Tolerance Profile of Soluble Fibers in Individuals With Self-perceived GI Sensitivity to Fibers (Tarine)

NCT06877013 | Recruiting

• 1 other identifier: 23REX0061999
• Study Type: interventional
• Target: 173
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the optimal dose of soluble fibers that induces tolerable gastrointestinal symptoms.

Conditions

Population With Self-perceived Gastro-intestinal Sensitivity to Fibers

Keywords

Exploratory; Monocentric; Single blinded; Randomized; Multi-dose; Soluble fibers; Gastro-intestinal sensitivity; Parallel study; Placebo-challenge

Outcome Measures

Primary Outcomes (2)

• Non-tolerance

  Percentage of non-tolerance events as defined by participant dropping out due to digestive symptoms during the 7-day intervention phase

  After 7 days of study product consumption

• Score of the Digestive Symptoms Frequency Questionnaire (DSFQ)

  The absolute change from baseline (run-in) to day 7 of the intervention phase on the total score of the Digestive Symptoms Frequency Questionnaire (DSFQ)

  After 7 days of study product consumption

Secondary Outcomes (17)

• Visual Analog Scale (VAS) score

  After 7 days of study product consumption

• Maximum score of digestive symptoms

  After 7 days of study product consumption

• The time to maximum score of digestive symptoms

  After 7 days of study product consumption

• incremental Area Under Curve (iAUC)

  After 7 days of study product consumption

• Digestive Symptoms Frequency Questionnaire (DSFQ)

  After 7 days of study product consumption

Study Arms (5)

Dose 1

EXPERIMENTAL

8.0g oligosaccharide FODMAP A + 1.6g oligosaccharide FODMAP B

Other: Fiber's mix (among 4 doses)

Dose 2

EXPERIMENTAL

12g oligosaccharide FODMAP A + 2.4g oligosaccharide FODMAP B

Other: Fiber's mix (among 4 doses)

Dose 3

EXPERIMENTAL

16g oligosaccharide FODMAP A + 3.2g oligosaccharide FODMAP B

Other: Fiber's mix (among 4 doses)

Dose 4

EXPERIMENTAL

20g oligosaccharide FODMAP A + 4.0g oligosaccharide FODMAP B

Other: Fiber's mix (among 4 doses)

Placebo

EXPERIMENTAL

8.0 g Dextrose

Other: Placebo challenge

Interventions

Placebo challenge OTHER

2 sachets per day over 7-day challenge

Placebo

Fiber's mix (among 4 doses) OTHER

2 sachets per day over 7-day challenge

Dose 1; Dose 2; Dose 3; Dose 4

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years of age inclusive, and Body Mass Index (BMI) 18.5-29.9 kg/m2 inclusive; who according to the Rome IV fulfil criteria for self-perceived sensitivity to oligosaccharide FODMAP A and B including participants diagnosed with IBS, FBFB, or FBD-U.
• years of age inclusive, and BMI 18.5-29.9 kg/m2 inclusive; who fulfil criteria for self-perceived sensitivity to oligosaccharide FODMAP A and B, not diagnosed with IBS, FB or FBD-U as per Rome IV Criteria but reporting abdominal pain at least once a week AND/OR bloating/distention at least once a week as per ROME IV diagnostic questionnaire.
• Individuals who fully understand the objectives of the study, who are willing to provide consent and agree to follow the protocol of the study.
• Participant is covered by French health insurance.
• Participant agrees to be registered in the national database of participants participating in clinical research.
• Participant is willing and able to complete the electronic Patient Reported Outcomes (ePRO) using a digital device (e.g. smartphone with minimal OS version of IOS 16.6 or android 11 or more recent) having access to internet (web site).
• Female participants must either be postmenopausal for at least 12 months or have undergone specific surgical procedures resulting in sterility (such as hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) or they are using one of the medically approved contraceptive methods listed below from V1 until the end of the study, such as, but not exclusively:
• oral contraception
• intra-uterine device (IUD)
• double barrier method (e.g., condoms and spermicide)
• abstinence, when the opinion of the investigator, their occupation or lifestyle gives efficient evidence that abstinence will be maintained throughout the study and for one month thereafter.

You may not qualify if:

• Individuals who score below 75 or who score 300 or above on the Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) if diagnosed with IBS using the Rome IV criteria.
• Individuals that are diagnosed with any other chronic gastrointestinal or metabolic disease or condition including inflammatory bowel disease, coeliac disease, fistulas or physiological/mechanical gastrointestinal obstruction, diverticulitis, gastric bezoar, radiation enteritis, suspected or known strictures.
• Change of dietary habits within the 4 weeks preceding V1 (e.g., start of a diet rich in fibers) or planned change (e.g., start of a new diet during study participation).
• Individuals with specific and extreme diets (e.g.: strict low-FODMAP, gluten free, high fiber diet, etc.).
• Individuals who anticipate changes to consumption of naturally probiotic/prebiotic containing foods e.g., yogurt with live cultures etc., in the next 2 months.
• Participant who has planned to participate in another clinical study during the period of this study OR participant involved in any other clinical study in the past four weeks.
• Participant with known allergy to any component of the study product(s).
• Individuals receiving any form of treatment likely to interfere with metabolism or dietary habits (e.g., anorexia, weight loss.).
• Participant with any intake of antibiotics or intestinal antiseptics in the previous month (within 30 days) prior to screening visit (V1).
• Individuals with current use of medication with potential central nervous system effects as judged by the investigator.
• Individuals with previous digestive surgery (except for appendectomy performed more than 2 years ago).
• Participants performing strenuous daily exercise for more than 1.5 hours at a time (e.g., intensive daily cardio for more than 1.5 hours).
• Oral disease or medical condition that may impact on hydrogen and methane breath sampling (e.g., gingivitis, halitosis, oral thrush, candidiasis, asthma).
• Participant with any intake of drugs that might modify gastrointestinal function (e.g., regular use of laxatives, anti-diarrheal agents, anti-emetics, prokinetics, proton pump inhibitors (PPIs), NSAIDs, antacids, etc.) or breath function (e.g. aerosol) in the past 8 weeks or, plan to use.
• Individuals who take supplements used to treat bloating: activated charcoal, enzymes (ex: lactase, alpha galactosidase, fructanase).

Sponsors & Collaborators

• Danone Global Research & Innovation Center: lead

Study Sites (1)

CEN experimental

Dijon, France

RECRUITING

Central Study Contacts

Danone Global Research & Innovation Center

CONTACT

+33 (0)1 69 35 70 00; register.clinicalresearchnutricia@danone.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single blinded, Randomized, Parallel group

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: March 14, 2025
• Study Start: November 13, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)