Randomised Controlled Trial of Efficacy of Resistant Maltodextrins on Reducing Colonic Transit Time
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Changes in Colonic Transit Time (CTT)
研究概览
简要总结
The purpose of this study is to assess the efficacy of resistant maltodextrins, compared to placebo, in reducing the colonic transit time in healthy subjects.
详细描述
In the last fifty years we have drastically changed our eating habits, in particular our fibre intake. Our hunter-gatherer ancestors ate more than 100 species of fruit and vegetables, which contributed between 20 and 30 g of dietary fibre per day. Currently, a typical citizen of our country reaches 10% of that amount.
Therefore, fibre deficiency alters digestion and metabolism, increasing nutrient absorption (obesity, increased insulin resistance, hyperlipidaemias), produces altered colonic metabolism (inflammatory bowel disease), and slows faecal transit (increasing the lumen pressure with diverticulosis, appendicitis, haemorrhoids and colon cancer. In addition, the prebiotic effect is important.
Several studies have demonstrated the effectiveness of digestion-resistant maltodextrin in the treatment of chronic idiopathic constipation. Investigators carried out a single blind study among young people with constipation who were administered 9.2 grams of resistant maltodextrins per day or placebo, and found significant changes in defecation frequency and in faecal volume.
Kimura et al. carried out a clinical trial in women with constipation and a defecation frequency of less than 3 times per week and administered 5 grams of resistant maltodextrins per day, demonstrating its effectiveness in significantly increasing the number of defecations per week, the number of days per week without defecation and the faecal volume. Additionally, an improvement was found aspects such as colour, stool odour and psychological feeling after defecation.
Finally, an interesting feature of Resistant maltodextrins is that it normalises the colonic transit time without causing diarrhoea, whilst increasing the stool volume, moisture and frequency of defecation.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects of both sexes (men and women) between 18 and 30 years old of Caucasian race selected from the general population
- •Subjects capable of understanding the clinical study, willing to provide written informed consent and to fulfil the procedures and requirements of the study.
排除标准
- •Diagnosis of a BMI ≥ 30 Kg/m
- •Individuals with a daily defecation habit.
- •Subjects with a history of any digestive disease or who have undergone gastrointestinal surgery (excluding appendicectomy or herniorrhaphy), abdominal surgery in the last two years or any recent major extra-abdominal surgery.
- •Subjects with diabetes, hypothyroidism or hyperthyroidism.
- •Subjects with a history of systemic disease that might effect gut motility.
- •Subjects on dietary treatment and/or drugs that effect body weight or appetite.
- •Individuals that have had any change in dietary habit in the last 2 months.
- •Subjects with a history of drug or alcohol abuse, or other substances or factors that might limit their ability to cooperate during the study.
- •Subjects with bowel habits affected by stress.
- •Subjects taking medication or drugs that alter gut motility.
- •Pregnant women.
- •Subjects that have stopped smoking in the last 6 months or who intend to give up smoking during the study.
- •Subjects with allergies or eating disorders.
- •Subjects that consume an excessive amount of alcohol (>3 glasses of wine or beer per day)
- •Individuals that engage in physical exercise two or more times per week.
- •Subjects whose condition makes them ineligible to take part in the study, according to the investigator.
研究组 & 干预措施
Maltodextrins
15 grams of maltodextrins per day dissolved in water during 21 days
干预措施: placebo (Other)
Resistant maltodextrins
15 grams of resistant maltodextrins per day, dissolved in water during 21 days
干预措施: Resistant maltodextrins (Dietary Supplement)
结局指标
主要结局
Changes in Colonic Transit Time (CTT)
时间窗: 28 days from the start of the study
to determine CTT volunteers should ingest a capsule of radiopaque markers each day for five consecutive days. 24 hours after the final intake of markers an abdominal X-ray should be performed.
次要结局
- Segmental colonic transit time (SCTT)(28 days from the start of the study)
- Assessment of dietary fibre intake(from day 2 to day 6 and from day 23 to day 27)
- Efficacy Blood analysis(28 days)
- Stool Consistency(28 days)
- Stool volume by just their eye observation(28 days)
- Defecation frequency (DF)(28 days)
- Clinical Variables of Intestinal Function(28 days)
- Safety Blood analysis(29 days)