Centre de Recherche en Nutrition Humaine Rhône-Alpes
Pierre-Bénite, France
NCT Number: NCT03717311
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.
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Notify Me20 year–40 year
Female
Interventional
Not applicable
Pierre-Bénite, France
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
General criteria
Medical and therapeutic criteria:
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.
Time frame: 24 hours
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
Time frame: 24 hours
Gases will be taken thanks to the EasySamplerTM Breath Test Kit. The measurements will be done by gas chromatography thanks to a gas analyzer.
Time frame: 24 hours
H2 will be taken thanks to the EasySamplerTM Breath Test Kit. The measurements will be done by gas chromatography thanks to a gas analyzer.
Time frame: 24 hours
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
Time frame: Hour 72
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
Time frame: 24 hours
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)
Time frame: Day -30
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.
Time frame: Day 0
Isolation of plasma and triglyceride-rich lipoproteins (TGRL) fractions by ultracentrifugation and measurement by liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS)
Time frame: Day 0
Determination of molar percentages of fatty acids in lipid classes (triglycerides, phospholipids, cholesteryl esters) of plasma and TGRL, following analysis by gas chromatography.
Time frame: Day 0
apolipoprotein B48 concentrations in plasma and TGRLby ELISA technique
Time frame: Day 0
TGRL particle sizes by laser granulometry
Time frame: 24 hours
This AVS allows the measurement of 8 gastro-intestinal symptoms intensity, often described after fibers consumption on a 100 mm scale.
Time frame: one week (at each stool)
Stool consistency by Bristol Stool Chart (type1-7)
Time frame: one week
By questionnaire
Time frame: one week
By questionnaires and visual analogue scale (VAS) score (on a 90mm horizontal line; from no symptom (minimal) to serious symptom (maximum).
Time frame: 24 hours
Plasma samples will be prepared and analysed by gas-liquid chromatography-
Time frame: one week (at each stool)
Stool samples will be prepared and analysed by 16SrDBA ilimina sequencing
Hospices Civils de Lyon
Other
Pilot Study of the Metabolic Signature of 13C-enriched Wheat Bran Linked to Intestinal Fermentation in Humans: Identification of New Biomarkers
Acronym: FITABLE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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