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

NCT03875898 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-03-15

No results posted yet for this study

Summary

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)

Conditions

  • Healthy Obesity, Metabolically

Interventions

OTHER

150 g bread fortified (15 g mix fibre)

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

OTHER

150 g unfortified bread

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

Sponsors & Collaborators

  • Bridor

    lead INDUSTRY

Principal Investigators

  • Martine LAVILLE, MD, Phd · Centre de Recherche en Nutrition Rhône-Alpes

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-08
Primary Completion
2018-11-26
Completion
2018-11-26

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03875898 on ClinicalTrials.gov