Ignite Creation Date:
2025-12-26 @ 12:19 PM
Ignite Modification Date:
2026-03-01 @ 5:17 PM
Study NCT ID:
NCT01719900
Status:
COMPLETED
Last Update Posted:
2020-01-21
First Post:
2012-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Pulse Fibre Supplementation on Obesity and the Metabolic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D001836', 'term': 'Body Weight Changes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'reimer@ucalgary.ca', 'phone': '14032208218', 'title': 'Dr. Raylene Reimer', 'organization': 'University of Calgary'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'description': '53 assessed for serious adverse events', 'eventGroups': [{'id': 'EG000', 'title': 'Pulse Fibre', 'description': 'The intervention group will receive a biscuit containing 5g/serving of yellow pea fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.\n\nPulse fibre: Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 0, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'The placebo group will receive a biscuit an isocaloric control biscuit that is similar in taste and texture and without pulse fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.\n\nControl: Control biscuit with no yellow pea hull fibre.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Fat Mass at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pulse Fibre', 'description': 'The intervention group will receive a biscuit containing 5g/serving of yellow pea fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.\n\nPulse fibre: Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.'}, {'id': 'OG001', 'title': 'Control', 'description': 'The placebo group will receive a biscuit an isocaloric control biscuit that is similar in taste and texture and without pulse fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.\n\nControl: Control biscuit with no yellow pea hull fibre.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.74', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '0.42', 'spread': '0.38', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Value at 12 weeks minus value at baseline', 'description': 'Value at 12 weeks minus value at baseline assessed with dual energy x-ray absorptiometry.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'HbA1c at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pulse Fibre', 'description': 'The intervention group will receive a biscuit containing 5g/serving of yellow pea fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.\n\nPulse fibre: Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.'}, {'id': 'OG001', 'title': 'Control', 'description': 'The placebo group will receive a biscuit an isocaloric control biscuit that is similar in taste and texture and without pulse fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.\n\nControl: Control biscuit with no yellow pea hull fibre.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.68', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '5.89', 'spread': '0.11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Assessed via HbA1c', 'unitOfMeasure': '% in blood', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Objective Appetite at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pulse Fibre', 'description': 'The intervention group will receive a biscuit containing 5g/serving of yellow pea fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.\n\nPulse fibre: Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.'}, {'id': 'OG001', 'title': 'Control', 'description': 'The placebo group will receive a biscuit an isocaloric control biscuit that is similar in taste and texture and without pulse fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.\n\nControl: Control biscuit with no yellow pea hull fibre.'}], 'classes': [{'categories': [{'measurements': [{'value': '-16', 'spread': '6', 'groupId': 'OG000'}, {'value': '5', 'spread': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks minus baseline', 'description': 'Value at 12 weeks minus baseline energy intake during weighed lunch buffet.', 'unitOfMeasure': '% of baseline food intake', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Cholesterol Profile at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pulse Fibre', 'description': 'The intervention group will receive a biscuit containing 5g/serving of yellow pea fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.\n\nPulse fibre: Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.'}, {'id': 'OG001', 'title': 'Control', 'description': 'The placebo group will receive a biscuit an isocaloric control biscuit that is similar in taste and texture and without pulse fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.\n\nControl: Control biscuit with no yellow pea hull fibre.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.92', 'spread': '.22', 'groupId': 'OG000'}, {'value': '2.90', 'spread': '.21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Serum LDL (low density lipoprotein) cholesterol', 'unitOfMeasure': 'mmol/l', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Serum Cytokine at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pulse Fibre', 'description': 'The intervention group will receive a biscuit containing 5g/serving of yellow pea fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.\n\nPulse fibre: Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.'}, {'id': 'OG001', 'title': 'Control', 'description': 'The placebo group will receive a biscuit an isocaloric control biscuit that is similar in taste and texture and without pulse fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.\n\nControl: Control biscuit with no yellow pea hull fibre.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.89', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '1.28', 'spread': '0.29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Serum cytokine IL-6 measured at 12 weeks', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Alpha Diversity of Gut Microbiota at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pulse Fibre', 'description': 'The intervention group will receive a biscuit containing 5g/serving of yellow pea fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.\n\nPulse fibre: Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.'}, {'id': 'OG001', 'title': 'Control', 'description': 'The placebo group will receive a biscuit an isocaloric control biscuit that is similar in taste and texture and without pulse fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.\n\nControl: Control biscuit with no yellow pea hull fibre.'}], 'classes': [{'categories': [{'measurements': [{'value': '493', 'spread': '132', 'groupId': 'OG000'}, {'value': '512', 'spread': '117', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Gut microbiota alpha diversity measured at 12 weeks as Chao index. Chao index is an abundance-based estimator of species richness within a sample. There are no preset minimum and maximum values but scores typically range from 0 to 4000. A higher score is generally regarded as better.', 'unitOfMeasure': 'Score on a scale of 1-4000', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Serum Metabolomics at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pulse Fibre', 'description': 'The intervention group will receive a biscuit containing 5g/serving of yellow pea fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.\n\nPulse fibre: Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.'}, {'id': 'OG001', 'title': 'Control', 'description': 'The placebo group will receive a biscuit an isocaloric control biscuit that is similar in taste and texture and without pulse fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.\n\nControl: Control biscuit with no yellow pea hull fibre.'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'Serum metabolomics measured at 12 weeks using 1H-NMR analysis. Principal component analysis is used to see if two or more groups of samples separate into distinct clusters. The principal components generated in this analysis range from 0-100%. A higher value means that more variability among the samples is explained by this principal component.', 'unitOfMeasure': 'score on a scale of 1-100%', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Fecal Short-chain Fatty Acid Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pulse Fibre', 'description': 'The intervention group will receive a biscuit containing 5g/serving of yellow pea fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.\n\nPulse fibre: Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.'}, {'id': 'OG001', 'title': 'Control', 'description': 'The placebo group will receive a biscuit an isocaloric control biscuit that is similar in taste and texture and without pulse fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.\n\nControl: Control biscuit with no yellow pea hull fibre.'}], 'classes': [{'categories': [{'measurements': [{'value': '112.7', 'spread': '15.5', 'groupId': 'OG000'}, {'value': '82.99', 'spread': '12.97', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Fecal acetate concentration measured at 12 weeks', 'unitOfMeasure': 'µmol/g dry weight', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Fecal Bile Acid Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pulse Fibre', 'description': 'The intervention group will receive a biscuit containing 5g/serving of yellow pea fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.\n\nPulse fibre: Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.'}, {'id': 'OG001', 'title': 'Control', 'description': 'The placebo group will receive a biscuit an isocaloric control biscuit that is similar in taste and texture and without pulse fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.\n\nControl: Control biscuit with no yellow pea hull fibre.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.38', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '1.99', 'spread': '0.20', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Fecal cholic acid concentration measured at 12 weeks', 'unitOfMeasure': 'µmol/g dry weight', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pulse Fibre', 'description': 'The intervention group will receive a biscuit containing 5g/serving of yellow pea fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.\n\nPulse fibre: Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.'}, {'id': 'FG001', 'title': 'Control', 'description': 'The placebo group will receive a biscuit an isocaloric control biscuit that is similar in taste and texture and without pulse fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.\n\nControl: Control biscuit with no yellow pea hull fibre.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pulse Fibre', 'description': 'The intervention group will receive a biscuit containing 5g/serving of yellow pea fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.\n\nPulse fibre: Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.'}, {'id': 'BG001', 'title': 'Control', 'description': 'The placebo group will receive a biscuit an isocaloric control biscuit that is similar in taste and texture and without pulse fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.\n\nControl: Control biscuit with no yellow pea hull fibre.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.5', 'spread': '8.1', 'groupId': 'BG000'}, {'value': '44.3', 'spread': '9.5', 'groupId': 'BG001'}, {'value': '43.9', 'spread': '14.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2018-11-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-16', 'studyFirstSubmitDate': '2012-10-23', 'resultsFirstSubmitDate': '2019-04-15', 'studyFirstSubmitQcDate': '2012-10-30', 'lastUpdatePostDateStruct': {'date': '2020-01-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-16', 'studyFirstPostDateStruct': {'date': '2012-11-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-01-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cholesterol Profile at 12 Weeks', 'timeFrame': '12 weeks', 'description': 'Serum LDL (low density lipoprotein) cholesterol'}, {'measure': 'Serum Cytokine at 12 Weeks', 'timeFrame': '12 weeks', 'description': 'Serum cytokine IL-6 measured at 12 weeks'}, {'measure': 'Alpha Diversity of Gut Microbiota at 12 Weeks', 'timeFrame': '12 weeks', 'description': 'Gut microbiota alpha diversity measured at 12 weeks as Chao index. Chao index is an abundance-based estimator of species richness within a sample. There are no preset minimum and maximum values but scores typically range from 0 to 4000. A higher score is generally regarded as better.'}, {'measure': 'Serum Metabolomics at 12 Weeks', 'timeFrame': '12 weeks', 'description': 'Serum metabolomics measured at 12 weeks using 1H-NMR analysis. Principal component analysis is used to see if two or more groups of samples separate into distinct clusters. The principal components generated in this analysis range from 0-100%. A higher value means that more variability among the samples is explained by this principal component.'}, {'measure': 'Fecal Short-chain Fatty Acid Concentrations', 'timeFrame': '12 weeks', 'description': 'Fecal acetate concentration measured at 12 weeks'}, {'measure': 'Fecal Bile Acid Concentration', 'timeFrame': '12 weeks', 'description': 'Fecal cholic acid concentration measured at 12 weeks'}], 'primaryOutcomes': [{'measure': 'Change in Fat Mass at 12 Weeks', 'timeFrame': 'Value at 12 weeks minus value at baseline', 'description': 'Value at 12 weeks minus value at baseline assessed with dual energy x-ray absorptiometry.'}], 'secondaryOutcomes': [{'measure': 'HbA1c at 12 Weeks', 'timeFrame': '12 weeks', 'description': 'Assessed via HbA1c'}, {'measure': 'Change in Objective Appetite at 12 Weeks', 'timeFrame': '12 weeks minus baseline', 'description': 'Value at 12 weeks minus baseline energy intake during weighed lunch buffet.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Dietary intervention', 'Dietary fibre', 'Obesity', 'Metabolic syndrome', 'Weight loss', 'Glucose regulation', 'Pulse fibre'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '24712378', 'type': 'BACKGROUND', 'citation': 'Lambert JE, Parnell JA, Han J, Sturzenegger T, Paul HA, Vogel HJ, Reimer RA. Evaluation of yellow pea fibre supplementation on weight loss and the gut microbiota: a randomized controlled trial. BMC Gastroenterol. 2014 Apr 8;14:69. doi: 10.1186/1471-230X-14-69.'}, {'pmid': '26811130', 'type': 'RESULT', 'citation': 'Lambert JE, Parnell JA, Tunnicliffe JM, Han J, Sturzenegger T, Reimer RA. Consuming yellow pea fiber reduces voluntary energy intake and body fat in overweight/obese adults in a 12-week randomized controlled trial. Clin Nutr. 2017 Feb;36(1):126-133. doi: 10.1016/j.clnu.2015.12.016. Epub 2016 Jan 11.'}, {'pmid': '30572270', 'type': 'RESULT', 'citation': 'Mayengbam S, Lambert JE, Parnell JA, Tunnicliffe JM, Nicolucci AC, Han J, Sturzenegger T, Shearer J, Mickiewicz B, Vogel HJ, Madsen KL, Reimer RA. Impact of dietary fiber supplementation on modulating microbiota-host-metabolic axes in obesity. J Nutr Biochem. 2019 Feb;64:228-236. doi: 10.1016/j.jnutbio.2018.11.003. Epub 2018 Nov 26.'}]}, 'descriptionModule': {'briefSummary': 'The recent dramatic increase in obesity has been linked to a reduction of dietary fibre intake. We hypothesized that supplementing the diet of overweight and obesity adults with pulse fibre will improve their metabolic status, chiefly defined as greater weight loss. Other metabolic health improvements may include improved glucose control and reduced inflammatory markers.', 'detailedDescription': 'The main objective of our study is to assess the effects of pulse fibre supplementation on weight loss in an overweight and obese adult population.\n\nPrimary objective - To determine the effects of a 12 week intake of 15g/day of pea hull fibre on weight loss supported by body composition measures.\n\nSecondary objective - To measure glucose control and appetite regulation in overweight and obese adults consuming 15g/day of pea hull fibre compared to a placebo control with the use of plasma HbA1c and an oral glucose tolerance test (OGTT).\n\nTertiary objective - To examine mechanisms of action of pulse fibre supplementation by determining the impact of pulse fibre supplementation on gut microbiota, serum metabolomics and fecal short-chain fatty acid and bile acid concentrations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females\n* Age 18 - 70 years\n* BMI 25 - 38 kg/m-2\n* Stable body weight for at least 3 months prior to the study\n\nExclusion Criteria:\n\n* Concomitant use of any weight loss medication, diet or exercise regime\n* Use of corticosteroids, anti-depressants, anti-epileptic medications, lipid lowering medication, diabetes medications\n* Previous bariatric or other intestinal surgeries\n* Pregnancy or lactation\n* Weight loss \\> 3 kg within preceding 3 months to enrollment\n* Use of bulk laxatives or probiotics/prebiotics supplements\n* Antibiotic use in the past month\n* Clinically significant cardiovascular or respiratory or liver disease'}, 'identificationModule': {'nctId': 'NCT01719900', 'briefTitle': 'Evaluation of Pulse Fibre Supplementation on Obesity and the Metabolic Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University of Calgary'}, 'officialTitle': 'Evaluation of Pulse Fibre Supplementation in Obesity and the Metabolic Syndrome: Generating Evidence in Support of Health Claims', 'orgStudyIdInfo': {'id': '24804'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pulse Fibre', 'description': 'The intervention group will receive a biscuit containing 5g/serving of yellow pea fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.', 'interventionNames': ['Dietary Supplement: Pulse fibre']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'The placebo group will receive a biscuit an isocaloric control biscuit that is similar in taste and texture and without pulse fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.', 'interventionNames': ['Dietary Supplement: Control']}], 'interventions': [{'name': 'Pulse fibre', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.', 'armGroupLabels': ['Pulse Fibre']}, {'name': 'Control', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Control biscuit with no yellow pea hull fibre.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 1N4', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Calgary', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}], 'overallOfficials': [{'name': 'Raylene Reimer, PhD, RD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Calgary'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Calgary', 'class': 'OTHER'}, 'collaborators': [{'name': 'Alberta Innovates Health Solutions', 'class': 'OTHER'}, {'name': 'Alberta Innovates Bio Solutions', 'class': 'OTHER'}, {'name': 'Alberta Pulse Growers', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Faculty of Kinesiology', 'investigatorFullName': 'Dr. Raylene Reimer', 'investigatorAffiliation': 'University of Calgary'}}}}