', 'spread': '11.39', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Pulse', 'classes': [{'categories': [{'measurements': [{'value': '65.59', 'spread': '7.64', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'bpm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sodium', 'classes': [{'categories': [{'measurements': [{'value': '140.4', 'spread': '2.59', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Potassium', 'classes': [{'categories': [{'measurements': [{'value': '4.434', 'spread': '0.35', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Chloride ions', 'classes': [{'categories': [{'measurements': [{'value': '102', 'spread': '2.00', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Urea', 'classes': [{'categories': [{'measurements': [{'value': '4.818', 'spread': '1.39', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Creatinine', 'classes': [{'categories': [{'measurements': [{'value': '79.09', 'spread': '12.21', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'umol/L)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Protein', 'classes': [{'categories': [{'measurements': [{'value': '72.27', 'spread': '2.83', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'g/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Albumin (g/L)', 'classes': [{'categories': [{'measurements': [{'value': '46.59', 'spread': '2.52', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'g/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Bilirubin', 'classes': [{'categories': [{'measurements': [{'value': '9.409', 'spread': '4.93', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'µmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'adenosine triphosphate', 'classes': [{'categories': [{'measurements': [{'value': '57.5', 'spread': '11.35', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'U/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Alanine aminotransferase', 'classes': [{'categories': [{'measurements': [{'value': '19', 'spread': '9.20', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'U/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Aspartate Transferase', 'classes': [{'categories': [{'measurements': [{'value': '19', 'spread': '4.22', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'U/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Calcium', 'classes': [{'categories': [{'measurements': [{'value': '2.407', 'spread': '0.09', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mml/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Phosphate (mmol/L)', 'classes': [{'categories': [{'measurements': [{'value': '1.13', 'spread': '0.14', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Urate', 'classes': [{'categories': [{'measurements': [{'value': '284.3', 'spread': '59.13', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'µmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'estimated glomerular filtration rate', 'classes': [{'categories': [{'measurements': [{'value': '78.38', 'spread': '7.87', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ml/min/1.73m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Cholesterol', 'classes': [{'categories': [{'measurements': [{'value': '4.79', 'spread': '0.79', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Triglycerides', 'classes': [{'categories': [{'measurements': [{'value': '0.929', 'spread': '0.30', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'High density lipoprotein', 'classes': [{'categories': [{'measurements': [{'value': '1.765', 'spread': '0.35', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Low density lipoprotein', 'classes': [{'categories': [{'measurements': [{'value': '2.602', 'spread': '0.75', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Cholesterol -HDL ratio', 'classes': [{'categories': [{'measurements': [{'value': '2.825', 'spread': '0.68', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ratio', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'non-HDL Cholesterol', 'classes': [{'categories': [{'measurements': [{'value': '3.025', 'spread': '0.84', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'White blood cell count', 'classes': [{'categories': [{'measurements': [{'value': '6.195', 'spread': '1.46', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cells*10^6/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'platelet counts', 'classes': [{'categories': [{'measurements': [{'value': '258.6', 'spread': '60.69', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cells 10^9 /L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hematocrit', 'classes': [{'categories': [{'measurements': [{'value': '0.428', 'spread': '0.04', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'L/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Red blood cell count', 'classes': [{'categories': [{'measurements': [{'value': '4.789', 'spread': '0.42', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cells 10^12/L', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-04-19', 'size': 1852113, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-10-13T06:54', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double blind placebo controlled'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'SPM Active is the supplement tested in this study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-09', 'studyFirstSubmitDate': '2017-11-15', 'resultsFirstSubmitDate': '2022-03-18', 'studyFirstSubmitQcDate': '2017-11-15', 'lastUpdatePostDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-09', 'studyFirstPostDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Increase in the Average Peripheral Blood SPM Levels', 'timeFrame': 'outcomes will be measured 24h post supplementation and compared with baseline values (0h)', 'description': 'The Primary endpoint of the study will be an increase in peripheral blood SPM levels that will be measured calculated by measuring pre-supplement SPM levels to values measured in plasma after supplementation.'}], 'secondaryOutcomes': [{'measure': 'Percentage Change in Omega-3 Fatty Acid Levels From Baseline After 24 Hours', 'timeFrame': 'Outcomes will be measured 24h post supplementation and compared with baseline values (at 0h)', 'description': 'Measure ability of peripheral blood neutrophils to uptake S. aureus following pre- and post- supplementation. Looking at relationship between amount of omega-3 fatty acids ingested, the increase in the blood levels of these molecules and white blood cell function.'}, {'measure': 'Changes in the Expression of Peripheral Blood Neutrophil Activation Markers', 'timeFrame': 'outcomes measured 24h post supplementation and compared with baseline values (at 0h)', 'description': 'Changes in the expression of protein linked with neutrophil activation, determined by comparing expression levels of this protein in peripheral blood cells pre- and post supplementation.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'referencesModule': {'references': [{'pmid': '31829100', 'type': 'DERIVED', 'citation': 'Souza PR, Marques RM, Gomez EA, Colas RA, De Matteis R, Zak A, Patel M, Collier DJ, Dalli J. Enriched Marine Oil Supplements Increase Peripheral Blood Specialized Pro-Resolving Mediators Concentrations and Reprogram Host Immune Responses: A Randomized Double-Blind Placebo-Controlled Study. Circ Res. 2020 Jan 3;126(1):75-90. doi: 10.1161/CIRCRESAHA.119.315506. Epub 2019 Dec 12.'}]}, 'descriptionModule': {'briefSummary': 'A randomised, double-blind, placebo-controlled study to determine whether fish oil supplementation regulates peripheral levels of specialized pro-resolving mediators and white blood cell responses in healthy volunteers', 'detailedDescription': "Rationale for the study The relationship between omega-3 essential fatty acid supplementation, and specifically fish oil supplementation, and SPM production in humans is very poorly understood. Given that the body produces SPM from omega-3 essential fatty acids to regulate inflammation and also to repair damaged tissues, it is critical to gain further insights on how the body utilizes dietary supplementation of omega-3 fatty acids from fish oils for SPM formation. With the availability of a mass spectrometry based platform developed by the investigators the scientific community is now in a unique position to better understand the biology of fish oil supplementation by monitoring the levels of SPM in plasma. This understanding may in turn shed light into the beneficial actions of omega-3 supplementation. It may also provide new leads for the control of excessive inflammation, as found in chronic inflammatory disorders, via dietary supplementation to exploit the body's own defense systems.\n\nRationale for choice of doses Given that in a study using a different fish oil source and formulation the investigators found that 1 g of essential fatty acids gave a mild but significant increase in plasma SPM levels (25) the investigators chose the lowest dose in the study to be of 1.5g. with the other two doses being within the European Food Safety Authority's Tolerable Upper Intake Level for supplements containing both EPA and DHA. Given that this limit is of 5 g and previous study with both healthy volunteers and patients demonstrated that doses up to 4 g are well tolerated (22-24), the investigators chose the remaining 2 doses to be 3.0 g and 4.5 g. In addition, this supplement was awarded a Generally Recognized as Safe Status (see appendix 1) in the for a dose of up to 5 g. Similar doses of the emulsion from of the fish oil supplement are also being used in an ongoing clinical study in the USA (ClinicalTrials.gov Identifier: NCT02719665) measuring different outcomes to those being investigated in the present study.\n\nAim of research The aim of this research is to investigate whether fish oil supplementation increases the peripheral blood levels of SPM and whether fish oil supplementation also regulates peripheral white blood cell responses (including neutrophils, monocytes and platelets) to inflammatory stimuli.\n\nOriginal hypothesis Given that fish oils are rich in omega-3 essential fatty acids that are precursors in the biosynthesis of SPM the hypothesis underlying the present study is: Fish oil supplementation increase peripheral blood levels of SPM precursors that may be converted to bioactive mediators which in turn will regulate white blood cell responses."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* For participants to be included in the study they will need to meet the following criteria:\n\n 1. Able to provide informed consent\n 2. Men and women between the age of 18 and 45\n 3. Declare not to be taking aspirin, other NSAIDS, other form of medication or omega-3 fatty acid supplements for more than 2 weeks prior to screening and the duration of the participation.\n 4. Willingness to abstain from eating fish for 2 days before each study visit\n 5. Willingness to abstain from alcohol consumption for at least 24h prior to each study visit\n 6. Willingness to abstain from caffeine as directed before and during study\n\nExclusion Criteria:\n\n* 1\\) History of, chronic disorders, cardiovascular disease (e.g., heart disease, stroke), cancer, or diabetes or significant genetically inherited conditions.\n\n 2\\) Pregnancy or breast-feeding. 3) Hypothyroidism in the opinion of the investigator. 4) Liver disease in the opinion of the investigator. 5) Any abnormality or pre-existing disease which, in the opinion of the investigator, might either expose the subject to risk, or influence the validity of the results.\n\n 6\\) Women of childbearing potential not taking adequate methods of contraception 7) Inability to read and write in English 8) Participation in a clinical study of a new chemical entity, biological product or a prescription medicine, or loss of more than 400 mL blood, within the previous 3 months 9) Anyone who is currently smoking or used to smoke 10) Presence or history of drug or alcohol abuse or intake of more than the amount of alcohol in the current guidelines on alcohol consumption'}, 'identificationModule': {'nctId': 'NCT03347006', 'briefTitle': 'SPM Regulation by Fish Oil Supplements in Healthy Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'Queen Mary University of London'}, 'officialTitle': 'Exploratory Double Blind Placebo Controlled Study Investigating the Regulation of Proresolving Mediators and White Blood Cell Responses by Fish Oil Supplements in Healthy Volunteers', 'orgStudyIdInfo': {'id': '011549'}, 'secondaryIdInfos': [{'id': '16/LO/2182', 'type': 'OTHER', 'domain': 'Research ethics council'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo control', 'interventionNames': ['Dietary Supplement: SPM Active']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 1', 'description': '1.5 g of omega-3 supplement', 'interventionNames': ['Dietary Supplement: SPM Active']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 2', 'description': '3.0 g of omega-3 supplement', 'interventionNames': ['Dietary Supplement: SPM Active']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 3', 'description': '4.5 g of omega-3 supplement', 'interventionNames': ['Dietary Supplement: SPM Active']}], 'interventions': [{'name': 'SPM Active', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Supplement or placebo will be administered orally between 9 am to 9:30 am.\n\n* Each participant will give a baseline blood sample then they will be given one of the randomly allocated three doses of fish oil supplement, or a matching placebo in one of 8 study groups \\[this will be on a 1:1:1:1:1:1:1:1 ratio\\]. Blood will be collected again at 2h, 4h, 6h and 24h after supplementation/placebo, 12ml per time interval.', 'armGroupLabels': ['Dose 1', 'Dose 2', 'Dose 3', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'EC1M 6BQ', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Queen Mary University of London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Queen Mary University of London', 'class': 'OTHER'}, 'collaborators': [{'name': 'Metagenics, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}