The effects of a non-alcoholic beer enriched in soluble fibre compared with a non-alcoholic beer without fibre on bowel function in healthy subjects

Completed

• Conditions: Bowel function; Digestive System; Other diseases of intestine

• Registration Number: ISRCTN58960980
• Lead Sponsor: Technology Centre of Nutrition and Health (Centre Tecnològic de Nutrició I Salut [CTNS]) (Spain)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-15
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

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)

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Colonic transit time, measured at inclusion (day 1) and at the end of the study (day 21)

Secondary Outcome Measures

Name	Time	Method
Measured at inclusion (day 1) and at the end of the study (day 21):<br>1. Anthropometric measures<br>2. Control of the deposition rate and Bristol Scale Stool form<br>3. Satiety degree<br>4. General biochemical profile (lipid profile and insulin resistance)