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

Study Overview
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Brief Summary
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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.

Official Title
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Impact of a Diet Rich in Inulin-type Fructans Combined With Inulin Supplementation on Gut Microbiota Composition and Metabolic Parameters in Obese Patients

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: Inulin
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>16 g maltodextrin/day + recipes based on vegetables poor in inulin-type fructans | Dietary Supplement: Placebo<br>* Patient receive maltodextrin as dietary supplement (16g/d) in combination with dietary advice to restrict caloric intake and to enhance the consumption of vegetables poor in inulin<br>|
| Experimental: Inulin<br>16 g inulin/day + recipes based on vegetables rich in inulin-type fructans | Dietary Supplement: Inulin<br>* Patient receive inulin as dietary supplement (16g/d) in combination with dietary advice to restrict caloric intake and to enhance the consumption of inulin-rich vegetables<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gut microbiota composition | Relative abundance (percent) of bacterial taxa will be assessed by 16S rRNA gene sequencing | Month 0 - Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anthropometry | height (cm) | Month 0 - Month 3 | 
| Anthropometry | weight (kg) | Month 0 - Month 3 | 
| Anthropometry | hip circumference and waist circumference (cm) | Month 0 - Month 3 | 
| Anthropometry | Body mass index (BMI, kg/m2) | Month 0 - Month 3 | 
| Anthropometry | Body composition by bioimpedance analysis (fat mass, fat free mass, kg) | Month 0 - Month 3 | 
| Anthropometry | Body composition by CT scan analysis (fat and muscle areas, cm2) | Month 0 - Month 3 | 
| Blood pressure | systolic and diastolic blood pressures (mm Hg) | Month 0 - Month 3 | 
| Glucose homeostasis | glycemia (mg/dl) (fasted, after an oral glucose tolerance test) | Month 0 - Month 3 | 
| Glucose homeostasis | insulinemia (mU/l) (fasted, after an oral glucose tolerance test) | Month 0 - Month 3 | 
| Glucose homeostasis | C-peptide (pM) | Month 0 - Month 3 | 
| Glucose homeostasis | glycated hemoglobin HbA1c (percent) | Month 0 - Month 3 | 
| Glucose homeostasis | dipeptidyl-peptidase IV activity in the plasma (UI/l) | Month 0 - Month 3 | 
| Lipid homeostasis | HLD-Cholesterol, triglycerides, total cholesterol, free fatty acids in the plasma (mg/dl) | Month 0 - Month 3 | 
| Hepatic fibrosis and/or steatosis | hepatic enzymes in the plasma (AST, ALT, gamma-glutamyl transpeptidase, U/l) | Month 0 - Month 3 | 
| Hepatic fibrosis and/or steatosis | Elasticity by Fibroscan (kPa) | Month 0 - Month 3 | 
| Hepatic fibrosis and/or steatosis | controlled attenuation parameter (CAP) by Fibroscan (dB/m) | Month 0 - Month 3 | 
| Eating behavior | Questionnaire for Eating Disorders Diagnosis (Q-EDD). The Q-EDD is a 50-items questionnaire based on Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV allowing the psychologist to diagnose eating disorders (anorexia nervosa, bulimia, binge eating), there is no quantitative result. | Month 0 - Month 3 | 
| Eating behavior | 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). | Month 0 - Month 3 | 
| Mood and emotional competence | Positive and Negative Affect Schedule (PANAS, two subscale - positive and negative - from 10 to 50, higher score associated with higher positive and negative emotion respectively) | Month 0 - Month 3 | 
| Mood and emotional competence | Scale of Positive and Negative Experience (SPANE, two subscale - positive and negative - from 6 to 30, higher score associated with higher positive and negative emotion respectively) | Month 0 - Month 3 | 
| Mood and emotional competence | Profile of Emotional Competence (PEC, from 0 to 5, higher score associated with better emotional competence). | Month 0 - Month 3 | 
| Cognition | 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. | Month 0 - Month 3 | 
| Dietary intake | one-week recall questionnaire to evaluate the dietary intake (macronutrients, caloric intake) | Month 0 - Month 3 | 
| Biomarkers of systemic inflammation | Cytokines levels (Il-1β; IL-8; IL-12p70; IL-17a; MCP1; TNFα; IFNγ) by multiplex immunoassay (all in pg/ml) | Month 0 - Month 3 | 
| Gut peptides | Gut peptide (GLP-1, GIP, ghrelin, PP, leptin) multiplex immunoassay (all in pg/ml) | Month 0 - Month 3 | 
| Metabolomics | metabolomic analysis of biological samples (urine, blood and/or stool) | Month 0 - Month 3 | 
| Physical activity | 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) | Month 0 - Month 3 |