Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-28 @ 6:22 PM
Study NCT ID:
NCT03540550
Status:
COMPLETED
Last Update Posted:
2018-06-01
First Post:
2018-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of a Diet Based on Inulin-rich Vegetables on Gut Health and Nutritional Behaviour in Healthy Humans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2016-04-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-30', 'studyFirstSubmitDate': '2018-05-08', 'studyFirstSubmitQcDate': '2018-05-28', 'lastUpdatePostDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-04-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gut microbiota composition', 'timeFrame': '33 days', 'description': 'Gut microbiota composition is assessed by 16S rRNA pyrosequencing. This analysis allows to obtain the relative abundance (%) of the different bacterial taxa and OTUs (operational taxonomic units).'}], 'secondaryOutcomes': [{'measure': 'Gut microbiota fermentation in vivo', 'timeFrame': '33 days', 'description': 'Gut microbiota fermentation is assessed in vivo by an hydrogen breath test. After an oral load of purified inulin, the level of expired hydrogen (ppm) is measured.'}, {'measure': 'Gut microbiota fermentation in vitro', 'timeFrame': '14 days', 'description': 'Gut microbiota fermentation is assessed in vitro by the measurement of total gas (ml/g of dry matter) produced from subject feces incubated with inulin-rich substrates.'}, {'measure': 'Gastrointestinal Symptoms', 'timeFrame': '33 days', 'description': 'Gastrointestinal symptoms were assessed by Visual Analogue Scale (horizontal line of 100 mm). Each subject completed seven separate scales, one for each symptom (rumble, burp, bloating, discomfort, nausea, flatulence, cramp), ranging from "no sensation" (0 mm) to "very severe sensation" (100 mm).'}, {'measure': 'Appetite-related feelings', 'timeFrame': '33 days', 'description': 'Appetite-related feelings were assessed by Visual Analogue Scale (horizontal line of 100 mm). Each subject completed seven separate scales, one for each appetite-related feeling (satiety, intention to eat, fullness, sweet envy, very sweet envy, fat envy, salt envy), ranging from "no sensation" (0 mm or 100 mm depending on the feeling) , to "very strong sensation" (0 mm or 100 mm depending on the feeling).'}, {'measure': 'Correlation of gastrointestinal symptoms with gut bacteria', 'timeFrame': '33 days', 'description': 'The levels of gastrointestinal symptoms were correlated (Spearman correlations) with the relative abundance of bacterial taxa and OTUs (operational taxonomic units)'}, {'measure': 'Short chain fatty acids production', 'timeFrame': '14 days', 'description': 'Short chain fatty acids (SCFAs) production was assessed in vitro by the measurement of total SCFAs (mg/g of dry matter) produced from subject feces incubated with inulin-rich substrates.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '31108510', 'type': 'DERIVED', 'citation': 'Hiel S, Bindels LB, Pachikian BD, Kalala G, Broers V, Zamariola G, Chang BPI, Kambashi B, Rodriguez J, Cani PD, Neyrinck AM, Thissen JP, Luminet O, Bindelle J, Delzenne NM. Effects of a diet based on inulin-rich vegetables on gut health and nutritional behavior in healthy humans. Am J Clin Nutr. 2019 Jun 1;109(6):1683-1695. doi: 10.1093/ajcn/nqz001.'}]}, 'descriptionModule': {'briefSummary': 'Inulin-type fructans (ITF) are fermentable dietary fibres that can confer beneficial health effects through changes in the gut microbiota. However, their effect on gut sensitivity and nutritional behaviour is a matter of debate.\n\nThe investigators evaluated, in healthy individuals, the impact of shifting from their usual food habits towards a diet based on the daily consumption of ITF-rich vegetables on gut microbiota, gastro-intestinal symptoms and food-related behaviour.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI between 20 and 25 kg/m²\n* Caucasian ethnicity\n* Hydrogen producers (assessed by hydrogen breath test)\n\nExclusion Criteria:\n\n* Smokers\n* Laxative consumption (\\<4 weeks)\n* Severe intestinal problems\n* Psychiatric problems or use of antipsychotic\n* Consumption of antibiotics, pro/prebiotics, fibre dietary supplement, or any molecules that modifies the intestinal transit (\\<6 weeks)\n* Specific dietary practise (vegetarian, vegan,...)\n* Specific dietary treatment (\\<6 weeks) (e.g. high protein diet)\n* Excessive alcohol consumption (\\>3 glasses/day)\n* Consumption of the following drugs: proton pump inhibitor, antidiabetic drugs, cholesterol lowering drugs\n* Inconclusive acceptability test (regarding the protocol of the intervention and the vegetables used in the protocol)'}, 'identificationModule': {'nctId': 'NCT03540550', 'briefTitle': 'Effects of a Diet Based on Inulin-rich Vegetables on Gut Health and Nutritional Behaviour in Healthy Humans', 'organization': {'class': 'OTHER', 'fullName': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}, 'officialTitle': 'Modification of the Gut Microbiota Following the Consumption of Inulin-rich Vegetables: Effect on Gut Tolerance, Transit, Behaviour and Digestion in Healthy Humans', 'orgStudyIdInfo': {'id': 'B403201627275'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dietary intervention', 'interventionNames': ['Other: Diet based on inulin-rich vegetables']}], 'interventions': [{'name': 'Diet based on inulin-rich vegetables', 'type': 'OTHER', 'description': 'During two weeks, healthy subjects were instructed to adhere to a controlled diet based on ITF-rich vegetables (±15 g ITF/day).', 'armGroupLabels': ['Dietary intervention']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jean-Paul Thissen, Pr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}