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

NCT03875898 | Completed

• 1 other identifier: Bridor
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Intestinal microbiota composition at eight weeks

  intestinal microbiota composition will be measured by metagenomic analysis before all interventions, and before and after each eight weeks consumption sequence (fibre-fortified bread vs unfortified)

  baseline and eight weeks

Secondary Outcomes (15)

• Change from baseline fasting and post prandial plasma glucose at eight weeks

  baseline and eight weeks

• Change from baseline fasting and post prandial plasma Insulin at eight weeks

  baseline and eight weeks

• Change from baseline fasting and post prandial plasma triglycerides at eight weeks

  baseline and eight weeks

• Change from baseline fasting and post prandial plasma non-esterified fatty acids at eight weeks

  baseline and eight weeks

• Change from baseline fasting plasma lipids (cholesterol total, cholesterol HDL and LDL) at eight weeks

  baseline and eight weeks

Study Arms (2)

150 g bread fortified (15 g mix fibre)

EXPERIMENTAL

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

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

150 g unfortified bread

PLACEBO COMPARATOR

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

Other: 150 g unfortified bread

Interventions

150 g bread fortified (15 g mix fibre) OTHER

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

150 g bread fortified (15 g mix fibre)

150 g unfortified bread OTHER

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

150 g unfortified bread

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bridor: lead

Study Sites (1)

Centre de Recherche en Nutrition Humaine Rhône-Alpes

Pierre-Bénite, France

Location

Related Links

• website of the clinical investigation center

MeSH Terms

Conditions

Obesity, Metabolically Benign

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Martine LAVILLE, MD, Phd

  Centre de Recherche en Nutrition Rhône-Alpes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Bridor Quality Manager

Study Record Dates

• First Submitted: July 13, 2018
• First Posted: March 15, 2019
• Study Start: June 8, 2017
• Primary Completion: November 26, 2018
• Study Completion: November 26, 2018
• Last Updated: March 15, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)