Effects of a bitter substance and a menthol solution on digestion - BitterHC study
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 25
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 35 Years 至 60 Years（—）
- 性别
- All
入选标准
- •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
排除标准
- •- 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