Gastrointestinal health Digestive System
Conditions
Interventions
Participants will be randomly assigned to receive a small or a large portion of prunes or control (water) to be consumed every day in addition to the normal diet, for 4 weeks. The small portion of pru
Sponsors
King's College London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult men and women between the ages of 18 to 65 years 2. Adults with stool frequency of 3-6 times per week 3. Adults able to give informed consent
Exclusion criteria
Exclusion criteria: 1. Regular consumption of dried fruit (based on specific screening questions) 2. Consumption of more than one portion of whole grain cereals per day (>1 x 80g) and more than three portions of fruit and vegetables per day (>3 x 80g) or more than five portions of fruit and vegetables per day (>5 x 80g) 3. Dislike of prunes 4. Consumption of any pre or probiotic (in food products or as supplements) in the last 4 weeks prior to, or during the study 5. Adults taking medications known to effect gut motility, for example prokinetic agents (such as metoclopramide, domperidone, erythromycin, azithromycin), anti-emetics agents, narcotic analgesic agents (such as methadone, fentanyl), anticholinergic agents for irritable bowel syndrome [BS], medications for constipation (including enemas, cathartics, polyethylene glycol solutions, lactulose), 5HT3 antagonists, anti-diarrheal agents (such as loperamide), opiate agents used to treat diarrhoea, non-steroidal anti-inflammatory drugs [NSAIDs] (more than once daily). 6. Subjects who have taken a course of antibiotics in the last 4 weeks prior to, or during the study 7. Subjects with any gastro-intestinal disease including IBD and coeliac disease, history of diverticulitis 8. Subjects with co-morbid illnesses such as cardiovascular, endocrine, renal or other chronic disease likely to affect motility 9. Previous GI surgery, except cholecystectomy and appendectomy 10. Patients with neurological diseases such as multiple sclerosis, strokes, spinal cord injuries, and those who have problems with cognizance, i.e. a mini-mental score of <15 and/or are legally blind will be excluded 11. Patients with Hirschsprung's disease, or active local anorectal problems such as anal fissures, bleeding haemorrhoids, etc 12. Subjects with eating disorders 13. Use (more than six times in last 3 months) of laxatives, fibre supplements etc 14. Patients defined as having constipation or IBS based upon Rome III criteria for both 15. Females of childbearing age who are not practicing birth control and/or who are pregnant or lactating. (A urine pregnancy test will be performed on female participants prior to X-ray fluoroscopy)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Difference in stool weight and frequency of bowel movement between the three study arms at the end of the intervention, as determined by a 7 day total stool collection at baseline and at the end of the intervention 2. Stool and symptom diary completed at baseline, two weeks, end of intervention and four week follow-up, respectively | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Difference in gastrointestinal transit time between the three groups at the end of the intervention, as determined by radio-opaque markers and abdominal X-ray fluoroscopy taken at baseline and end of intervention. 2. Difference in stool consistency and gastrointestinal symptoms between the three groups at the end of the intervention as determined by a 7 day stool and symptom diary completed at baseline, two weeks, end of intervention and four week follow-up. Measurements will include abdominal pain and discomfort, bloating or distension, increased flatulence, belching or burping, stomach or abdominal gurgling, urgency, incomplete evacuation, nausea, heartburn, acid regurgitation, tiredness and lethargy and number of complete spontaneous bowel movements (CSBM). Participants will classify all bowel movements throughout the study according to the Bristol Stool Chart. 3. Difference in stool water and pH between the three groups at the end of the intervention as determined by analysis of stool samples collected at baseline and at the end of the intervention. 4. Difference in stool microbiota and volatile compounds (e.g. short chain fatty acids) between the three groups at the end of the intervention, determined by qPCR and GLC analysis of stool samples collected at baseline and at the end of the intervention. 5. Difference in plasma levels of phenolic compounds between the three groups at the end of the intervention, determined by analysis of blood samples taken at baseline and at the end of the intervention. 6. Difference in appetite between the three groups at the end of the intervention as determined by questionnaire completed at baseline, end of intervention and four week follow-up. | — |
Countries
United Kingdom
Outcome results
None listed