NCT04086134Unknown不适用
The FruGut Study: Physiological, Microbiological and Metabolomic Effects of Fruit Products
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Change in faecal weight between baseline and week 4
研究概览
简要总结
This study is a randomised, parallel group, controlled trial, comparing the effects of fruit products as to their physiological, microbiologic and metabolomic effects on the gut, as well as their effects on the dietary intake and quality in healthy people with constipation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 18-65 years.
- •Individuals meeting the Rome IV criteria for functional constipation, in addition to having <7 bowel movements per week and hard or lumpy stools present in ⩾25% of their defecations (defined as Type 1 & 2 of the Bristol Stool Form Scale).
- •Individuals who are willing to consume fruit products for 4 weeks.
- •Individuals who consume <30g of fibre per day
- •Individuals with a BMI of 18.5-29.99 kg/m
- •Individuals able to give informed consent.
排除标准
- •Females who report to be pregnant or lactating.
- •Regular consumers of the fruit products used in the intervention arm 1 (3 or more portions per week).
- •Allergy, intolerance or dislike of the fruit products used in this intervention.
- •Sulphite allergy or sensitivity.
- •Ongoing alcohol, drug or medication abuse.
- •Major medical condition (diabetes, psychiatric or current eating disorders), gastrointestinal disease (e.g. inflammatory bowel disease, coeliac disease) or history of previous GI surgery, except cholecystectomy, appendicectomy and haemorrhoidectomy.
- •Medications which affect their gut physiology, function and symptoms in the last 4 weeks, and individuals who are not willing or cannot discontinue them.
- •Frequent use of rescue laxatives.
结局指标
主要结局
Change in faecal weight between baseline and week 4
时间窗: week 4
Change in 7-day faecal weight
次要结局
- Stool output(week 0 and 4)
- Compliance(week 0 and 4)
- Faecal microbiome(week 0 and 4)
- Individual gastrointestinal symptoms(week 0 and 4)
- Faecal microbiome diversity(week 0 and 4)
- Faecal metabolomic profile(week 0 and 4)
- Gastrointestinal symptom severity questionnaire - CCCS(week 0 and 4)
- Urine metabolomic profile(week 0 and 4)
- Faecal water content(week 0 and 4)
- Dietary intake(week 0 and 4)
- Whole and regional gut transit time/pH(week 0 and 4)
- Acceptability of interventions(week 0 and 4)
- Faecal short-chain fatty acids(week 0 and 4)
- Faecal pH(week 0 and 4)
- Gastrointestinal symptoms - PAC-SYM(week 0 and 4)
- Constipation-related quality of life(week 0 and 4)
研究者
研究点 (2)
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