Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-28 @ 1:43 AM
Study NCT ID:
NCT04795804
Status:
COMPLETED
Last Update Posted:
2021-11-03
First Post:
2020-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Human Milk Oligossaccharide and Acetate Production in Vivo
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], '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': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C008315', 'term': 'maltodextrin'}, {'id': 'D000084922', 'term': 'Resistant Starch'}], 'ancestors': [{'id': 'D013213', 'term': 'Starch'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D004043', 'term': 'Dietary Fiber'}, {'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-02', 'studyFirstSubmitDate': '2020-12-04', 'studyFirstSubmitQcDate': '2021-03-09', 'lastUpdatePostDateStruct': {'date': '2021-11-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma acetate concentrations.', 'timeFrame': 'plasma acetate will be sampled during the CID before the consumption of a liquid high fat mixed meal', 'description': 'During the clinical investigation day plasma acetate will be sampled'}, {'measure': 'Plasma acetate concentrations.', 'timeFrame': 'plasma acetate will be sampled during the CID at t=60 minutes after consumption of a liquid high fat mixed meal', 'description': 'During the clinical investigation day plasma acetate will be sampled'}, {'measure': 'Plasma acetate concentrations.', 'timeFrame': 'plasma acetate will be sampled during the CID at t=120 minutes after consumption of a liquid high fat mixed meal', 'description': 'During the clinical investigation day plasma acetate will be sampled'}, {'measure': 'Plasma acetate concentrations.', 'timeFrame': 'plasma acetate will be sampled during the CID at t=240 minutes after consumption of a liquid high fat mixed meal', 'description': 'During the clinical investigation day plasma acetate will be sampled'}, {'measure': 'Faecal acetate concentrations.', 'timeFrame': 'Fecal acetate will be sampled in the morning before the testday', 'description': 'On the day of clinical investigation day, fecal acetate will be sampled'}, {'measure': 'Plasma butyrate concentrations.', 'timeFrame': 'plasma butyrate will be sampled during the CID before the consumption of a liquid high fat mixed meal', 'description': 'During the clinical investigation day, plasma butyrate will be sampled'}, {'measure': 'Plasma butyrate concentrations.', 'timeFrame': 'plasma butyrate will be sampled during the CID at t=60 after consumption of a liquid high fat mixed meal', 'description': 'During the clinical investigation day, plasma butyrate will be sampled'}, {'measure': 'Plasma butyrate concentrations.', 'timeFrame': 'plasma butyrate will be sampled during the CID at t=120 after consumption of a liquid high fat mixed meal', 'description': 'During the clinical investigation day, plasma butyrate will be sampled'}, {'measure': 'Plasma butyrate concentrations.', 'timeFrame': 'plasma butyrate will be sampled during the CID at t=240 minutes after consumption of a liquid high fat mixed meal', 'description': 'During the clinical investigation day, plasma butyrate will be sampled'}, {'measure': 'Fecal butyrate concentrations.', 'timeFrame': 'Fecal butyrate will be sampled in the morning before the testday', 'description': 'On the day of clinical investigation day, fecal butyrate will be sampled'}, {'measure': 'Plasma propionate concentrations.', 'timeFrame': 'Plasma propionate will be sampled during the CID before the consumption of a liquid high fat mixed meal', 'description': 'During the clinical investigation day, plasma propionate will be sampled'}, {'measure': 'Plasma propionate concentrations.', 'timeFrame': 'Plasma propionate will be sampled during the CID t=60 minutes after the consumption of a liquid high fat mixed meal', 'description': 'During the clinical investigation day, plasma propionate will be sampled'}, {'measure': 'Plasma propionate concentrations.', 'timeFrame': 'Plasma propionate will be sampled during the CID t=120 minutes after the consumption of a liquid high fat mixed meal', 'description': 'During the clinical investigation day, plasma propionate will be sampled'}, {'measure': 'Plasma propionate concentrations.', 'timeFrame': 'Plasma propionate will be sampled during the CID t=240 minutes after the consumption of a liquid high fat mixed meal', 'description': 'During the clinical investigation day, plasma propionate will be sampled'}, {'measure': 'Faecal propionate concentrations.', 'timeFrame': 'Fecal propionate will be sampled in the morning before the testday', 'description': 'On the day of clinical investigation day, fecal propionate will be sampled'}], 'secondaryOutcomes': [{'measure': 'Energy expenditure, fat and carbohydrate oxidation', 'timeFrame': 'Indirect calorimetry will be measured before and for 4 hours after the consumption of the liquid high-fat mixed meal during the whole CID', 'description': 'Energy expenditure, fat and carbohydrate oxidation will be measured using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands);'}, {'measure': 'Breath H2 using (Bedfont EC60 Gastrolyzer, Rochester, UK).', 'timeFrame': 'Breath H2 will be sampled during the CID before and at t=30, t=60, t=90, t=120 and t=240 minutes after consumption of a liquid high fat mixed meal', 'description': 'Breath H2 using (Bedfont EC60 Gastrolyzer, Rochester, UK).'}, {'measure': 'Plasma glucose concentrations', 'timeFrame': 'Plasma glucose concentrations will be sampled during the CID before and t=0, t=30, t=60, t=120 and t=240 minutes after consumption of a liquid high fat mixed meal', 'description': 'Plasma glucose concentrations'}, {'measure': 'Plasma insulin concentrations', 'timeFrame': 'Plasma insulin concentrations will be sampled during the CID before and at t=0, t=30, t=60, t=120 and t=240 minutes after consumption of a liquid high fat mixed meal', 'description': 'Plasma insulin concentrations'}, {'measure': 'Plasma FFA concentrations', 'timeFrame': 'Plasma FFA concentrations will be sampled during the CID before and at t=0, t=30, t=60, t=120 and t=240 minutes after consumption of a liquid high fat mixed meal', 'description': 'Plasma FFA concentrations'}, {'measure': 'Faecal microbiota composition', 'timeFrame': 'Faecal microbiota composition will be sampled in the morning before the testday', 'description': 'Faecal microbiota composition will be assessed via16S rRNA gene sequencing'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity', 'Insulin Resistance']}, 'referencesModule': {'references': [{'pmid': '37529001', 'type': 'DERIVED', 'citation': "Canfora EE, Vliex LMM, Wang T, Nauta A, Bouwman FG, Holst JJ, Venema K, Zoetendal EG, Blaak EE. 2'-fucosyllactose alone or combined with resistant starch increases circulating short-chain fatty acids in lean men and men with prediabetes and obesity. Front Nutr. 2023 Jul 17;10:1200645. doi: 10.3389/fnut.2023.1200645. eCollection 2023."}]}, 'descriptionModule': {'briefSummary': 'The study investigators hypothesize (1) that the SCFA/acetate metabolism differs between metabolic phenotypes and (2) that using a mixture of fibres that differ in degree of polymerization and branching namely a resistant starch and a human-like milk oligosaccharide enhance the acetate availability in the distal colon and systemic circulation, consequently leading to its metabolic effects.\n\nTo study this, the investigators will supplement lean, normoglycaemic vs. overweight/obese, prediabetic men with the fibre mixture the day before the clinical investigation day (CID) and study during the CID its effects on fasting and postprandial substrate and energy metabolism.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\nLean (BMI ≥ 20kg/m2 and ≤ 24.9kg/m2) healthy men aged 30 - 65 years\n\nas well as\n\noverweight/obese (BMI ≥ 25kg/m2 and ≤ 34.9kg/m2) prediabetic men aged between 30 - 65 years\n\nExclusion criteria:\n\n* Type 2 diabetes mellitus (defined as fasting plasma glucose ≥ 7.1 mmol/L and 2h glucose ≥ 11.1 mmol/L)\n* Gastroenterological diseases or abdominal surgery;\n* Cardiovascular diseases, cancer, liver or kidney malfunction, disease with a life expectancy shorter than 5 years;\n* Abuse of products; alcohol and drugs, excessive nicotine use defined as \\>20 cigarettes per day;\n* Plans to lose weight or following of a hypocaloric diet;\n* Regular supplementation of pre- or probiotic products, use of pre- or probiotics 3 months prior to the start of the study;\n* Intensive exercise training more than three hours a week;\n* Use of any medication that influences glucose or fat metabolism and inflammation (i.e. NSAIDs);\n* Regular use of laxation products;\n* Use of antibiotics in the last three months (antibiotics use can alter substantially the gut microbiota composition).\n* Follow a vegan diet.'}, 'identificationModule': {'nctId': 'NCT04795804', 'briefTitle': 'Human Milk Oligossaccharide and Acetate Production in Vivo', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'The Effects of Human-like Milk Oligosaccharide and Resistant Starch on Acetate Production and Human Substrate Metabolism', 'orgStudyIdInfo': {'id': 'NL71611.068.19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '11.43 g (3 x 3.81 g) maltodextrin the day before the clinical investigation day', 'interventionNames': ['Dietary Supplement: Maltodextrin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Human milk-like oligosaccharide alone', 'description': '12 g (3 x 4 g) of the human milk-like oligosaccharide the day before the clinical investigation day', 'interventionNames': ['Dietary Supplement: Human Milk Oligossaccharide']}, {'type': 'EXPERIMENTAL', 'label': 'Human milk-like oligosaccharide and resistant starch', 'description': '12 g (3 x 4 g) of the human milk-like oligosaccharide and 7.5g resistant starch (3 x 2.5 g) the day before the clinical investigation day', 'interventionNames': ['Dietary Supplement: Human Milk Oligossaccharide and resistant starch']}], 'interventions': [{'name': 'Human Milk Oligossaccharide', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The day before the CIDs, the participants receive the supplements 3x a day in randomized order', 'armGroupLabels': ['Human milk-like oligosaccharide alone']}, {'name': 'Maltodextrin', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The day before the CIDs, the participants receive the supplements 3x a day in randomized order', 'armGroupLabels': ['Placebo']}, {'name': 'Human Milk Oligossaccharide and resistant starch', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The day before the CIDs, the participants receive the supplements 3x a day in randomized order', 'armGroupLabels': ['Human milk-like oligosaccharide and resistant starch']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5229ER', 'city': 'Maastricht', 'state': 'Limburg', 'country': 'Netherlands', 'facility': 'Maastricht University', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}