Obesity
Conditions
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.
Interventions
DIETARY_SUPPLEMENTInulin
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
DIETARY_SUPPLEMENTPlacebo
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
Sponsors
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gut microbiota composition | Month 0 - Month 3 | Relative abundance (percent) of bacterial taxa will be assessed by 16S rRNA gene sequencing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anthropometry | Month 0 - Month 3 | height (cm) |
| Blood pressure | Month 0 - Month 3 | systolic and diastolic blood pressures (mm Hg) |
| Glucose homeostasis | Month 0 - Month 3 | glycemia (mg/dl) (fasted, after an oral glucose tolerance test) |
| Lipid homeostasis | Month 0 - Month 3 | HLD-Cholesterol, triglycerides, total cholesterol, free fatty acids in the plasma (mg/dl) |
| Hepatic fibrosis and/or steatosis | Month 0 - Month 3 | hepatic enzymes in the plasma (AST, ALT, gamma-glutamyl transpeptidase, U/l) |
| Eating behavior | Month 0 - Month 3 | 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. |
| Mood and emotional competence | Month 0 - Month 3 | 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) |
| 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) |
| 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. |
| Dietary intake | Month 0 - Month 3 | one-week recall questionnaire to evaluate the dietary intake (macronutrients, caloric intake) |
| 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) |
| Gut peptides | Month 0 - Month 3 | Gut peptide (GLP-1, GIP, ghrelin, PP, leptin) multiplex immunoassay (all in pg/ml) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Fecal microbial-derived metabolites | Month 0 - Month 3 | 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 |
| Biomarkers of gut integrity and inflammation | Month 0 - Month 3 | 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 |
Outcome results
None listed