Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:29 AM
Study NCT ID:
NCT01004120
Status:
COMPLETED
Last Update Posted:
2016-03-25
First Post:
2009-10-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of a Prebiotic Galactooligosaccharide to Reduce Metabolic Syndrome Risk Factors in Overweight Adults
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': 'C072242', 'term': "4'-galactooligosaccharide"}, {'id': 'C008315', 'term': 'maltodextrin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-24', 'studyFirstSubmitDate': '2009-10-28', 'studyFirstSubmitQcDate': '2009-10-28', 'lastUpdatePostDateStruct': {'date': '2016-03-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Faecal microbiota changes enumerated by Fluorescent In Situ Hybridisation and qualitatively assessed by Denaturing Gradient Gel Electrophoresis.', 'timeFrame': '3 months'}, {'measure': 'Lipid profile (total, LDL and HDL cholesterol, triglycerides and non-esterified fatty acids)', 'timeFrame': '3 months'}, {'measure': 'Inflammatory/thrombotic biomarkers (including C-reactive protein, TNF-a, IL6, IL-8, IL-10, sCD40L, sP-selectin, t-PA)', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Insulin resistance derived from fasted measures of glucose and insulin ratio', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Metabolic Syndrome X']}, 'referencesModule': {'references': [{'pmid': '23303873', 'type': 'DERIVED', 'citation': 'Vulevic J, Juric A, Tzortzis G, Gibson GR. A mixture of trans-galactooligosaccharides reduces markers of metabolic syndrome and modulates the fecal microbiota and immune function of overweight adults. J Nutr. 2013 Mar;143(3):324-31. doi: 10.3945/jn.112.166132. Epub 2013 Jan 9.'}]}, 'descriptionModule': {'briefSummary': 'The traditional risk factors for obesity are inappropriate diet, lack of exercise and genetic factors. However, recent observations have involved gut microbiota profiles as having an additional influence. In this case, there exists the possibility to modulate this through diet. Research has shown that the gut microbiota of both obese humans and mouse models of obesity is altered towards less beneficial one compared to lean counterparts. This raises the possibility of modulating the gut microbiota as a novel strategy in tackling the epidemic of obesity and diabetes sweeping the developed world. In addition, a more direct effect of high-fat induced disruption of the intestinal microbiota has also been seen with a murine model. Elevated circulating levels of lipopolysaccharide (LPS) a major building block and antigen of Gram-negative bacteria, was shown to generate a low grade chronic inflammation, termed metabolic endotoxemia, which then onsets insulin resistance. High-fat diets were shown to disrupt the Gram-negative intestinal populations of these animals, liberating LPS. The effects of prebiotics on the microbiota or metabolic syndrome (combination of disorders that increase the risk of developing cardiovascular disease and diabetes) in overweight adults have not been investigated thus far. The investigators therefore propose to investigate the effect of galactooligosaccharide (GOS) on the faecal microbiota and metabolic syndrome risk factors in overweight adults in a double-blind, randomised, placebo controlled, cross-over trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-65y\n* BMI \\>25 kg/m2\n\nExclusion Criteria:\n\n* Suffered from a myocardial infarction/stroke or cancer in the past 12 months\n* Diabetic or suffering from endocrine disorders\n* Suffer from renal or bowel disease/gut disorder or have a history of cholestatic jaundice or pancreatitis\n* Requirements to take long-term medication for hyperlipidaemia, hypertension, inflammation or hypercoagulation\n* History of alcohol or drug abuse\n* Planning or on a weight reducing regime\n* Taking antioxidant (or phytochemical), probiotic or prebiotics supplements\n* Pregnant or lactating women or those planning pregnancy in the next 6 months or of child-bearing age who are not using contraception\n* Use of antibiotics within the previous 1 month\n* Anemic\n* Smoker'}, 'identificationModule': {'nctId': 'NCT01004120', 'briefTitle': 'Efficacy of a Prebiotic Galactooligosaccharide to Reduce Metabolic Syndrome Risk Factors in Overweight Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Clasado'}, 'officialTitle': 'Double-blind, Placebo Controlled, Randomised, Cross-over Study to Determine the Effect of a Prebiotic Galactooligosaccharide on Microbiota and Metabolic Syndrome Risk Factors in Overweight Adults', 'orgStudyIdInfo': {'id': 'COMSE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'MDn', 'interventionNames': ['Dietary Supplement: Maltodextrin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B-GOS', 'interventionNames': ['Dietary Supplement: Bimuno']}], 'interventions': [{'name': 'Bimuno', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Galactooligosaccharide'], 'description': '5.5g daily intake', 'armGroupLabels': ['B-GOS']}, {'name': 'Maltodextrin', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Dexrins'], 'description': '5.5g daily intake', 'armGroupLabels': ['MDn']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'RG6 6AU', 'city': 'Reading', 'state': 'Berkshire', 'country': 'United Kingdom', 'facility': 'School of Chemistry, Food Biosciences and Pharmacy, The University of Reading', 'geoPoint': {'lat': 51.45625, 'lon': -0.97113}}], 'overallOfficials': [{'name': 'Jelena Vulevic, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Reading'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clasado', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Reading', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}