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

March 13, 2019 updated by: DUSSOUS Isabelle, Bridor

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Pierre-Bénite, France
        • Centre de recherche en nutrition humaine Rhone-Alpes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from Baseline Intestinal microbiota composition at eight weeks
Time Frame: baseline and 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline fasting and post prandial plasma glucose at eight weeks
Time Frame: baseline and 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
Time Frame: baseline and 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
Time Frame: baseline and 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
Time Frame: baseline and 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
Time Frame: baseline and 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
Time Frame: baseline and 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
Time Frame: baseline and 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
Time Frame: baseline and 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
Time Frame: baseline and 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
Time Frame: baseline and 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
Time Frame: baseline and 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
Time Frame: baseline and 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
Time Frame: baseline and 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.
Time Frame: baseline and 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
Time Frame: baseline and eight weeks
Stool consistency by Bristol Stool Chart (type1-7)
baseline and eight weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bridor

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Martine LAVILLE, MD, Phd, Centre de Recherche en Nutrition Rhône-Alpes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 8, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 26, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 26, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 15, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 15, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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