Bread Daily Intake Enriched With Mix Fibers in Metabolic Subjects: Intestinal Microbiota and Metabolic Profile Impact (Breath)
Primary Purpose
Healthy Obesity, Metabolically
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
150 g bread fortified (15 g mix fibre)
150 g unfortified bread
Sponsored by
About this trial
This is an interventional basic science trial for Healthy Obesity, Metabolically
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)
Sites / Locations
- Centre de Recherche en Nutrition Humaine Rhône-Alpes
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
150 g bread fortified (15 g mix fibre)
150 g unfortified bread
Arm Description
Volunteers will have to consume daily 150 g of a bread instead of usual bread during eight weeks
Volunteers will have to consume daily 150 g of an unfortified usual bread during eight weeks
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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)
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)
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)
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)
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)
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)
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)
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)
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).
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)
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).
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).
Change from baseline fibre intake at eight weeks
The volunteers will complete a dietary survey of three days and fibre questionnaire
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).
Change from baseline stool consistency at eight weeks
Stool consistency by Bristol Stool Chart (type1-7)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03875898
Brief Title
Bread Daily Intake Enriched With Mix Fibers in Metabolic Subjects: Intestinal Microbiota and Metabolic Profile Impact
Acronym
Breath
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
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
June 8, 2017 (Actual)
Primary Completion Date
November 26, 2018 (Actual)
Study Completion Date
November 26, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bridor
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Obesity, Metabolically
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
150 g bread fortified (15 g mix fibre)
Arm Type
Experimental
Arm Description
Volunteers will have to consume daily 150 g of a bread instead of usual bread during eight weeks
Arm Title
150 g unfortified bread
Arm Type
Placebo Comparator
Arm Description
Volunteers will have to consume daily 150 g of an unfortified usual bread during eight weeks
Intervention Type
Other
Intervention Name(s)
150 g bread fortified (15 g mix fibre)
Intervention Description
Daily consumption of 150g of a bread fortified in fibre mix (15g) during eight weeks.
Intervention Type
Other
Intervention Name(s)
150 g unfortified bread
Intervention Description
Daily consumption of 150g of an usual bread in fibre-unfortified bread during eight weeks
Primary Outcome Measure Information:
Title
Change from Baseline Intestinal microbiota composition at eight weeks
Description
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)
Time Frame
baseline and eight weeks
Secondary Outcome Measure Information:
Title
Change from baseline fasting and post prandial plasma glucose at eight weeks
Description
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)
Time Frame
baseline and eight weeks
Title
Change from baseline fasting and post prandial plasma Insulin at eight weeks
Description
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)
Time Frame
baseline and eight weeks
Title
Change from baseline fasting and post prandial plasma triglycerides at eight weeks
Description
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)
Time Frame
baseline and eight weeks
Title
Change from baseline fasting and post prandial plasma non-esterified fatty acids at eight weeks
Description
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)
Time Frame
baseline and eight weeks
Title
Change from baseline fasting plasma lipids (cholesterol total, cholesterol HDL and LDL) at eight weeks
Description
Fasting plasma lipids will be measured before and after each eight weeks consumption sequence (fibre-fortified bread vs unfortified)
Time Frame
baseline and eight weeks
Title
Change from baseline C-Reactive Protein at eight weeks
Description
CRPus will be measured before and after each eight weeks, consumption sequences (fiber-fortified bread vs unfortified)
Time Frame
baseline and eight weeks
Title
Change from baseline MDA (Malon Di Aldehyde) at eight weeks
Description
MDA will be measured before and after each eight weeks consumption sequence (fibre-fortified bread vs unfortified)
Time Frame
baseline and eight weeks
Title
Change from baseline Acetylated ghrelin at eight weeks
Description
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)
Time Frame
baseline and eight weeks
Title
Change from baseline Satiety evaluation at eight weeks
Description
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).
Time Frame
baseline and eight weeks
Title
Change from baseline Body composition at eight weeks
Description
Body composition will be measured with bio-impedancemetry before and after each eight weeks consumption sequence (fibre-fortified bread vs unfortified)
Time Frame
baseline and eight weeks
Title
Change from Baseline Resting Energy Expenditure at eight weeks
Description
Resting Energy Expenditure will be measured with indirect calorimetry before and after each eight weeks consumption sequence (fibre-fortified bread vs unfortified).
Time Frame
baseline and eight weeks
Title
Change from Baseline substrate oxydation at eight weeks
Description
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).
Time Frame
baseline and eight weeks
Title
Change from baseline fibre intake at eight weeks
Description
The volunteers will complete a dietary survey of three days and fibre questionnaire
Time Frame
baseline and eight weeks
Title
Change from baseline Gastrointestinal tolerance symptoms at eight weeks.
Description
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).
Time Frame
baseline and eight weeks
Title
Change from baseline stool consistency at eight weeks
Description
Stool consistency by Bristol Stool Chart (type1-7)
Time Frame
baseline and eight weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martine LAVILLE, MD, Phd
Organizational Affiliation
Centre de Recherche en Nutrition Rhône-Alpes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de Recherche en Nutrition Humaine Rhône-Alpes
City
Pierre-Bénite
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.crnh-rhone-alpes.fr
Description
website of the clinical investigation center
Learn more about this trial
Bread Daily Intake Enriched With Mix Fibers in Metabolic Subjects: Intestinal Microbiota and Metabolic Profile Impact
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