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

Study of the Impact of Daily Bread Consumption Enriched With a Fibre Mix on Intestinal Microbiota and Metabolic Profile in Subjects at Metabolic Risk

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)

Study Overview

• Status: Completed
• Conditions: Healthy Obesity, Metabolically
• Intervention / Treatment: Other: 150 g bread fortified (15 g mix fibre); Other: 150 g unfortified bread

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Pierre-Bénite, France
    • Centre de Recherche en Nutrition Humaine Rhône-Alpes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: 150 g bread fortified (15 g mix fibre); Daily consumption of 150g of a bread fortified in fibre mix (15g) during eight weeks.
Placebo Comparator: 150 g unfortified bread; Volunteers will have to consume daily 150 g of an unfortified usual bread during eight weeks	Other: 150 g unfortified bread; Daily consumption of 150g of an usual bread in fibre-unfortified bread during eight weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline fasting and post prandial plasma glucose at eight weeks	Plasma glucose will be measured in the fasting state and in the post-meal period over 7 hours before and after each eight weeks consumption sequence (fibre-fortified bread vs unfortified)	baseline and eight weeks
Change from baseline fasting and post prandial plasma Insulin at eight weeks	Plasma insulin will be measured in the fasting state and in the post-meal period over 7 hours before and after each eight weeks consumption sequence (fibre-fortified bread vs unfortified)	baseline and eight weeks
Change from baseline fasting and post prandial plasma triglycerides at eight weeks	Plasma triglycerides will be measured in the fasting state and in the post-meal period over 7 hours before and after each eight weeks consumption sequence (fibre-fortified bread vs unfortified)	baseline and eight weeks
Change from baseline fasting and post prandial plasma non-esterified fatty acids at eight weeks	Plasma non-esterified fatty acids will be measured in the fasting state and in the post-meal period over 7 hours before and after each eight weeks consumption sequence (fibre-fortified bread vs unfortified)	baseline and eight weeks
Change from baseline fasting plasma lipids (cholesterol total, cholesterol HDL and LDL) at eight weeks	Fasting plasma lipids will be measured before and after each eight weeks consumption sequence (fibre-fortified bread vs unfortified)	baseline and eight weeks
Change from baseline C-Reactive Protein at eight weeks	CRPus will be measured before and after each eight weeks, consumption sequences (fiber-fortified bread vs unfortified)	baseline and eight weeks
Change from baseline MDA (Malon Di Aldehyde) at eight weeks	MDA will be measured before and after each eight weeks consumption sequence (fibre-fortified bread vs unfortified)	baseline and eight weeks
Change from baseline Acetylated ghrelin at eight weeks	Acylated ghrelin will be measured in the fasting state and postprandial period (at 0 and 240 min) before and after each eight weeks consumption sequence (fibre-fortified bread vs unfortified)	baseline and eight weeks
Change from baseline Satiety evaluation at eight weeks	Satiety response will be measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS) (on a 90mm horizontal line; from no sensation of satiety (minimal) to strong sensation of satiety (maximum).	baseline and eight weeks
Change from baseline Body composition at eight weeks	Body composition will be measured with bio-impedancemetry before and after each eight weeks consumption sequence (fibre-fortified bread vs unfortified)	baseline and eight weeks
Change from Baseline Resting Energy Expenditure at eight weeks	Resting Energy Expenditure will be measured with indirect calorimetry before and after each eight weeks consumption sequence (fibre-fortified bread vs unfortified).	baseline and eight weeks
Change from Baseline substrate oxydation at eight weeks	Substrate oxydation (in the postprandial period over 7 hours) will be measured with indirect calorimetry before and after each eight weeks consumption sequence (fibre-fortified bread vs unfortified).	baseline and eight weeks
Change from baseline fibre intake at eight weeks	The volunteers will complete a dietary survey of three days and fibre questionnaire	baseline and eight weeks
Change from baseline Gastrointestinal tolerance symptoms at eight weeks.	Subjective ratings of bloating, nausea, vomiting, abdominal cramping and flatulence will be measured using visual analogue scale (VAS) score (on a 90mm horizontal line; from no symptom (minimal) to serious symptom (maximum).	baseline and eight weeks
Change from baseline stool consistency at eight weeks	Stool consistency by Bristol Stool Chart (type1-7)	baseline and eight weeks

Collaborators and Investigators

• Sponsor: Bridor
• Investigators: Principal Investigator: Martine LAVILLE, MD, Phd, Centre de Recherche en Nutrition Rhône-Alpes

Publications and helpful links

Helpful Links

• website of the clinical investigation center

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2017
• Primary Completion (Actual): November 26, 2018
• Study Completion (Actual): November 26, 2018

Study Registration Dates

• First Submitted: July 13, 2018
• First Submitted That Met QC Criteria: March 13, 2019
• First Posted (Actual): March 15, 2019

Study Record Updates

• Last Update Posted (Actual): March 15, 2019
• Last Update Submitted That Met QC Criteria: March 13, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Metabolically Benign
• Other Study ID Numbers: Bridor

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No