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
| ISRCTN | ISRCTN58960980 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58960980 |
| Secondary identifying numbers | N/A |
- Submission date
- 07/03/2010
- Registration date
- 15/04/2010
- Last edited
- 15/04/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Dr Rosa Sola
Scientific
Scientific
Hospital Universitari Sant Joan
Facultat de Medicina i Ciències de la Salut
C/ Sant Llorenç, nº 21
Reus
43201
Spain
Study information
| Study design | Randomised parallel double-blind placebo controlled pilot trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | 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 |
| Study acronym | Beer soluble fibre 01 |
| Study hypothesis | The inclusion of a significant content of soluble fibre in non-alcoholic beer positively affects markers of intestinal motility and colonic transit time, contributing to the prevention of constipation. |
| Ethics approval(s) | Comité Ètic d'Investigació Clínica Hospital Universitari Sant Joan, REUS (Spain) approved on the 29th October 2009 (ref: 09-10-29/10 assN1) |
| Condition | Bowel function |
| Intervention | Participants will take, during the 3 days prior to the simple abdominal Rx, 20 radio-opaque markers by day at the same time that the Rx will take place. If more than 10 radio-opaque markers are present in plaque, the participant will be entered into the study and will be delivered the product allocated by randomisation. Non-alcoholic beer enriched or without soluble fibre (250 mL) should be taken half an hour before dinner during the 21 days. At the end of the intervention the simple abdominal Rx with radio-opaque markers was repeated, with the 3 days prior to observe the effects of non-alcoholic beer enriched in soluble fibre on intestinal transit. Participants must maintain their usual diet, monitored by a 3-day food record at the beginning and end of intervention, their physical activity that will be controlled by a physical activity questionnaire at the beginning, in the middle and the end of intervention and their fluid intake that will be recorded at the beginning, in the middle and the end of intervention. The control group consume non-alcoholic beer without soluble fibre. The total duration is 21 days for each arm (intervention group and control group). |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Soluble fibre |
| Primary outcome measure | Colonic transit time, measured at inclusion (day 1) and at the end of the study (day 21) |
| Secondary outcome measures | Measured at inclusion (day 1) and at the end of the study (day 21): 1. Anthropometric measures 2. Control of the deposition rate and Bristol Scale Stool form 3. Satiety degree 4. General biochemical profile (lipid profile and insulin resistance) |
| Overall study start date | 18/11/2009 |
| Overall study end date | 30/03/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 32 |
| Participant 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) |
| Participant 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 |
| Recruitment start date | 18/11/2009 |
| Recruitment end date | 30/03/2010 |
Locations
Countries of recruitment
- Spain
Study participating centre
Hospital Universitari Sant Joan
Reus
43201
Spain
43201
Spain
Sponsor information
Technology Centre of Nutrition and Health (Centre Tecnològic de Nutrició I Salut [CTNS]) (Spain)
Research organisation
Research organisation
c/o Francesc Puiggros
Camí de Valls, 81-87
Reus
43204
Spain
| Website | http://www.ctns.cat |
|---|---|
"ROR" |
https://ror.org/00mzj5z57 |
Funders
Funder type
Research organisation
Technology Centre of Nutrition and Health (Centre Tecnològic de Nutrició I Salut [CTNS]) (Spain)
No information available
HeSA (Spain)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
