AzTrials
AzTrials

HealthyFITABLENCT03717311

BRAN Pilot Study: Metabolic Signature of Wheat Bran Related to Gut Fermentation in Humans

A study testing Nutritional Intervention in people with Healthy, run by Hospices Civils de Lyon at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

It is a pilot study, conducting on 6 healthy women and aiming at defining new biomarkers related to wheat bran fermentation. For this, a breakfast, containing 5 biscuits enriched in 13-C wheat bran (which grown under 13-CO2 enriched atmosphere) is given to the subjects, then a following will be realized on 24h with… Read more about this study

Who is it for?
Ages 20 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Nutritional Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteFrance
Study dates
8 Nov 2018to 31 Jan 2019
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 20 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Subject able to understand the information given to him and having signed the informed consent form.
  • subject having had a medical examination during the selection visit
  • Healthy subject
  • Female gender
  • Age between 20 and 40 years (limits included)
  • No Smoking
Show all 16Show fewer
  • Body mass index between 20 and 25 kg / m2 (limits included).
  • fiber consumer ≥ 18 g / day
  • Do not present any food allergy, nor food intolerance to the products of the study.
  • Having no particular diet (vegetarian, vegan, high protein, etc.)
  • Having a stool frequency ranging from 1 to 2 per day over the last 2 months
  • Absence of pathology detectable by clinical examination and medical examination that may interfere with the evaluation criteria of the study.
  • Sedentary subject or practicing steady regular physical activity during the entire study (maximum 4 hours per week).
  • Accepting to submit to the protocol of the study with a day of hospitalization of 24h
  • Stable weight in the last 3 months (+/- 5% of total body weight)
  • Affiliation to a social security scheme.

Who cannot join

  • General criteria
  • Subject presenting unstable medical or psychological conditions which, according to the investigator, could lead the subject to be non-compliant or uncooperative during the study or could compromise the safety or participation of the subject under study (according to Articles L.1121-6, L.1121-8, L.1121-9 and L1122-1-2 of the Public Health Code).
  • Failure to respect the exclusion period of another study specified in the "National Volunteer File".
  • Major subject under guardianship.
  • Private subject of his liberty by judicial or administrative decision.
  • Subject having exceeded the annual amount of compensation for participation in research protocols.
Show all 37Show fewer
  • Not having a refrigerator and / or freezer (necessary for the conservation of collections of urine and / or stool made at home) Biological criteria
  • Total blood cholesterol> 11 mmol / L or blood triglycerides> 3 mmol / L
  • Fasting blood glucose> 7 mmol / L
  • CRP> 10 mg / L
  • Demonstration of a biological abnormality judged by the investigator to be clinically significant
  • Transaminases (ASAT and ALAT) and gamma GT greater than 1.5 times the upper limit of normal
  • Medical and therapeutic criteria:
  • History of bariatric surgery
  • History of digestive surgery with the exception of appendectomy
  • Subject presenting gastrointestinal disorders such as ulcers, diverticula or inflammatory bowel diseases
  • Diabetes type 1 or 2.
  • Chronic renal failure.
  • Chronic liver failure.
  • known gastroparesis, gastrectomy, colectomy.
  • History of chronic gastrointestinal disease with malabsorption.
  • External pancreatic insufficiency.
  • Known endocrine pathology that can interfere with carbohydrate metabolism (uncontrolled dysthyroidism, acromegaly, hypercorticism, ...).
  • Subject with organic intestinal disease.
  • subject who has undergone antibiotic therapy in the 3 months preceding the study may interfere with transit or intestinal microbiota:
  • Subject treated with a drug that may interfere with carbohydrate metabolism:
  • Corticosteroids.
  • anorectics.
  • High dose gastric bandages.
  • Subject having a concomitant pathology incompatible with the constraints of the protocol or which may interfere with the evaluation of the main criterion.
  • PA systolic not between 100 and 140 mmHg and diastolic not between 50 and 90 mmHg
  • Dieting or wishing to lose weight
  • Pregnant woman or wishing to be pregnant or breastfeeding (interrogation data)
  • Alcoholism or abuse or dependence on another proven drug. Consumption of more than 3 alcoholic beverages per day is considered abusive. An alcoholic beverage is 30 mL of spirits, 120 mL of wine or 330 mL of beer
  • Donation of blood in the 2 months preceding the selection visit
  • Subjects consuming dietary supplements
  • Subjects refusing to follow the dietary instructions on the 3 days preceding the test day

Trial locations and contacts

1 site in 1 country.

France1 site

  • Centre de Recherche en Nutrition Humaine Rhône-Alpes

    Pierre-Bénite

Other trials in France

About this study

Official title: Pilot Study of the Metabolic Signature of 13C-enriched Wheat Bran Linked to Intestinal Fermentation in Humans: Identification of New Biomarkers

It is a pilot study, conducting on 6 healthy women and aiming at defining new biomarkers related to wheat bran fermentation. For this, a breakfast, containing 5 biscuits enriched in 13-C wheat bran (which grown under 13-CO2 enriched atmosphere) is given to the subjects, then a following will be realized on 24h with breath, urine, fecal and blood samples. Analysis will be performed on these samples in order to determine potential biomarkers of fibers consumption to evaluate the metabolic effects of this consumption and to refine the relevance of nutritional recommendation regarding fibers for healthy subjects.

Conditions
Healthy
Being tested
Nutritional Intervention
Keywords
biomarkers, fermentation, labeled wheat bran

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nutritional InterventionOther

    The intervention will be done on 1 day, time during which, each subject will stay at the CRNH. A breakfast containing the fibers will be given to them, then during 24h a following will be done to get fecal, urinary, plasmatic and expiratory samples. Standardized lunch, dinner and collation will be served during the day.

Study groups in NCT03717311
Study groupRoleWhat they receive
13C enriched bran biscuitExperimentalThe volunteers will consume 5 biscuits (100g) enriched with 13C bran with a 200 ml hot beverage in 15 minutes
Receives: Other: Nutritional Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Measurement of the 13-C isotopic enrichment kinetics

    Measurement of the 13-C isotopic enrichment kinetics of plasmatic SCFAs after ingestion of 5 biscuits enriched with the 13C-labeled fiber, on 24h.The concentration and the 13C isotopic enrichment of SCFAs in the plasma will be determined according method and tools described by Ferchaud-Roucher and al, 2006 and Ahmed and el, 2016 at the Analyse center of Mass Spectrometry in Lyon

    Measured: 24 hours

Secondary outcomes (16)

  1. Measurement of the 13-C isotopic enrichment kinetics in CO2 and CH4 from exhaled gases during 24h after fibers ingestion.

    Gases will be taken thanks to the EasySamplerTM Breath Test Kit. The measurements will be done by gas chromatography thanks to a gas analyzer.

    Measured: 24 hours

  2. Measurement of H2 kinetics in the exhaled breath during 24h.

    H2 will be taken thanks to the EasySamplerTM Breath Test Kit. The measurements will be done by gas chromatography thanks to a gas analyzer.

    Measured: 24 hours

  3. Measurement of the 13-C isotopic enrichment kinetics of SCFAs in urines after ingestion of 5 biscuits enriched with the 13C-labeled fiber, on 24h.

    The concentration and the 13C isotopic enrichment of SCFAs in the urine will be determined according method and tools described by Ferchaud-Roucher and al, 2006 and Ahmed and el, 2016 at the Analyse center of Mass Spectrometry in Lyon

    Measured: 24 hours

  4. Measurement of the 13-C isotopic enrichment kinetics of SCFAs in feces after ingestion of 5 biscuits enriched with the 13C-labeled fiber, on 48h or 72h.

    The concentration and the 13C isotopic enrichment of SCFAs in the urine will be determined according method and tools described by Ferchaud-Roucher and al, 2006 and Ahmed and el, 2016 at the Analyse center of Mass Spectrometry in Lyon

    Measured: Hour 72

  5. The appearance kinetic of 13C glucose in the plasma

    Plasma samples will be prepared and analysed by coupling gas chromatography-combustion-isotopic mass spectrometry according to the method used at the CRNH Rhône-Alpes (Sauvinet et al., 2009)

    Measured: 24 hours

  6. The platelets aggregation as cardimetabolic risk marker in the plasma

    An immuno-enzymatic dosage of platelet thromboxan B2, after the chylomicrons (CM) incubation with platelets, will be done. The measurement of platelet aggregation by aggregometry will be done after the CM and collagen stimulated platelet incubation.

    Measured: Day -30

  7. Sphingolipid molecular species concentrations in plasma and TGRL

    Isolation of plasma and triglyceride-rich lipoproteins (TGRL) fractions by ultracentrifugation and measurement by liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS)

    Measured: Day 0

  8. Fatty acids in lipid classes (triglycerides, phospholipids, cholesteryl esters) of plasma and TGRL

    Determination of molar percentages of fatty acids in lipid classes (triglycerides, phospholipids, cholesteryl esters) of plasma and TGRL, following analysis by gas chromatography.

    Measured: Day 0

  9. apolipoprotein B48 concentrations in plasma and TGRL

    apolipoprotein B48 concentrations in plasma and TGRLby ELISA technique

    Measured: Day 0

  10. TGRL particle sizes

    TGRL particle sizes by laser granulometry

    Measured: Day 0

  11. Intensity of gastro-intestinal symptoms thanks to an analogue visual scale (AVS)

    This AVS allows the measurement of 8 gastro-intestinal symptoms intensity, often described after fibers consumption on a 100 mm scale.

    Measured: 24 hours

  12. Stool consistency

    Stool consistency by Bristol Stool Chart (type1-7)

    Measured: one week (at each stool)

  13. Stool frequency

    By questionnaire

    Measured: one week

  14. Gastro intestinal symptoms

    By questionnaires and visual analogue scale (VAS) score (on a 90mm horizontal line; from no symptom (minimal) to serious symptom (maximum).

    Measured: one week

  15. measurement of plasmatic PUFA concentration

    Plasma samples will be prepared and analysed by gas-liquid chromatography-

    Measured: 24 hours

  16. Metagnomic of gut microbiota

    Stool samples will be prepared and analysed by 16SrDBA ilimina sequencing

    Measured: one week (at each stool)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2018
  2. Study start8 Nov 2018
  3. Primary completion31 Jan 2019
  4. Study completion31 Jan 2019

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03717311
Sponsor's protocol ID
69HCL18_0143
Acronym
FITABLE
Status last verified
Aug 2025
First submitted
11 Jul 2018
Last updated
3 Sep 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Meiller L, Sauvinet V, Breyton AE, Ranaivo H, Machon C, Mialon A, Meynier A, Bischoff SC, Walter J, Neyrinck AM, Laville M, Delzenne NM, Vinoy S, Nazare JA. Metabolic signature of 13C-labeled wheat bran consumption related to gut fermentation in humans: a pilot study. Eur J Nutr. 2023 Sep;62(6):2633-2648. doi: 10.1007/s00394-023-03161-5. Epub 2023 May 24.

    PubMed 37222787

Questions about this trial

What is this clinical trial studying?

A study testing Nutritional Intervention in people with Healthy, run by Hospices Civils de Lyon 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 16 inclusion and 37 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 3 Sep 2025. 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. 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?

Measurement of the 13-C isotopic enrichment kinetics (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03717311, which also lists 1 linked publication.

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 3 Sep 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in