Inulin-type Fructans-rich Vegetables, Obesity, Gut Microbiota

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Inulin

• Registration Number: NCT03852069
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief Summary

The purpose of the study was to evaluate the effect of a diet based on ITF-rich vegetables in combination with purified ITF supplementation on weight management, metabolic alteration and gut microbiota composition. Obese patients were treated for 3 months and several parameters were measured before and after the study period.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Primary Completion: 2018-05
• Study Completion: 2018-05
• Study First Submitted: 2019-02-21
• Study First Submitted QC: 2019-02-21
• Study First Posted: 2019-02-22
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-18
• Last Update Posted: 2020-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• Body mass index > 30 kg/m²
• Caucasian
• Presence of at least one of the following comorbidity : prediabetes, diabetes, dyslipidemia, hypertension, steatosis.

Exclusion Criteria

• Psychiatric problems or use of antipsychotic
• Consumption of antibiotics, pro/prebiotics, fibre dietary supplement, or any molecules that modifies the intestinal transit (<6 weeks)
• Pregnancy in progress or planified within 6 months
• Specific dietary practise (vegetarian, vegan,...)
• Specific dietary treatment (<6 weeks) (e.g. high protein diet)
• Type 1 diabetes
• Excessive alcohol consumption (>3 glasses/day)
• Inconclusive acceptability test (regarding the protocol of the intervention and the vegetables used in the protocol)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	16 g maltodextrin/day + recipes based on vegetables poor in inulin-type fructans
Inulin	Inulin	16 g inulin/day + recipes based on vegetables rich in inulin-type fructans

Primary Outcome Measures

Name	Time	Method
Gut microbiota composition	Month 0 - Month 3	Relative abundance (percent) of bacterial taxa will be assessed by 16S rRNA gene sequencing

Secondary Outcome Measures

Name	Time	Method
Mood and emotional competence	Month 0 - Month 3	Profile of Emotional Competence (PEC, from 0 to 5, higher score associated with better emotional competence).
Dietary intake	Month 0 - Month 3	one-week recall questionnaire to evaluate the dietary intake (macronutrients, caloric intake)
Hepatic fibrosis and/or steatosis	Month 0 - Month 3	controlled attenuation parameter (CAP) by Fibroscan (dB/m)
Cognition	Month 0 - Month 3	computer-based tests of the flexibility, the working memory and the inhibition of participants. The measurements will be the time to complete the task on the computer as well as the number of errors.
Metabolomics	Month 0 - Month 3	metabolomic analysis of biological samples (urine, blood and/or stool)
Physical activity	Month 0 - Month 3	IPAQ questionnaire (The IPAQ long form asks details about the specific types of activities undertaken within the four main domains (leisure time PA, domestic and gardening (yard) activities, work-related PA and transport-related PA). Computation of the total scores for the long form requires summation of the duration (in minutes) and frequency (days) for all the types of activities in all domains. Results allowed us to classify different levels of PA proposed by the questionnaire (total, low-moderate or high-intensity physical activities)
Blood pressure	Month 0 - Month 3	systolic and diastolic blood pressures (mm Hg)
Glucose homeostasis	Month 0 - Month 3	dipeptidyl-peptidase IV activity in the plasma (UI/l)
Lipid homeostasis	Month 0 - Month 3	HLD-Cholesterol, triglycerides, total cholesterol, free fatty acids in the plasma (mg/dl)
Eating behavior	Month 0 - Month 3	Dutch Eating Behaviour Questionnaire (DEBQ).The DEBQ is a 33-items questionnaire assessing 3 distinct behaviour: emotional eating (13 items), external eating (10 items) and restrained eating (10 items). Each item is rated on a 5-point scale. A high score is observed when individual tended to eat more when submitted to emotional and external stimuli (for emotional and external eating subscales) or when he displayed elevated cognitive control on its eating behaviour (for the restrained eating subscale).
Gut peptides	Month 0 - Month 3	Gut peptide (GLP-1, GIP, ghrelin, PP, leptin) multiplex immunoassay (all in pg/ml)
Anthropometry	Month 0 - Month 3	Body composition by CT scan analysis (fat and muscle areas, cm2)
Biomarkers of systemic inflammation	Month 0 - Month 3	Cytokines levels (Il-1β; IL-8; IL-12p70; IL-17a; MCP1; TNFα; IFNγ) by multiplex immunoassay (all in pg/ml)