Impact of Dietary Fibre Supplementation on Gut Symptoms in Healthy Participants

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Helsinki

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Crossover

Treatments tested in this trial

  • cellulose

    Dietary supplement

    Microcrystalline cellulose; daily dose of fibre from the study product 20 g for females and 25 g for males on 4 consecutive days

  • Oat fibre

    Dietary supplement

    Oat bran-based fibre product; daily dose of fibre from the study product 20 g for females and 25 g for males on 4 consecutive days

  • Rye fibre

    Dietary supplement

    Rye bran-based fibre product; daily dose of fibre from the study product 20 g for females and 25 g for males on 4 consecutive days

Treatment groups

28 Participants
are divided into 3 treatment groups
Group A: CelluloseExperimental treatment 1 intervention
Group B: Oat fibreExperimental treatment 1 intervention
Group C: Rye fibreExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Intensity of gastrointestinal symptoms, total score

The composite score of the intensity of individual gastrointestinal symptoms reported on a VAS scale by the participants.

Time frame
6 weeks Differences between the fibre periods and fibre periods and run-in period will be compared.
2

Intensity of stomach/ abdominal pain

Intensity of experienced stomach/ abdominal pain reported on a VAS scale from zero (no pain) to 100 (very intense pain) by the participants on daily basis.

Time frame
6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.
3

Intensity of bloating

Intensity of experienced bloatingreported on a VAS scale from zero (no symptoms) to 100 (very intense symptoms) by the participants on daily basis.

Time frame
6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.
4

Intensity of stomach cramps

Intensity of experienced stomach cramps reported on a VAS scale from zero (no pain) to 100 (very intense pain) by the participants on daily basis.

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

Secondary outcomes

1

Composition and function of gut microbiome

Microbiota-related analyses of the collected stool samples are carried out using DNA-based methods

Time frame
6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.
2

Number of bowel movements

Number of bowel movements reported by participants on daily basis using a mobile app.

Time frame
6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.
3

Breath gases

Hydrogen and methane measured from exhaled breath samples during run-in and fibre periods.

Time frame
6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.
4

Fecal and blood SCFA

Analysis of short chain fatty acids (SCFA) from stool and blood samples

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

Other outcomes

1

Dietary intake

The intake of dietary fibre and nutrients calculated from food records during run-in and fibre periods.

Time frame
6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.
2

Physical activity

Level of physical activity and inactivity determined using an accelerometer during run-in and fibre periods.

Time frame
6 weeks. Differences between the fibre periods and fibre periods and run-in period will be compared.
3

Metabolomics from feces, blood and urine

Targeted/untargeted analysis of fecal, blood and urine metabolome

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

Sponsors and contacts

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