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Scientists use labeled wheat bran to uncover gut secrets

NCT ID NCT03717311

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This pilot study gave 6 healthy women a breakfast containing wheat bran with a special carbon label (13C) to track how it is fermented in the gut. Over 24 hours, researchers collected breath, urine, blood, and stool samples to measure breakdown products. The goal is to identify new biomarkers that reflect fiber digestion, which could lead to better dietary advice in the future.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
13C-enriched wheat bran
What this could lead to
If successful, this could help develop simple tests to measure how well people digest fiber, improving dietary recommendations.
What could go wrong
This is a very small pilot study with only 6 participants, so results may not apply to everyone. It is designed to find markers, not to test a treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

6 people

The number who actually took part.

Started

Nov 2018

Finished

Jan 2019

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 to 40 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 * 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. Exclusion Criteria: 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. * 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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Centre de Recherche en Nutrition Humaine Rhône-Alpes

    Pierre-Bénite, France

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