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

Civil Hospices of Lyon

Status

Completed

Conditions

Healthy

Treatments

Other: Nutritional Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT03717311

69HCL18_0143

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

Female

Ages

20 to 40 years old

Volunteers

Accepts Healthy Volunteers

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