Healthy Obesity, MetabolicallyBreathNCT03875898
Bread Daily Intake Enriched With Mix Fibers in Metabolic Subjects: Intestinal Microbiota and Metabolic Profile Impact
A study testing 150 g bread fortified (15 g mix fibre) and 150 g unfortified bread in people with Healthy Obesity, Metabolically, run by Bridor at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Obesity, Metabolically
- What is being tested?
- 150 g bread fortified (15 g mix fibre) and 150 g unfortified bread
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jun 2017to 26 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de Recherche en Nutrition Humaine Rhône-Alpes
Pierre-Bénite
About this study
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
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)
- Conditions
- Healthy Obesity, Metabolically
- Being tested
- 150 g bread fortified (15 g mix fibre), 150 g unfortified bread
- Medical subject headings
- Obesity, Metabolically Benign
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
150 g bread fortified (15 g mix fibre)Other
Daily consumption of 150g of a bread fortified in fibre mix (15g) during eight weeks.
150 g unfortified breadOther
Daily consumption of 150g of an usual bread in fibre-unfortified bread during eight weeks
| Study group | Role | What they receive |
|---|---|---|
| 150 g bread fortified (15 g mix fibre) | Experimental | Volunteers will have to consume daily 150 g of a bread instead of usual bread during eight weeks Receives: Other: 150 g bread fortified (15 g mix fibre) |
| 150 g unfortified bread | Placebo comparator | Volunteers will have to consume daily 150 g of an unfortified usual bread during eight weeks Receives: Other: 150 g unfortified bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: baseline and eight weeks
Secondary outcomes (15)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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).
Measured: baseline and eight weeks
Change from baseline stool consistency at eight weeks
Stool consistency by Bristol Stool Chart (type1-7)
Measured: baseline and eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start8 Jun 2017
- Primary completion26 Nov 2018
- Study completion26 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Obesity, MetabolicallyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bridor
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, DUSSOUS Isabelle, Bridor
- Investigators
- Martine LAVILLE, MD, Phd, Principal investigator, Centre de Recherche en Nutrition Rhône-Alpes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03875898
- Sponsor's protocol ID
- Bridor
- Acronym
- Breath
- Status last verified
- Mar 2019
- First submitted
- 13 Jul 2018
- Last updated
- 15 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03875898
- Acronym / sponsor ID
- Breath / Bridor
- Conditions
- Healthy Obesity, Metabolically
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- BridorIndustry (pharma, biotech, devices)
- Study start
- 8 Jun 2017 (actual)
- Primary completion
- 26 Nov 2018 (actual)
- Study completion
- 26 Nov 2018 (actual)
- First posted
- 15 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 150 g bread fortified (15 g mix fibre) | Experimental | Other: 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 |
| 150 g unfortified bread | Placebo comparator | Other: 150 g unfortified breadVolunteers will have to consume daily 150 g of an unfortified usual bread during eight weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 150 g bread fortified (15 g mix fibre)Daily consumption of 150g of a bread fortified in fibre mix (15g) during eight weeks. | Other | 150 g bread fortified (15 g mix fibre) |
| 150 g unfortified breadDaily consumption of 150g of an usual bread in fibre-unfortified bread during eight weeks | Other | 150 g unfortified bread |
Primary outcome
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)
15 secondary outcomes
Change from baseline fasting and post prandial plasma glucose at eight weeks
Time frame: baseline and eight weeks
Change from baseline fasting and post prandial plasma Insulin at eight weeks
Time frame: baseline and eight weeks
Change from baseline fasting and post prandial plasma triglycerides at eight weeks
Time frame: 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
Change from baseline fasting plasma lipids (cholesterol total, cholesterol HDL and LDL) at eight weeks
Time frame: baseline and eight weeks
Change from baseline C-Reactive Protein at eight weeks
Time frame: baseline and eight weeks
Change from baseline MDA (Malon Di Aldehyde) at eight weeks
Time frame: baseline and eight weeks
Change from baseline Acetylated ghrelin at eight weeks
Time frame: baseline and eight weeks
Change from baseline Satiety evaluation at eight weeks
Time frame: baseline and eight weeks
Change from baseline Body composition at eight weeks
Time frame: baseline and eight weeks
Change from Baseline Resting Energy Expenditure at eight weeks
Time frame: baseline and eight weeks
Change from Baseline substrate oxydation at eight weeks
Time frame: baseline and eight weeks
Change from baseline fibre intake at eight weeks
Time frame: baseline and eight weeks
Change from baseline Gastrointestinal tolerance symptoms at eight weeks.
Time frame: baseline and eight weeks
Change from baseline stool consistency at eight weeks
Time frame: baseline and eight weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2019.
- website of the clinical investigation centerLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martine LAVILLE, MD, Phd principal investigator
Centre de Recherche en Nutrition Rhône-Alpes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 150 g bread fortified (15 g mix fibre) and 150 g unfortified bread in people with Healthy Obesity, Metabolically, run by Bridor at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Intestinal microbiota composition at eight weeks (time frame: baseline and eight weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2019.