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

Obesity Clinical Trial

— Food4Gut  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03852069
• Other study ID #: B403201422056
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: May 2018

Study information

• Verified date: December 2020
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• Inulin
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
• Placebo
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

References & Publications (2)

Hiel S, Gianfrancesco MA, Rodriguez J, Portheault D, Leyrolle Q, Bindels LB, Gomes da Silveira Cauduro C, Mulders MDGH, Zamariola G, Azzi AS, Kalala G, Pachikian BD, Amadieu C, Neyrinck AM, Loumaye A, Cani PD, Lanthier N, Trefois P, Klein O, Luminet O, Bi — View Citation

Leyrolle Q, Cserjesi R, Mulders MDGH, Zamariola G, Hiel S, Gianfrancesco MA, Rodriguez J, Portheault D, Amadieu C, Leclercq S, Bindels LB, Neyrinck AM, Cani PD, Karkkainen O, Haninheva K, Lanthier N, Trefois P, Paquot N, Cnop M, Thissen JP, Klein O, Lumin — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fecal microbial-derived metabolites	Long and short chain fatty acid and bile acid profiles (ng/mg feces or percent) considered as exploratory analyses not initially scheduled in the study but performed in the context of the FiberTAG project. Before inclusion of the study, all participants provided written informed consent stipulating that any research outside the context performed in the future could only be conducted after approval by an ethics committee. We obtained agreement from the ethical committee of Saint-Luc for those exploratory analyses	Month 0 - Month 3
Other	Biomarkers of gut integrity and inflammation	Fecal zonulin (ng/mg feces) considered as exploratory analyses not initially scheduled in the study but performed in the context of the FiberTAG project. Before inclusion of the study, all participants provided written informed consent stipulating that any research outside the context performed in the future could only be conducted after approval by an ethics committee. We obtained agreement from the ethical committee of Saint-Luc for those exploratory analyses	Month 0 - Month 3
Other	Biomarkers of gut integrity and inflammation	fecal albumin (ng/mg feces) considered as exploratory analyses not initially scheduled in the study but performed in the context of the FiberTAG project. Before inclusion of the study, all participants provided written informed consent stipulating that any research outside the context performed in the future could only be conducted after approval by an ethics committee. We obtained agreement from the ethical committee of Saint-Luc for those exploratory analyses	Month 0 - Month 3
Other	Biomarkers of gut integrity and inflammation	fecal calprotectin (ng/mg feces) considered as exploratory analyses not initially scheduled in the study but performed in the context of the FiberTAG project. Before inclusion of the study, all participants provided written informed consent stipulating that any research outside the context performed in the future could only be conducted after approval by an ethics committee. We obtained agreement from the ethical committee of Saint-Luc for those exploratory analyses	Month 0 - Month 3
Primary	Gut microbiota composition	Relative abundance (percent) of bacterial taxa will be assessed by 16S rRNA gene sequencing	Month 0 - Month 3
Secondary	Anthropometry	height (cm)	Month 0 - Month 3
Secondary	Anthropometry	weight (kg)	Month 0 - Month 3
Secondary	Anthropometry	hip circumference and waist circumference (cm)	Month 0 - Month 3
Secondary	Anthropometry	Body mass index (BMI, kg/m2)	Month 0 - Month 3
Secondary	Anthropometry	Body composition by bioimpedance analysis (fat mass, fat free mass, kg)	Month 0 - Month 3
Secondary	Anthropometry	Body composition by CT scan analysis (fat and muscle areas, cm2)	Month 0 - Month 3
Secondary	Blood pressure	systolic and diastolic blood pressures (mm Hg)	Month 0 - Month 3
Secondary	Glucose homeostasis	glycemia (mg/dl) (fasted, after an oral glucose tolerance test)	Month 0 - Month 3
Secondary	Glucose homeostasis	insulinemia (mU/l) (fasted, after an oral glucose tolerance test)	Month 0 - Month 3
Secondary	Glucose homeostasis	C-peptide (pM)	Month 0 - Month 3
Secondary	Glucose homeostasis	glycated hemoglobin HbA1c (percent)	Month 0 - Month 3
Secondary	Glucose homeostasis	dipeptidyl-peptidase IV activity in the plasma (UI/l)	Month 0 - Month 3
Secondary	Lipid homeostasis	HLD-Cholesterol, triglycerides, total cholesterol, free fatty acids in the plasma (mg/dl)	Month 0 - Month 3
Secondary	Hepatic fibrosis and/or steatosis	hepatic enzymes in the plasma (AST, ALT, gamma-glutamyl transpeptidase, U/l)	Month 0 - Month 3
Secondary	Hepatic fibrosis and/or steatosis	Elasticity by Fibroscan (kPa)	Month 0 - Month 3
Secondary	Hepatic fibrosis and/or steatosis	controlled attenuation parameter (CAP) by Fibroscan (dB/m)	Month 0 - Month 3
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Mood and emotional competence	Profile of Emotional Competence (PEC, from 0 to 5, higher score associated with better emotional competence).	Month 0 - Month 3
Secondary	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
Secondary	Dietary intake	one-week recall questionnaire to evaluate the dietary intake (macronutrients, caloric intake)	Month 0 - Month 3
Secondary	Biomarkers of systemic inflammation	Cytokines levels (Il-1ß; IL-8; IL-12p70; IL-17a; MCP1; TNFa; IFN?) by multiplex immunoassay (all in pg/ml)	Month 0 - Month 3
Secondary	Gut peptides	Gut peptide (GLP-1, GIP, ghrelin, PP, leptin) multiplex immunoassay (all in pg/ml)	Month 0 - Month 3
Secondary	Metabolomics	metabolomic analysis of biological samples (urine, blood and/or stool)	Month 0 - Month 3
Secondary	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