Not Yet RecruitingNot Applicable

Impact of Dietary Fibre Supplementation on Gut Symptoms in Healthy Participants

Finland28 participantsStarted 2026-08-17

Plain-language summary

Fibres found in food are mainly carbohydrates that are not broken down or absorbed during human digestion but instead pass to the colon to be fermented by microbes. Gases produced during bacterial fermentation (hydrogen, methane, and carbon dioxide), can cause unpleasant gastrointestinal symptoms in some individuals, such as bloating, flatulence, and stomach pain. Gas production varies between individuals and is influenced by the chemical structure of dietary fibres, the gut microbes' ability to ferment fibre, intestinal pH, and the transit time of intestinal contents. This randomized clinical trial in healthy adults will investigate how individual variations in the microbiome influence the level of gastrointestinal (GI) symptoms induced by different fibre types during short-term exposure.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * healthy male and female * aged 18-65 years * experience gastrointestinal discomfort during or after eating * willing to commit to the 6-week study period and follow the study schedule. Exclusion Criteria: * Body mass index ≤ 18.5 or ≥ 35 kg/m². * Inflammatory bowel diseases, irritable bowel syndrome (IBS), celiac disease, endocrine or lipid metabolism disorders, liver or kidney diseases, cancer within the past 5 years, eating disorders. * Medication for gastrointestinal symptoms, bowel function, diabetes, or hypercholesterolemia. * Regular or recent use of antibiotics (within the last 3 months). * Food allergies to the ingredients of the study products. * Heavy, long-duration exercise several times a week. * Smoking, use of snus or nicotine pouches. * Planned or ongoing pregnancy or breastfeeding. * In addition, the site-specific principal investigator may exclude a person due to any illness, medication, or factor they deem relevant for the participant's health and safety or for the conduct of the study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Intensity of gastrointestinal symptoms, total score

Timeframe: 6 weeks Differences between the fibre periods and fibre periods and run-in period will be compared.

Intensity of stomach/ abdominal pain

Timeframe: 6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.

Intensity of bloating

Timeframe: 6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.

Intensity of stomach cramps

Timeframe: 6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared

Intensity of flatulence

Timeframe: 6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.

Intensity of borborygmus

Timeframe: 6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.

Trial details

NCT IDNCT07587424

SponsorUniversity of Helsinki

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-30

Contact for this trial

Anne-Maria Pajari, Professor

+358294158203 anne-maria.pajari@helsinki.fi

View on ClinicalTrials.gov More Gastrointestinal Symptoms trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Intensity of gastrointestinal symptoms, total score

Timeframe: 6 weeks Differences between the fibre periods and fibre periods and run-in period will be compared.

Intensity of stomach/ abdominal pain

Timeframe: 6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.

Intensity of bloating

Timeframe: 6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.

Intensity of stomach cramps

Timeframe: 6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared

Intensity of flatulence

Timeframe: 6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.

Intensity of borborygmus

Timeframe: 6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.