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Inulin-type Fructans-rich Vegetables, Obesity, Gut Microbiota (Food4Gut)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03852069
Recruitment Status : Completed
First Posted : February 22, 2019
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Inulin Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : January 2016
Actual Primary Completion Date : May 2018
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Inulin

Arm Intervention/treatment
Placebo Comparator: Placebo
16 g maltodextrin/day + recipes based on vegetables poor in inulin-type fructans
Dietary Supplement: Placebo
Patient receive maltodextrin as dietary supplement (16g/d) in combination with dietary advice to enhance the consumption of vegetables poor in inulin

Experimental: Inulin
16 g inulin/day + recipes based on vegetables rich in inulin-type fructans
Dietary Supplement: Inulin
Patient receive Inulin as dietary supplement (16g/d) in combination with dietary advice to enhance the consumption of inulin-rich vegetables




Primary Outcome Measures :
  1. Gut microbiota composition [ Time Frame: Month 0 - Month 3 ]
    Relative abundance (%) of bacterial taxa will be assessed by 16S rRNA gene sequencing



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03852069


Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
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Principal Investigator: Jean-Paul Thissen, Pr. Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT03852069    
Other Study ID Numbers: B403201422056
First Posted: February 22, 2019    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms