ISRCTN58960980已完成不适用

Pilot study of nutritional intervention randomised, parallel, double-blind, placebo-controlled trial to assess the effects of the administration of a non-alcoholic beer enriched in soluble fibre compared with a non-alcoholic beer without fibre on bowel function in healthy subjects

Technology Centre of Nutrition and Health (Centre Tecnològic de Nutrició I Salut [CTNS]) (Spain)0 个研究点目标入组 32 人开始时间: 2010年4月15日最近更新: 2015年1月13日

试验速览

暂无简介。

•1. Adults aged 18 to 65 years, either sex
•2. Subject that consider normal bowel habits range using criteria of 1 stool per day to 1 stool every 3 days
•3. Subject that after understand the protocol and the study process has provided written informed consent to participate in the study
•4. Subject consider healthy according to medical history, physical examination and laboratory tests available
•5. Subject after the study of colonic transit time in the simple abdominal X-ray (RX) note the presence of some radio-opaque marker
•6. In women of childbearing age must have a urine pregnancy test negative within 48 hours prior to each day of the radiographic study
•7. Absence of abdominal surgery except appendectomy or herniorrhaphy
•8. Failure to take medication or drugs that alter intestinal motility (natural products including laxatives, antidiarrhoeals and antispasmodics)

•1. Subject that required treatment with laxatives, fibre and/or bulking agents (not digestible) in the 2 weeks prior start the study
•2. Subject after the study of colonic transit time in the simple abdominal X-ray (RX) NOT observe the presence of 10 or less radio-opaque marker
•3. Subject during the week preceding the study received treatment for faecal impaction enema
•4. Subjects who suffer from constipation secondary to other diseases (Hirschsprung disease, hypothyroidism, mental retardation, psychiatric disorders, neurological disorders, major abdominal or extraabodominal surgery)
•5. Subjects with renal insufficiency, hypocalcaemia, hypercalcaemia, or any metabolic disorder at baseline (or is detected) during the study
•6. Subjects with secondary gastrointestinal and systemic disorders
•7. Subjects who have used drugs that may affect intestinal motility (natural products including laxatives, antidiarrhoeals and antispasmodics)
•8. Inability to understand the study, its process and the needs required by the subject
•9. The subject is participating in a clinical trial or received an investigational product within thirty days prior to selection/inclusion in the study
•10. To have coeliac disease
•11. Allergy to alcohol-free beer
•12. Being pregnant or lactating

发起方

Technology Centre of Nutrition and Health (Centre Tecnològic de Nutrició I Salut [CTNS]) (Spain)