Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2026-01-02 @ 6:47 AM
Study NCT ID:
NCT00616057
Status:
COMPLETED
Last Update Posted:
2012-07-06
First Post:
2008-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Fructans Supplementation on Parameters of Metabolic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007444', 'term': 'Inulin'}, {'id': 'C120489', 'term': 'oligofructose'}, {'id': 'C008315', 'term': 'maltodextrin'}], 'ancestors': [{'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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-04', 'studyFirstSubmitDate': '2008-02-04', 'studyFirstSubmitQcDate': '2008-02-04', 'lastUpdatePostDateStruct': {'date': '2012-07-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'gut microbiota composition', 'timeFrame': '3 months', 'description': 'HITChip analysis (phylogenetic profiling by DNA microarray)'}], 'secondaryOutcomes': [{'measure': 'gut microbial-related metabolites (in urine and plasma)', 'timeFrame': '3 months', 'description': 'NMR spectroscopic analysis of urine and plasma metabolic profiles'}, {'measure': 'metabolic parameters (weight, BMI, glycemia, fat mass,...)', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['fructans supplementation'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '24969566', 'type': 'DERIVED', 'citation': 'Salazar N, Dewulf EM, Neyrinck AM, Bindels LB, Cani PD, Mahillon J, de Vos WM, Thissen JP, Gueimonde M, de Los Reyes-Gavilan CG, Delzenne NM. Inulin-type fructans modulate intestinal Bifidobacterium species populations and decrease fecal short-chain fatty acids in obese women. Clin Nutr. 2015 Jun;34(3):501-7. doi: 10.1016/j.clnu.2014.06.001. Epub 2014 Jun 11.'}]}, 'descriptionModule': {'briefSummary': 'Obesity is constantly increasing, causing an important risk to develop diseases such as heart disease, diabetes,... Some recent studies have shown that obese people present modifications of colon microflora and a low-grade inflammation.\n\nIn our laboratory, we have demonstrated that the intake of fructans lessens dietary intake, body weight gain, adipose tissue accumulation and steatosis in rodents. These effects lead to an improvement of insulin resistance and hyperglycemia in diabetic rats and mice. Fructans are also able to restore the microflora disturbed by a high fat diet and to prevent endotoxemia. Moreover, studies have shown that fructans intake promotes satiety (Cani et al, Diabetes 2007) and or decreases fat mass (Abrams et al, Journal of Pediatrics 2007) in healthy human. An intervention study in obese patients is thus needed to study the effects of fructans in the target population.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI\\>30 kg/m2\n\nExclusion Criteria:\n\n* acute or chronic evoluting disease\n* alcohol consumption \\> 30 units/week\n* more than 30 minutes of sports 3 times/week\n* usual consumption of pre/probiotics or fibers supplement\n* recent consumption of antibiotics\n* slimming diet or unusual diet\n* pregnant women\n* anti-diabetics drugs ou slimming drugs\n* previous bariatric surgery\n* severe oesophagus reflux'}, 'identificationModule': {'nctId': 'NCT00616057', 'acronym': 'FRUCTOB', 'briefTitle': 'Evaluation of Fructans Supplementation on Parameters of Metabolic Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}, 'officialTitle': 'Evaluation of Fructans Supplementation on Parameters of Metabolic Syndrome', 'orgStudyIdInfo': {'id': '2007/21/NOV/300'}, 'secondaryIdInfos': [{'id': 'B40320072930'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'B', 'description': 'Maltodextrin, non digestible carbohydrate', 'interventionNames': ['Dietary Supplement: maltodextrin']}, {'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'fructans, non digestible carbohydrates fermented in the caeco-colon', 'interventionNames': ['Dietary Supplement: Synergy 1']}], 'interventions': [{'name': 'Synergy 1', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['inulin', 'oligofructose'], 'description': '8 grams/day during the first week and then 8 grams twice a day during 3 months', 'armGroupLabels': ['A']}, {'name': 'maltodextrin', 'type': 'DIETARY_SUPPLEMENT', 'description': '8 grams/day during the first week and then 8 grams twice a day during 3 months', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1200', 'city': 'Brussels', 'state': 'Branbant Wallon', 'country': 'Belgium', 'facility': 'Cliniques universitaires Saint Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Thissen Jean-Paul', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}