Clinical trial NCT03875898: Bread Daily Intake Enriched With Mix Fibers in Metabolic Subjects: Intestinal Microbiota and Metabolic Profile Impact
Official title: Study of the Impact of Daily Bread Consumption Enriched With a Fibre Mix on Intestinal Microbiota and Metabolic Profile in Subjects at Metabolic Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Obesity, Metabolically
Lead sponsor: Bridor
Sponsor class: INDUSTRY
First posted: 2019-03-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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)


Eligibility criteria: 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)

Primary outcomes:
measure: Change from Baseline Intestinal microbiota composition at eight weeks
timeFrame: baseline and eight weeks
Secondary outcomes:
measure: Change from baseline fasting and post prandial plasma glucose at eight weeks
timeFrame: baseline and eight weeks
measure: Change from baseline fasting and post prandial plasma Insulin at eight weeks
timeFrame: baseline and eight weeks
measure: Change from baseline fasting and post prandial plasma triglycerides at eight weeks
timeFrame: baseline and eight weeks
measure: Change from baseline fasting and post prandial plasma non-esterified fatty acids at eight weeks
timeFrame: baseline and eight weeks
measure: Change from baseline fasting plasma lipids (cholesterol total, cholesterol HDL and LDL) at eight weeks
timeFrame: baseline and eight weeks
measure: Change from baseline C-Reactive Protein at eight weeks
timeFrame: baseline and eight weeks
measure: Change from baseline MDA (Malon Di Aldehyde) at eight weeks
timeFrame: baseline and eight weeks
measure: Change from baseline Acetylated ghrelin at eight weeks
timeFrame: baseline and eight weeks
measure: Change from baseline Satiety evaluation at eight weeks
timeFrame: baseline and eight weeks
measure: Change from baseline Body composition at eight weeks
timeFrame: baseline and eight weeks
measure: Change from Baseline Resting Energy Expenditure at eight weeks
timeFrame: baseline and eight weeks
measure: Change from Baseline substrate oxydation at eight weeks
timeFrame: baseline and eight weeks
measure: Change from baseline fibre intake at eight weeks
timeFrame: baseline and eight weeks
measure: Change from baseline Gastrointestinal tolerance symptoms at eight weeks.
timeFrame: baseline and eight weeks
measure: Change from baseline stool consistency at eight weeks
timeFrame: baseline and eight weeks
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Centre de Recherche en Nutrition Humaine Rhône-Alpes
Study officials:
affiliation: Centre de Recherche en Nutrition Rhône-Alpes
name: Martine LAVILLE, MD, Phd
role: PRINCIPAL_INVESTIGATOR
References: