A randomised controlled trial investigating the dose dependent effect of prunes on gastrointestinal health in adults with infrequent bowel movements

King's College London (UK)0 sites120 target enrollmentFebruary 10, 2012

ConditionsGastrointestinal health Digestive System

Overview

Phase: 未知
Intervention: Not specified
Conditions: Gastrointestinal health
Sponsor: King's College London (UK)
Enrollment: 120
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

2018 results in https://www.ncbi.nlm.nih.gov/pubmed/29398337

Registry

who.int

Start Date

February 10, 2012

End Date

October 1, 2012

Last Updated

8 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

King's College London (UK)

Eligibility 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

•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