Innovative Tools to Produce Legume-based Foods for Increased Consumer Acceptance
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- The intensity of stomach noise measured by a visual analogue scale
研究概览
简要总结
The aim of this study is to investigate the effects of enzymatic treatment to reduce GOS (galactooligosaccharides) in legume-based crackers in IBS (irritable bowel syndrome) persons. The crackers are pea-based: the control crackers contain high amounts of GOS, while the enzymatically treated crackers contain a minimal amount of GOS. The participants will eat each type of cracker for three days (daily dose of 12 crackers) and report their gut symptoms (e.g. flatulence, stomach pain, bloating) by using a mobile app. There is a washout period of four days between the different crackers. In addition, the participants will keep food records on the cracker eating days as well as collect five fecal samples during the study. The participants will also report their physical activity and the number of defecations on each day. The study is carried out in a double-blinded crossover setting.
详细描述
A human intervention study with volunteers suffering from either irritable bowel syndrome (IBS) or functional bloating (FB) will be carried out to investigate the effects of enzymatic treatment of pea-based product on gastrointestinal symptoms and gut microbiota composition as well as hydrogen production due to carbohydrate fermentation. Enzyme-treated product will be compared to a control product.
The aim of the study is to investigate, whether enzyme-treated cracker, compared to a control product, will reduce gastrointestinaI symptoms, or have an impact on fecal microbiome or carbohydrate fermentation measured by breath hydrogen concentration. The effects of eating enzyme-treated crackers on food intake, exercise and stool frequency will also be investigated.
The study is carried out in a randomized, double-blinded, placebo-controlled crossover design. The study includes two 1-week treatment periods with 1-week run-in period before the intervention. Participants (N=35 at the maximum) are adult males and females who meet Rome IV criteria for IBS or FB.
Exclusion criteria will be as follows:
- coeliac disease
- inflammatory bowel disease
- pregnancy or breastfeeding
- antibiotics within the last 3 months
- colonoscopy and preparations for it within 4 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
The study is double-masked - neither the researchers or the participants know which cracker they are eating.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IBS (Rome IV criteria) or functional bloating
- •over 18 years old
排除标准
- •IBD (inflammatory bowel disease)
- •coeliac disease
- •pregnancy or breastfeeding
- •antibiotics within the last 3 months
- •colonoscopy and preparations for it within 4 weeks
结局指标
主要结局
The intensity of stomach noise measured by a visual analogue scale
时间窗: 2 weeks
Study participants report the intensity of experienced stomach noise on a scale of zero (no noise at all) to 100 (very loud noise) using a mobile application. The data will be summarized in Excel form and the differences between the treatments will be analyzed statistically.
The intensity of an unpleasant feeling in the upper abdomen or the feeling of feeling full fast related to eating measured by a visual analogue scale
时间窗: 2 weeks
Study participants report the intensity of an unpleasant feeling in the upper abdomen or the feeling of feeling full fast related to eating on a scale of zero (no no described unpleasant feeling at all) to 100 (very intense unpleasant feeling) using a mobile application. The data will be summarized in Excel form and the differences between the treatments will be analyzed statistically.
The intensity of stomach pain measured by a visual analogue scale
时间窗: 2 weeks
Study participants report the intensity of experienced stomach pain on a scale of zero (no pain at all) to 100 (very intense pain) using a mobile application. The data will be summarized in Excel form and the differences between the treatments will be analyzed statistically.
The intensity of nausea measured by a visual analogue scale
时间窗: 2 weeks
Study participants report the intensity of experienced nausea on a scale of zero (no nausea at all) to 100 (very intense nausea) using a mobile application. The data will be summarized in Excel form and the differences between the treatments will be analyzed statistically.
The intensity of heartburn measured by a visual analogue scale
时间窗: 2 weeks
Study participants report the intensity of experienced heartburn on a scale of zero (no heartburn at all) to 100 (very intense heartburn) using a mobile application. The data will be summarized in Excel form and the differences between the treatments will be analyzed statistically.
The intensity of a sudden need to defecate measured by a visual analogue scale
时间窗: 2 weeks
Study participants report the intensity of a sudden need to defecate on a scale of zero (no need to defecate at all) to 100 (very intense need to defecate) using a mobile application. The data will be summarized in Excel form and the differences between the treatments will be analyzed statistically.
The intensity of flatulence measured by a visual analogue scale
时间窗: 2 weeks
Study participants report the intensity of experienced flatulence on a scale of zero (no flatulence at all) to 100 (very intense flatulence) using a mobile application. The data will be summarized in Excel form and the differences between the treatments will be analyzed statistically.
The intensity of stomach cramps measured by a visual analogue scale
时间窗: 2 weeks
Study participants report the intensity of experienced stomach cramps on a scale of zero (no cramps at all) to 100 (very intense cramps) using a mobile application. The data will be summarized in Excel form and the differences between the treatments will be analyzed statistically.
The composition of gut microbiota analyzed from fecal samples using 16S rRNA amplicon sequencing
时间窗: 2 weeks
The composition of gut microbiota is analyzed from fecal samples using 16S rRNA amplicon sequencing and qPCR (quantitative polymerase chain reaction). The differences between the treatments will be analyzed statistically.
The intensity of bloating measured by a visual analogue scale
时间窗: 2 weeks
Study participants report the intensity of experienced bloating on a scale of zero (no bloating) to 100 (very bloated) using a mobile application. The data will be summarized in Excel form and the differences between the treatments will be analyzed statistically.
次要结局
未报告次要终点
研究者
Anne-Maria Pajari
Associate Professor
University of Helsinki