Effects of a bitter substance and a menthol solution on digestio
- Conditions
- healthy subjects with occasional digestive complaints (assessment via score system (Guyonnet et al.))
- Registration Number
- DRKS00030323
- Lead Sponsor
- BitterPower GmbH
- Brief Summary
A bitter compound-containing dietary supplement was shown in a randomized, placebo-controlled crossover study to significantly reduce the frequency of flatulence in healthy adults. The effect on other digestion-related endpoints was highly variable among individuals. The mean frequency of flatulence over 48 hours was significantly lower in the intervention group compared to the control group (26.8 vs. 31.6; p=0.027). Secondary endpoints did not differ between groups. However, for each endpoint, responders (52-60% of participants) were identified, in whom the intervention led to significantly lower values. Predictive factors for this response were not investigated in the study. It is assumed that, in addition to biological factors (e.g., TAS2R expression), individual taste preferences and dietary habits may have influenced the results.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 25
age from 35 - 60 years
- regular bowel movements
- occasional, non-specific digestive complaints (without corresponding medical diagnosis), recorded by means of a screening questionnaire (Guyonnet et al., 2009); for study inclusion, an OSS between 8 and 16 or at least one complaint with OSS 4 is required
- sufficient knowledge of German to understand the study documents and procedure
- BMI < 18 kg/m² or > 29.9 kg/m²
- acute illness with influence on gastrointestinal functions
- medical diagnosis regarding digestive complaints
- regular intake of drugs or dietary supplements with gastrointestinal effects/adverse effects
- intake of drugs with potential interactions with the bitter substance solution or the menthol solution
- use of antibiotics in the last four weeks prior to study entry
- consumption of illegal substances
- pregnancy or lactation
- alcohol abuse (acute or in the medical history)
- contraindications (e.g. allergies, intolerances) to the meals used in the study (standard meal and high flatulence meal), the bitter solution or the menthol solution
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method flatulence
- Secondary Outcome Measures
Name Time Method fullness, cravings, overall digestion