Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-26 @ 1:41 AM
Study NCT ID:
NCT03956433
Status:
COMPLETED
Last Update Posted:
2019-05-20
First Post:
2018-01-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Bioactive Enriched Food on Markers of Metabolic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004281', 'term': 'Docosahexaenoic Acids'}, {'id': 'D047071', 'term': 'beta-Glucans'}, {'id': 'D000872', 'term': 'Anthocyanins'}], 'ancestors': [{'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}, {'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D005419', 'term': 'Flavonoids'}, {'id': 'D002867', 'term': 'Chromones'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D010860', 'term': 'Pigments, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double-blind'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Five treatment groups, no placebo.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2015-07-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-17', 'studyFirstSubmitDate': '2018-01-26', 'studyFirstSubmitQcDate': '2019-05-17', 'lastUpdatePostDateStruct': {'date': '2019-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-07-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fasting triglyceride concentration', 'timeFrame': 'Day 1 to Day 28', 'description': 'Change in fasting triglyceride concentration between baseline and endpoint'}, {'measure': 'Fasting HDL concentration', 'timeFrame': 'Day 1 to Day 28', 'description': 'Change in fasting HDL concentration between baseline and endpoint'}], 'secondaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': 'Day 1 to day 28', 'description': 'Change in systolic and/or diastolic blood pressure between baseline and endpoint'}, {'measure': 'Fasting blood glucose concentration', 'timeFrame': 'Day 1 to day 28', 'description': 'Change in fasting blood glucose concentration between baseline and endpoint'}, {'measure': 'Waist circumference', 'timeFrame': 'Day 1 to day 28', 'description': 'Change in waist circumference between baseline and endpoint'}, {'measure': 'Body mass index', 'timeFrame': 'Day 1 to day 28', 'description': 'Change in body mass index between baseline and endpoint'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'This pilot study will investigate the enrichment type, in pancakes, most effective at improving markers of metabolic syndrome. Ready-made pancakes enriched with either docosahexaenoic acid (DHA), beta-glucan (BG) or anthocyanins (AC), alone or in combination of DHA+BG or DHA+AC, will be consumed for 4 weeks.', 'detailedDescription': 'There is scientific evidence to support health claims that docosahexaenoic acid (DHA), an omega-3 fatty acid, and beta-glucan (BG), a soluble plant fibre, can help to maintain healthy cholesterol and triglyceride levels. It is also reported that anthocyanins (AC), colour pigments found in many dietary plants, can lower concentrations of low-density lipoprotein (LDL) cholesterol and increase high-density lipoprotein (HDL) cholesterol in dyslipidemic adults. Research studies often focus on bioactives administered as supplements, this study will also investigate the effectiveness of the food matrix. The project addresses the exploitation of bioactive compounds extracted from natural food sources that when added as ingredients to foods and consumed within the common diet, could significantly benefit human health and wellbeing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nSubjects will be eligible to the pilot study if they present with two to four of the criteria for metabolic syndrome (MetS), at least one of them being alteration of fasting triglycerides or HDL-C cholesterol. MetS is defined when three of the following criteria are met:\n\n* elevated waist circumference (men ≥ 102 cm; women ≥ 88 cm)\n* elevated fasting triglycerides (≥ 150 mg/dL)\n* reduced fasting HDL-cholesterol (men ≤ 40 mg/dL; women ≤ 50 mg/dL)\n* elevated blood pressure (systolic ≥ 130 mmHg and/or diastolic ≥ 85 mmHg) or hypotensive treatment\n* elevated fasting glucose (≥ 110 mg/dL)\n\nExclusion Criteria:\n\nParticipants are excluded if three or more clinical criteria for metabolic syndrome are met. Additionally, major exclusion criteria are:\n\n* regular drug therapy with impact on serum lipids;\n* diabetes (fasting glucose \\> 1.26 g/L, or anti-diabetic treatment);\n* recent history of cancer or cancer treatment (less than 2 years);\n* active or recently diagnosed intestinal malabsorption or disorders associated with malabsorption: Crohn's disease, short bowel syndrome, Pancreatic insufficiency , cystic fibrosis, Tropical Sprue, whipple's disease, chronic pancreatitis, gastrojejunostomy, surgical treatments for obesity, cholestasis, biliary atresia, parasite infections, HIV/AIDS\n* familial dyslipidemia;\n* use of medication known to cause malabsorption: tetracycline, cholestyramine, thiazide diuretics, aluminum/magnesium hydroxide, colchicine, neomycin, methotrexate, methyldopa, and allopurinol, and laxatives\n* illegal drug use, chronic alcoholism or active smoking;\n* intensive physical exercise (≥ 5 hour/week);\n* consumption of nutritional supplements containing DHA, BG or AC;\n* history of allergy or intolerance to any components used in BEFs, celiac disease, lactose intolerance, allergy to milk or egg proteins;\n* institutionalised patients, those who lack autonomy to consent or are unable to meet all examinations;\n* women who are pregnant, lactating or actively trying to conceive;\n* participation in other clinical trials that may impact on outcome;\n* subjects deprived of their liberty by judicial or administrative decision."}, 'identificationModule': {'nctId': 'NCT03956433', 'acronym': 'PATHWAY-27', 'briefTitle': 'Effect of Bioactive Enriched Food on Markers of Metabolic Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University of Leeds'}, 'officialTitle': 'Investigation of the Effect of Daily Consumption of Bioactive Enriched Foods (BEFs) on Biochemical and Anthropometric Markers of the Metabolic Syndrome in Human Volunteers (a Pilot Study)', 'orgStudyIdInfo': {'id': 'PW27_Pilot_Protocol_v1.2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Docosahexaenoic Acid enriched pancakes', 'description': 'One portion of pancakes enriched with 250 mg docosahexaenoic acid (DHA) to be consumed daily for 4 weeks.', 'interventionNames': ['Dietary Supplement: Ready-made pancakes enriched with docosahexaenoic acid (DHA)']}, {'type': 'EXPERIMENTAL', 'label': 'Beta-glucan enriched pancakes', 'description': 'One portion of pancakes enriched with 3 g beta-glucan (BG) to be consumed daily for 4 weeks.', 'interventionNames': ['Dietary Supplement: Ready-made pancakes enriched with beta-glucan (BG)']}, {'type': 'EXPERIMENTAL', 'label': 'Anthocyanin enriched pancakes', 'description': 'One portion of pancakes enriched with 320 mg anthocyanins (AC) to be consumed daily for 4 weeks.', 'interventionNames': ['Dietary Supplement: Ready-made pancakes enriched with anthocyanins (AC)']}, {'type': 'EXPERIMENTAL', 'label': 'DHA+BG enriched pancakes', 'description': 'One portion of pancakes enriched with 250 mg docosahexaenoic acid (DHA) plus 3 g beta-glucan (BG) to be consumed daily for 4 weeks.', 'interventionNames': ['Dietary Supplement: Ready-made pancakes enriched with docosahexaenoic acid and beta-glucan (DHA+BG)']}, {'type': 'EXPERIMENTAL', 'label': 'DHA+AC enriched pancakes', 'description': 'One portion of pancakes enriched with 250 mg docosahexaenoic acid (DHA) plus 320 mg anthocyanins (AC) to be consumed daily for 4 weeks.', 'interventionNames': ['Dietary Supplement: Ready-made pancakes enriched with docosahexaenoic acid and anthocyanins (DHA+AC)']}], 'interventions': [{'name': 'Ready-made pancakes enriched with docosahexaenoic acid (DHA)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'One portion of DHA-enriched pancakes will be eaten each day for 4 weeks.', 'armGroupLabels': ['Docosahexaenoic Acid enriched pancakes']}, {'name': 'Ready-made pancakes enriched with beta-glucan (BG)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'One portion of BG-enriched pancakes will be eaten each day for 4 weeks.', 'armGroupLabels': ['Beta-glucan enriched pancakes']}, {'name': 'Ready-made pancakes enriched with anthocyanins (AC)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'One portion of AC-enriched pancakes will be eaten each day for 4 weeks.', 'armGroupLabels': ['Anthocyanin enriched pancakes']}, {'name': 'Ready-made pancakes enriched with docosahexaenoic acid and beta-glucan (DHA+BG)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'One portion of DHA+BG-enriched pancakes will be eaten each day for 4 weeks.', 'armGroupLabels': ['DHA+BG enriched pancakes']}, {'name': 'Ready-made pancakes enriched with docosahexaenoic acid and anthocyanins (DHA+AC)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'One portion of DHA+AC-enriched pancakes will be eaten each day for 4 weeks.', 'armGroupLabels': ['DHA+AC enriched pancakes']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LS2 9JT', 'city': 'Leeds', 'state': 'West Yorkshire', 'country': 'United Kingdom', 'facility': 'University of Leeds', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Leeds', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Leeds Teaching Hospitals NHS Trust', 'class': 'OTHER'}, {'name': 'AdWare Research Ltd.', 'class': 'UNKNOWN'}, {'name': 'University of Bologna', 'class': 'OTHER'}, {'name': 'European Union', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Postdoctoral Research Fellow', 'investigatorFullName': 'Samantha Sutulic', 'investigatorAffiliation': 'University of Leeds'}}}}