Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-02-23 @ 4:31 AM
Study NCT ID:
NCT03042494
Status:
COMPLETED
Last Update Posted:
2023-05-09
First Post:
2017-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Prebiotic Intake on Gut Microbiota in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D056692', 'term': 'Prebiotics'}], 'ancestors': [{'id': 'D004043', 'term': 'Dietary Fiber'}, {'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011135', 'term': 'Polysaccharides, Bacterial'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Crossover design with 4 week washout period.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-08', 'studyFirstSubmitDate': '2017-02-01', 'studyFirstSubmitQcDate': '2017-02-01', 'lastUpdatePostDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in baseline fecal bifidobacteria at 4 weeks', 'timeFrame': '4 weeks in cross-over design', 'description': 'Assessed with 16S rRNA sequencing.'}], 'secondaryOutcomes': [{'measure': 'Change in baseline fecal short chain fatty acid concentrations at 4 weeks', 'timeFrame': '4 weeks in cross-over design', 'description': 'Analyzed with gas chromatography/mass spectrophotometry'}, {'measure': 'Change in baseline gastrointestinal tolerance at 4 weeks', 'timeFrame': '4 weeks in cross-over design', 'description': 'Analyzed with questionnaire'}, {'measure': 'Change in baseline quality of life rating at 4 weeks', 'timeFrame': '4 weeks in cross-over design', 'description': 'Measured with SF-36 questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prebiotic', 'Gut microbiota', 'Dietary fiber', 'Gastrointestinal tolerance'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '32320024', 'type': 'DERIVED', 'citation': 'Reimer RA, Soto-Vaca A, Nicolucci AC, Mayengbam S, Park H, Madsen KL, Menon R, Vaughan EE. Effect of chicory inulin-type fructan-containing snack bars on the human gut microbiota in low dietary fiber consumers in a randomized crossover trial. Am J Clin Nutr. 2020 Jun 1;111(6):1286-1296. doi: 10.1093/ajcn/nqaa074.'}]}, 'descriptionModule': {'briefSummary': 'In recent years, the importance of the gut microbiota to human health has been demonstrated. In adulthood, the microbial profile is relatively stable, yet can be transiently altered by factors such as diet or antibiotic treatment. Such changes may be beneficial, as gut microbiota has been shown to differ in normal versus disease states including inflammatory bowel disease, obesity, type 2 diabetes and fatty liver disease. Given this relationship, there is intense interest in designing interventions that positively influence the gut microbial profile. Prebiotics are non-digestible, fermentable oligo- and polysaccharides that alter the colonic environment in favour of health-promoting bacterial species, such as bifidobacteria which selectively ferment prebiotics. Given the ability of prebiotics to beneficially alter the microbial profile, there is a need to identify the dosing requirements to positively modulate the gut microbiota. This study will test the effect of two doses of prebiotic on gut microbiota taxonomy and diversity.', 'detailedDescription': 'The primary objective is to determine the effect of 4 week intake of a moderate dose (7 g/d) or low dose (2.5-3 g/d) of prebiotic on gut microbiota profiles in healthy adults compared to a non-prebiotic containing control.\n\nThe primary outcome is change in microbial composition (measured via 16S rRNA sequencing).\n\nThe secondary outcomes are change in gastrointestinal (GI) tolerance (measured via questionnaire); change in fecal short chain fatty acids; and change in quality of life.\n\nThis study will consist of two separate trials of 12 week duration. Each trial will be performed in a double-blind, randomized, placebo-controlled crossover manner with a 4 week intervention period followed by a 4 week wash-out period and final 4 week cross over.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male and female subjects who are regular snack consumers\n* Not obese (BMI ≥ 18.5 kg/m2 and ≤ 29.9 kg/m2)\n* 18 and 65 years of age\n* Stable bodyweight for at least 3-months prior to the study.\n\nExclusion Criteria:\n\n* Chronic disease including but not limited to type 1 or 2 diabetes, cardiovascular disease, liver or pancreas disease.\n* Major gastrointestinal surgery\n* Pregnant or lactating\n* Antibiotic use in the preceding 3 months\n* Currently consume probiotic or prebiotics supplements\n* Currently consume more than 15 g/d of fiber in women and 18 g/d in men\n* Are following a diet or exercise regime designed for weight loss\n* Have a BMI greater than 29.9 kg/m2.\n* Subjects who are required to start an antibiotic regime during the study will be withdrawn.'}, 'identificationModule': {'nctId': 'NCT03042494', 'briefTitle': 'Effect of Prebiotic Intake on Gut Microbiota in Healthy Adults', 'organization': {'class': 'OTHER', 'fullName': 'University of Calgary'}, 'officialTitle': 'Effect of Prebiotic Intake on Gut Microbiota in Healthy Adults', 'orgStudyIdInfo': {'id': 'REB16-0388'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Isocaloric food without the test prebiotic.', 'interventionNames': ['Dietary Supplement: Control']}, {'type': 'EXPERIMENTAL', 'label': 'Prebiotic', 'description': 'Prebiotic consumed as one daily serving of 7 g in Group 1 and consumed as one daily serving of 2.5-3 g in Group 2.', 'interventionNames': ['Dietary Supplement: Prebiotic']}], 'interventions': [{'name': 'Control', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Isocaloric food without the test prebiotic.', 'armGroupLabels': ['Control']}, {'name': 'Prebiotic', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Prebiotic consumed as 7 g/d in a snack food in Group 1 and consumed as 2.5-3 g/d in a snack food in Group 2.', 'armGroupLabels': ['Prebiotic']}]}, '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': 'General Mills', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Dr. Raylene Reimer', 'investigatorAffiliation': 'University of Calgary'}}}}