Bread Daily Intake Enriched With Mix Fibers in Metabolic Subjects: Intestinal Microbiota and Metabolic Profile Impact

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-08

Study Completion Date

2018-11-26

Brief Summary

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The level of fibre consumption in France is lower than the national and international recommendations (mean 18.8 g/d for men, 16.4 g/d for women (INCA 2007 Study) instead of 30g/d recommended). Fibre have beneficial effects on health and interact with the intestinal microbiota diversity: a diet fortified with different structure fibres increase of 25 % the dysbiotic intestinal microbiota in obese patient (Cotillard et al, Dietary intervention impact on gut microbial gene richness. Nature, August 2013). The study aim is to evaluate the impact of daily consumption of bread (150 g ) enriched with a mixture of fibres of different structure (15g) during two months on the intestinal microbiota composition in metabolic risk subjects (abdominal overweight or obese) and also, to assess the correlation between the microbiota change and their metabolic profile improvement.It is a mono centric study with a centre in LYON (Centre de Recherche en Nutrition Humaine Rhône-Alpes)

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Detailed Description

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Conditions

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Healthy Obesity, Metabolically

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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150 g bread fortified (15 g mix fibre)

Volunteers will have to consume daily 150 g of a bread instead of usual bread during eight weeks

Group Type EXPERIMENTAL

150 g bread fortified (15 g mix fibre)

Intervention Type OTHER

Daily consumption of 150g of a bread fortified in fibre mix (15g) during eight weeks.

150 g unfortified bread

Volunteers will have to consume daily 150 g of an unfortified usual bread during eight weeks

Group Type PLACEBO_COMPARATOR

150 g unfortified bread

Intervention Type OTHER

Daily consumption of 150g of an usual bread in fibre-unfortified bread during eight weeks

Interventions

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150 g bread fortified (15 g mix fibre)

Daily consumption of 150g of a bread fortified in fibre mix (15g) during eight weeks.

Intervention Type OTHER

150 g unfortified bread

Daily consumption of 150g of an usual bread in fibre-unfortified bread during eight weeks

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Body Mass Index of 25 to 35 kg/m2
* Waist circumference greater than 80 cm for women and than 96 cm for men
* Low level of fibre intake (\<20 g /d) and low level of fibre nature diversity
* Daily bread consumption

Exclusion Criteria

* Bread products allergy or intolerance
* Digestive surgery history except appendicectomy
* Metabolic or gastrointestinal disease history
* Medication that could interfere with glucose and lipid metabolism or intestinal microbiota (for example, no antibiotics within the 3 months before the study)
* Smokers (5 cig/d or more)

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes