A Two-center, Randomized, Double-blind, Placebo Controlled, Parallel Study to Evaluate the Effect of Polydextrose on Fecal Bulk and Bowel Function in Mildly Constipated Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Tate & Lyle
- 入组人数
- 51
- 主要终点
- Faecal bulk
研究概览
简要总结
Polydextrose (PDX) (8-30g/day) has been reported to increase faecal bulk and consistency, leading to easier stool passage in healthy subjects. Studies on its effect on defaecation frequency and colonic transit time have provided mixed results. The primary objective was to investigate the effect of PDX consumption by mildly constipated subjects on faecal bulk, measured as total faecal wet weight of 4-day collections. Secondary outcomes (faecal dry weight, defaecation frequency, stool consistency, ease of stool passage, total colonic transit time and gastrointestinal symptoms) were also explored. 51 subjects participated in a 4-week, two-center, randomized, double-blind, placebo-controlled, parallel study testing a control (CON) and a PDX treatment (18 g/d included in biscuits and drink mixtures)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Mildly constipated healthy adults (who defecate 3- 5 days per week assessed by a 7-day bowel diary)
- •Provision of signed and dated informed consent prior to any study procedures
- •Body mass index (BMI) ≥ 19 and ≤ 29 kg/m2 at the screening visit
- •Total score on fibre intake questionnaire max 17 points for women and 20 points for men (where each point represents approximately 1 g fibre intake)
- •Use of adequate contraception in females of childbearing potential
排除标准
- •Regular use of laxatives
- •Use of medication which alters study subjects' gastrointestinal function (e.g. including but not exclusive neuroleptic medication, medication for Parkinson disease, opioids)
- •History of digestive disease (e.g. celiac disease, Crohn's disease, ulcerative colitis, gastrointestinal malignancy, fistula of intestine, ischemic colitis, bile acid malabsorption, repeated diverticulitis)
- •Type I and II diabetes
- •Previous major gastrointestinal surgery (e.g. intestinal resection, total gastrectomy, subtotal gastrectomy) or surgical treatment of obesity (within 6 months before the screening visit)
- •Present cancer (except basal cell skin cancer or squamous cell skin cancer, carcinoma in situ)
- •Untreated thyroid disease
- •History of stroke or myocardial infarction within six months prior the screening visit
- •Subjects who were actively dieting for weight loss, or had eating disorders (anorexia, bulimia)
- •Lack of compliance to the study procedures
- •Females who were pregnant or breast-feeding or planning pregnancy
- •Known or suspected abuse of alcohol (more than 14 units of alcohol per week, one unit = 4 cl spirit, 12 cl wine or 33 cl medium strong beer / cider),
- •Allergy/hypersensitivity/intolerance to study products
- •Vegetarians or regularly consuming fibre supplements/fibre supplemented foods
- •Any clinically significant disease/condition which in the Investigator's opinion could interfere with the results of the study
研究组 & 干预措施
Polydextrose (PDX)
Subject consumed a daily dose of 18g polydextrose enriched drink mixtures and biscuits (12 g from the drink mixtures and 6 g from the biscuits) providing 16.2 g dietary fibre/d.
干预措施: Polydextrose (Dietary Supplement)
Control (CON)
Subjects consumed placebo products, where maltodextrin replaced PDX and differed only in the amount of fibre per gram (1.7 g).
干预措施: placebo-controlled (Dietary Supplement)
结局指标
主要结局
Faecal bulk
时间窗: 4-day collections
Measured as total faecal wet weight
次要结局
- Faecal dry weight(4-day collections during the intervention period)
- Total colonic transit time(At the end of the intervention period for three consecutive days)
- Defaecation frequency(7-day period during the run-in period and intervention period)
- Stool consistency(7-day period during the run-in period and intervention period)
- Gastrointestinal symptoms(Once at the end of the intervention period and during the previous one week (7 day-period).)
- Ease of stool passage(At the end of the intervention period)