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OpenTrials
Completed

NCT Number: NCT03852069

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Inulin

Dietary Supplement

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

Dietary Supplement

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

Primary outcomes

  1. Gut microbiota composition

    Time frame: Month 0 - Month 3

    Relative abundance (percent) of bacterial taxa will be assessed by 16S rRNA gene sequencing

Secondary outcomes

  1. Anthropometry

    Time frame: Month 0 - Month 3

    height (cm)

  2. Anthropometry

    Time frame: Month 0 - Month 3

    weight (kg)

  3. Anthropometry

    Time frame: Month 0 - Month 3

    hip circumference and waist circumference (cm)

  4. Anthropometry

    Time frame: Month 0 - Month 3

    Body mass index (BMI, kg/m2)

  5. Anthropometry

    Time frame: Month 0 - Month 3

    Body composition by bioimpedance analysis (fat mass, fat free mass, kg)

  6. Anthropometry

    Time frame: Month 0 - Month 3

    Body composition by CT scan analysis (fat and muscle areas, cm2)

  7. Blood pressure

    Time frame: Month 0 - Month 3

    systolic and diastolic blood pressures (mm Hg)

  8. Glucose homeostasis

    Time frame: Month 0 - Month 3

    glycemia (mg/dl) (fasted, after an oral glucose tolerance test)

  9. Glucose homeostasis

    Time frame: Month 0 - Month 3

    insulinemia (mU/l) (fasted, after an oral glucose tolerance test)

  10. Glucose homeostasis

    Time frame: Month 0 - Month 3

    C-peptide (pM)

  11. Glucose homeostasis

    Time frame: Month 0 - Month 3

    glycated hemoglobin HbA1c (percent)

  12. Glucose homeostasis

    Time frame: Month 0 - Month 3

    dipeptidyl-peptidase IV activity in the plasma (UI/l)

  13. Lipid homeostasis

    Time frame: Month 0 - Month 3

    HLD-Cholesterol, triglycerides, total cholesterol, free fatty acids in the plasma (mg/dl)

  14. Hepatic fibrosis and/or steatosis

    Time frame: Month 0 - Month 3

    hepatic enzymes in the plasma (AST, ALT, gamma-glutamyl transpeptidase, U/l)

  15. Hepatic fibrosis and/or steatosis

    Time frame: Month 0 - Month 3

    Elasticity by Fibroscan (kPa)

  16. Hepatic fibrosis and/or steatosis

    Time frame: Month 0 - Month 3

    controlled attenuation parameter (CAP) by Fibroscan (dB/m)

  17. Eating behavior

    Time frame: 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.

  18. Eating behavior

    Time frame: 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).

  19. Mood and emotional competence

    Time frame: 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)

  20. Mood and emotional competence

    Time frame: Month 0 - Month 3

    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)

  21. Mood and emotional competence

    Time frame: Month 0 - Month 3

    Profile of Emotional Competence (PEC, from 0 to 5, higher score associated with better emotional competence).

  22. Cognition

    Time frame: 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.

  23. Dietary intake

    Time frame: Month 0 - Month 3

    one-week recall questionnaire to evaluate the dietary intake (macronutrients, caloric intake)

  24. Biomarkers of systemic inflammation

    Time frame: Month 0 - Month 3

    Cytokines levels (Il-1β; IL-8; IL-12p70; IL-17a; MCP1; TNFα; IFNγ) by multiplex immunoassay (all in pg/ml)

  25. Gut peptides

    Time frame: Month 0 - Month 3

    Gut peptide (GLP-1, GIP, ghrelin, PP, leptin) multiplex immunoassay (all in pg/ml)

  26. Metabolomics

    Time frame: Month 0 - Month 3

    metabolomic analysis of biological samples (urine, blood and/or stool)

  27. Physical activity

    Time frame: 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)

Other outcomes

  1. Fecal microbial-derived metabolites

    Time frame: 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

  2. Biomarkers of gut integrity and inflammation

    Time frame: 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

  3. Biomarkers of gut integrity and inflammation

    Time frame: Month 0 - Month 3

    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

  4. Biomarkers of gut integrity and inflammation

    Time frame: Month 0 - Month 3

    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

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Official study title

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

Acronym: Food4Gut

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 22, 2019
Registry last updated
Dec 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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