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

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Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status

Completed

Conditions

Obesity

Treatments

Dietary Supplement: Placebo
Dietary Supplement: Inulin

Study type

Interventional

Funder types

Other

Identifiers

NCT03852069
B403201422056

Details and patient eligibility

About

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.

Enrollment

106 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

106 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
16 g maltodextrin/day + recipes based on vegetables poor in inulin-type fructans
Treatment:
Dietary Supplement: Placebo
Inulin
Experimental group
Description:
16 g inulin/day + recipes based on vegetables rich in inulin-type fructans
Treatment:
Dietary Supplement: Inulin

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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