The Impact of a Dried Vegetable on Bowel Function and Gut Microbiota in Subjects with Bowel Function Issues
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Bowel function (differences highest dose vs placebo) - feeling of incomplete bowel emptying
研究概览
简要总结
A randomized, placebo-controlled, parallel, double-blind trial with three intervention arms and a period of four intervention-weeks that assesses the intake of different dosages of a complex fiber product on bowel function via microbiota changes in subjects that are unsatisfied with their current bowel function.
详细描述
Background: Bowel function issues can have a substantial effect on quality of life. Additional fiber intake might modulate bowel function and gut microbiota, thereby increasing stool frequency and consistency. This could improve defecation ease, feeling of incomplete bowel emptying and bowel function satisfaction. We hypothesize that a dried vegetable, that is naturally high in fiber within plant cells could improve bowel function in subjects with bowel function issues.
Objective: The main objective of the study is to assess whether a dried multifiber vegetable improves bowel function assessed by stool frequency, consistency, defecation ease, feeling of incomplete bowel emptying and satisfaction. Secondary objectives are to assess whether these effects are dose-dependent and associated with the modulation of the gut microbiota and activity. Furthermore, the adaption of bowel function and adaptation of the gut microbiota and activity over time will be analyzed.
Study design: A parallel, randomized, double-blind, placebo-controlled trial of four weeks with one placebo control and three intervention arms that differ in intervention product dose.
Study population: Healthy human volunteers, 20 - 80y old, with bowel function issues reflected in low stool frequency/consistency, difficulty to defecate, and dissatisfaction with their current bowel function.
Intervention: A vegetable product consisting of dried chicory root cubes containing 85% dietary fiber is added to the daily diet. The intervention product is consumed twice daily for four weeks with a maximum dose of 15 g/day. The control (placebo) consists of easily digestible rice puff particles and is consumed in the same manner as the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Subjects not receiving the intervention product will consume a placebo (rice puff particles). Neither the investigator, nor the participants, nor the outcome assessor will know who received what. No Care Provider is included in this trial.
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •20 - 80 years old
- •Unsatisfied with bowel functions (self-reported), rated on a visual analogue scale (VAS, 0-10) as less than 6
- •Four or less bowel movements per week (low stool frequency) and/or
- •Hard, lumpy or solid stools (Bristol stool form 1-4) during 90% of bowel movements (hard to solid consistency)
- •Able to read and understand Dutch or English
排除标准
- •Having a history of medical or surgical events that may significantly affect the study outcome: e.g., IBS or IBD patients and subjects with medically diagnosed constipation (i.e., constipation related to anatomic, medication-related, or readily identifiable physiological causes.)
- •Less than one bowel movement per week during the screening
- •Medical drug use:
- •Antibiotic use within 3 months of the study screenings day
- •Chronic use of antacids and PPI's
- •Use of laxatives during the screening
- •Chronic use of blood glucose lowering medication
- •Consumption of supplements containing fibres (other than laxatives), pro-/ post-/ synbiotics 1 month before the screening
- •Not willing to provide faecal samples
- •Unable to comply with proper study procedures
- •For women of childbearing age: current or planned pregnancy, lactation
- •Known allergic reactions to plants from the Asteraceae (Compositae) family (e.g., lettuce, daisies, sunflowers, artichokes, sage, tarragon, chamomile, chicory etc.)
- •Reported unexplained weight loss or weight gain of greater than 5 kg in the month prior to pre-study screening
- •Reported slimming or medically prescribed diet
- •Reported macrobiotic lifestyle
- •Personnel the Division of Human Nutrition & Health or the Laboratory of Microbiology
- •Current participation in other medical scientific research
- •Not having a general practitioner
- •Not willing to be informed about accidental discoveries in relation to the subjects health
研究组 & 干预措施
Highest fiber dose
This arm receives the highest dose of the intervention product, which is 15g dried vegetable per day divided into two portions of each 7.5g, which are consumed during the course of the day in the food of choice.
干预措施: Dried chicory root particles (Dietary Supplement)
Medium fiber dose
This arm receives the highest dose of the intervention product, which is 10g dried vegetable per day divided into two portions of each 5.0g, which are consumed during the course of the day in the food of choice.
干预措施: Dried chicory root particles (Dietary Supplement)
Lowest fiber dose
This arm receives the highest dose of the intervention product, which is 5g dried vegetable per day divided into two portions of each 2.5g, which are consumed during the course of the day in the food of choice.
干预措施: Dried chicory root particles (Dietary Supplement)
Control
This arm is the control arm receiving as placebo rice puff particles each day, whose amount corresponds iso-calorically to the medium fiber dosage (~ 21 kcal/day).
干预措施: Placebo (Other)
结局指标
主要结局
Bowel function (differences highest dose vs placebo) - feeling of incomplete bowel emptying
时间窗: Change after the intervention of 4 weeks
Feeling of incomplete bowel emptying is rated on a five-point scale (from "0-not at all" to "4-extremely").
Bowel function (differences highest dose vs placebo) - stool consistency
时间窗: Change after the intervention of 4 weeks
Stool consistency is measured using the Bristol Stool Form Scale (7-point scale from 1=hard to 7=diarrhea).
Bowel function (differences highest dose vs placebo) - stool frequency
时间窗: Change after the intervention of 4 weeks
Stool frequency is measured by counting number of bowel movements per week.
Bowel function (differences highest dose vs placebo) - bowel function satisfaction
时间窗: Change after the intervention of 4 weeks
Bowel function satisfaction is rated on a five-point scale (from "0-not at all" to "4-extremely").
Bowel function (differences highest dose vs placebo) - ease of defecation
时间窗: Change after the intervention of 4 weeks
Ease of defecation is rated on a five-point scale (from "0-not at all" to "4-extremely").
次要结局
- Fecal gut microbiota (between dose differences)(Change after the intervention of 4 weeks)
- Fecal gut microbiota activity (between dose differences)(Change after the intervention of 4 weeks)
- Quality of Life (between dose differences)(Change after the intervention of 4 weeks)
- Constipation-related symptoms (between dose differences)(Change after the intervention of 4 weeks)
- Bowel function (between dose differences) - bowel function satisfaction(Change after the intervention of 4 weeks)
- Bowel function (between dose differences) - ease of defecation(Change after the intervention of 4 weeks)
- Bowel function (between dose differences) - feeling of incomplete bowel emptying(Change after the intervention of 4 weeks)
- Bowel function (between dose differences) - stool consistency(Change after the intervention of 4 weeks)
- Bowel function (between dose differences) - stool frequency(Change after the intervention of 4 weeks)
研究者
Edith Feskens
Prof. dr. Edith Feskens
Wageningen University