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 volunteersQualifiers
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
Crossover
Treatments tested in this trial
cellulose
Dietary supplementMicrocrystalline 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 supplementOat 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 supplementRye 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
Trial outcomes
Primary outcomes
Intensity of gastrointestinal symptoms, total score
The composite score of the intensity of individual gastrointestinal symptoms reported on a VAS scale by the participants.
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.
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.
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.
Secondary outcomes
Composition and function of gut microbiome
Microbiota-related analyses of the collected stool samples are carried out using DNA-based methods
Number of bowel movements
Number of bowel movements reported by participants on daily basis using a mobile app.
Breath gases
Hydrogen and methane measured from exhaled breath samples during run-in and fibre periods.
Fecal and blood SCFA
Analysis of short chain fatty acids (SCFA) from stool and blood samples
Other outcomes
Dietary intake
The intake of dietary fibre and nutrients calculated from food records during run-in and fibre periods.
Physical activity
Level of physical activity and inactivity determined using an accelerometer during run-in and fibre periods.
Metabolomics from feces, blood and urine
Targeted/untargeted analysis of fecal, blood and urine metabolome
Sponsors and contacts
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