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

Healthy Clinical Trial

— FITABLE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03717311
• Other study ID #: 69HCL18_0143
• Status: Completed
• Phase: N/A
• Start date: November 8, 2018
• Est. completion date: January 31, 2019

Study information

• Verified date: March 2019
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: January 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Nutritional Intervention
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.

Locations

Country	Name	City	State
France	Centre de Recherche en Nutrition Humaine Rhône-Alpes	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 hours
Secondary	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.	24 hours
Secondary	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.	24 hours
Secondary	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	24 hours
Secondary	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	Hour 72
Secondary	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)	24 hours
Secondary	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.	Day -30
Secondary	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)	Day 0
Secondary	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.	Day 0
Secondary	apolipoprotein B48 concentrations in plasma and TGRL	apolipoprotein B48 concentrations in plasma and TGRLby ELISA technique	Day 0
Secondary	TGRL particle sizes	TGRL particle sizes by laser granulometry	Day 0
Secondary	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.	24 hours
Secondary	Stool consistency	Stool consistency by Bristol Stool Chart (type1-7)	one week (at each stool)
Secondary	Stool frequency	By questionnaire	one week
Secondary	Gastro intestinal symptoms	By questionnaires and visual analogue scale (VAS) score (on a 90mm horizontal line; from no symptom (minimal) to serious symptom (maximum).	one week
Secondary	measurement of plasmatic PUFA concentration	Plasma samples will be prepared and analysed by gas-liquid chromatography-	24 hours
Secondary	Metagnomic of gut microbiota	Stool samples will be prepared and analysed by 16SrDBA ilimina sequencing	one week (at each stool)

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