NCT03717311

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 24, 2018

Completed
15 days until next milestone

Study Start

First participant enrolled

November 8, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
Last Updated

September 3, 2025

Status Verified

August 1, 2025

Enrollment Period

3 months

First QC Date

July 11, 2018

Last Update Submit

August 26, 2025

Conditions

Healthy

Keywords

biomarkersfermentationlabeled wheat bran

Outcome Measures

Primary Outcomes (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

    24 hours

Secondary Outcomes (16)

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

    24 hours

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

    24 hours

  • 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.

    24 hours

  • 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.

    Hour 72

  • The appearance kinetic of 13C glucose in the plasma

    24 hours

  • +11 more secondary outcomes

Study Arms (1)

13C enriched bran biscuit

EXPERIMENTAL

The volunteers will consume 5 biscuits (100g) enriched with 13C bran with a 200 ml hot beverage in 15 minutes

Other: Nutritional Intervention

Interventions

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.

13C enriched bran biscuit

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)
  • +1 more criteria

You may not qualify if:

  • 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).
  • 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
  • +21 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de Recherche en Nutrition Humaine Rhône-Alpes

Pierre-Bénite, France

Location

Related Publications (1)

  • 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.

    PMID: 37222787BACKGROUND

Related Links

Study Officials

  • Martine LAVILLE, MD

    Centre de Recherche en Nutrition Humaine Rhône-Alpes

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2018

First Posted

October 24, 2018

Study Start

November 8, 2018

Primary Completion

January 31, 2019

Study Completion

January 31, 2019

Last Updated

September 3, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)