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

Study Overview
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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)

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

Conditions
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Healthy Obesity, Metabolically

Intervention / Treatment
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* Other: 150 g bread fortified (15 g mix fibre)
* Other: 150 g unfortified bread


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |