Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2025-12-25 @ 4:43 PM
Study NCT ID:
NCT05349903
Status:
COMPLETED
Last Update Posted:
2022-04-27
First Post:
2021-10-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Slowly Digestible Carbohydrates on the Gut-brain Axis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001070', 'term': 'Appetitive Behavior'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}, {'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': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005433', 'term': 'Flour'}, {'id': 'D007444', 'term': 'Inulin'}, {'id': 'C045651', 'term': 'epigallocatechin gallate'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D013213', 'term': 'Starch'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D005630', 'term': 'Fructans'}, {'id': 'D011134', 'term': 'Polysaccharides'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-02-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-22', 'studyFirstSubmitDate': '2021-10-06', 'studyFirstSubmitQcDate': '2022-04-22', 'lastUpdatePostDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postprandial glycemic response', 'timeFrame': 'Acute study: [4 hours of measurement after consumption of test food]', 'description': 'Blood plasma glucose will be measured, (AUC)'}, {'measure': 'Postprandial glycemic response', 'timeFrame': 'Acute study: [4 hours of measurement after consumption of test food]', 'description': 'Blood plasma glucose will be measured, (C max)'}, {'measure': 'Postprandial glycemic response', 'timeFrame': 'Acute study: [4 hours of measurement after consumption of test food]', 'description': 'Blood plasma glucose will be measured, (t max)'}, {'measure': 'Postprandial plasma gut hormone response', 'timeFrame': 'Acute study: [4 hours of measurement after consumption of test food]', 'description': 'Blood plasma glucagon-like peptide-1 and insulin will be measured, (AUC)'}, {'measure': 'Postprandial plasma gut hormone response', 'timeFrame': 'Acute study: [4 hours of measurement after consumption of test food]', 'description': 'Blood plasma glucagon-like peptide-1 and insulin will be measured, (C max)'}, {'measure': 'Postprandial plasma gut hormone response', 'timeFrame': 'Acute study: [4 hours of measurement after consumption of test food]', 'description': 'Blood plasma glucagon-like peptide-1 and insulin will be measured, (t max)'}], 'secondaryOutcomes': [{'measure': 'Gastric emptying rate', 'timeFrame': 'Acute study: 4 hours of measurement after consumption of test food]', 'description': 'Breath test will be performed using 13C-acetate mixed into test meals'}, {'measure': 'Appetite ratings (Visual Analog Scale, VAS)', 'timeFrame': 'Acute study: [4 hours of measurement after consumption of test food]', 'description': 'Hunger and fullness scores will be measured using a 10-cm scale (0 = weakest feeling of hunger or fullness and 10 = strongest feeling of hunger or fullness) after consumption of test food. Weaker feelings of hunger and stronger feelings of fullness indicate better outcomes.'}, {'measure': 'Food Intake of the next meal', 'timeFrame': 'Acute study: After the consumption a second meal [4 hours later after consuming the first meal]', 'description': 'At the end of the 4 hour window, participants will be given a large second meal for consumption and the amount of consumed food (food intake) will be estimated.'}, {'measure': 'Breath hydrogen (fermentability)', 'timeFrame': 'Acute study: [4 hours of measurement after consumption of test food]', 'description': "Breath samples will be collected in 15-minute intervals for 4 hours after consumption of test food and analyzed for hydrogen levels using a breath analyzer. Breath hydrogen levels are indicative of a food's fermentability."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Appetitive Behavior', 'Obesity', 'Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'Our laboratory is investigating the physiological outcomes and health benefits of the consumption of high-quality carbohydrates. One important aspect of the high-quality carbohydrate characteristics is a slow and sustained digestion and glucose release to the blood. In the proposed study, the investigators will evaluate the consumption of different types of slowly digestible carbohydrates (SDCs) and their beneficial effects including moderation of the glycemic response profile (postprandial glycemic response, PPGR) and stimulation of the gut-brain axis, which controls appetite and food intake. This stimulation will be evaluated in terms of second-meal food intake and the circulatory level of appetite-suppressing gut hormones (such as glucagon-like peptide-1).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '22 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI 18.5 - 25 kg/m2\n* Stable weight for the past 3 months (i.e. +/- 2..5 kg)\n\nExclusion Criteria:\n\n* Pregnant or nursing women\n* Diabetic\n* Individuals with history of gastrointestinal disease'}, 'identificationModule': {'nctId': 'NCT05349903', 'briefTitle': 'Impact of Slowly Digestible Carbohydrates on the Gut-brain Axis', 'organization': {'class': 'OTHER', 'fullName': 'Purdue University'}, 'officialTitle': 'Impact of Slowly Digestible Carbohydrates on the Gut-brain Axis', 'orgStudyIdInfo': {'id': 'IRB-2020-986'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rice flour', 'description': 'Rapidly digestible control', 'interventionNames': ['Other: Rice flour']}, {'type': 'EXPERIMENTAL', 'label': 'Alternanoligosaccharide 15', 'interventionNames': ['Other: Alternanoligosaccharide 15']}, {'type': 'EXPERIMENTAL', 'label': 'Waxy potato starch', 'interventionNames': ['Other: Waxy potato starch']}, {'type': 'EXPERIMENTAL', 'label': 'Combination of waxy potato starch and epigallocatechin gallate (EGCG)', 'interventionNames': ['Other: Waxy potato starch + epigallocatechin gallate (EGCG)']}, {'type': 'EXPERIMENTAL', 'label': 'Combination of chickpea flour and epigallocatechin gallate (EGCG)', 'interventionNames': ['Other: Chickpea flour + epigallocatechin gallate (EGCG)']}, {'type': 'EXPERIMENTAL', 'label': 'Inulin', 'interventionNames': ['Other: Inulin']}], 'interventions': [{'name': 'Rice flour', 'type': 'OTHER', 'description': 'Rice flour made into rice porridge will be tested for postprandial glycemic response, gut hormone levels, gastric emptying rate, appetitive response, and fermentability.', 'armGroupLabels': ['Rice flour']}, {'name': 'Alternanoligosaccharide 15', 'type': 'OTHER', 'description': 'Alternanoligosaccharide 15 incorporated into rice porridge will be tested for postprandial glycemic response, gut hormone levels, gastric emptying rate, appetitive response, and fermentability.', 'armGroupLabels': ['Alternanoligosaccharide 15']}, {'name': 'Inulin', 'type': 'OTHER', 'description': 'Inulin incorporated into rice porridge will be tested for postprandial glycemic response, gut hormone levels, gastric emptying rate, appetitive response, and fermentability.', 'armGroupLabels': ['Inulin']}, {'name': 'Waxy potato starch', 'type': 'OTHER', 'description': 'Retrograded waxy potato starch made into porridge meal will be tested for postprandial glycemic response, gut hormone levels, gastric emptying rate, appetitive response, and fermentability.', 'armGroupLabels': ['Waxy potato starch']}, {'name': 'Waxy potato starch + epigallocatechin gallate (EGCG)', 'type': 'OTHER', 'description': 'A combination of retrograded waxy potato starch and EGCG made into porridge meal will be tested for postprandial glycemic response, gut hormone levels, gastric emptying rate, appetitive response, and fermentability.', 'armGroupLabels': ['Combination of waxy potato starch and epigallocatechin gallate (EGCG)']}, {'name': 'Chickpea flour + epigallocatechin gallate (EGCG)', 'type': 'OTHER', 'description': 'A combination of chickpea flour and EGCG made into porridge meal will be tested for postprandial glycemic response, gut hormone levels, gastric emptying rate, appetitive response, and fermentability.', 'armGroupLabels': ['Combination of chickpea flour and epigallocatechin gallate (EGCG)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47907', 'city': 'West Lafayette', 'state': 'Indiana', 'country': 'United States', 'facility': 'Purdue University', 'geoPoint': {'lat': 40.42587, 'lon': -86.90807}}], 'overallOfficials': [{'name': 'Bruce R Hamaker, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Purdue University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be made available to other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Purdue University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Distinguished Professor of Food Science', 'investigatorFullName': 'Bruce R. Hamaker', 'investigatorAffiliation': 'Purdue University'}}}}