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

Bridor

Status: Completed

Conditions: Healthy Obesity, Metabolically

Treatments: Other: 150 g unfortified bread; Other: 150 g bread fortified (15 g mix fibre)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03875898

Bridor

Details and patient eligibility

About

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)

Enrollment: 40 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

150 g bread fortified (15 g mix fibre)

Experimental group

Description:

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

Treatment:

Other: 150 g bread fortified (15 g mix fibre)

150 g unfortified bread

Placebo Comparator group

Description:

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

Treatment:

Other: 150 g unfortified bread