N/A
N=16
Effect of Kiwifruit on Gastrointestinal Fluid Distribution and Transit in Healthy Volunteers
Constipation · Diet Modification
Bottom Line
View on ClinicalTrials.gov: NCT03303417 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Relaxation Time in Ascending Colon — 312; 256 seconds*minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MRI Scan (Diagnostic_test); Kiwifruit (Other); calorie-matched sugar drink (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Nottingham
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Relaxation Time in Ascending Colon |
312; 256 | — |
| SECONDARY Small Bowel Water Content Measured by MRI, in mL |
85530; 35023 | — |
| SECONDARY Colonic Volume |
283583; 243182 | — |
| SECONDARY Colonic Transit Time |
0.8; 1.0 | — |
| SECONDARY Bowel Habit |
1.46; 1.14 | — |
Summary
Constipation is a widespread and common problem in which a person finds it difficult and/or painful to open their bowels. The current treatment is the use of medications called laxatives. Kiwifruit is a widely available food that has been shown to possess some laxative properties. The cause of this is unknown. Non-invasive medical imaging techniques such as Magnetic Resonance Imaging now allow taking pictures of the gut and its contents. The Nottingham GI MRI research group specialises in these techniques and in this study use such images to assess the changes induced in the gut contents by kiwifruit to improve understanding of how it helps patients with constipation.
The volunteers will be asked to undergo 2 studies in which they take either kiwifruit or placebo (sugary drink) two times a day for 2 days and then spend a study day where will they will be fed some more kiwifruit/placebo and some normal food and image their gut at intervals. Participants will be asked to complete a stool diary to determine if they experience a laxative effect.
Eligibility Criteria
Inclusion Criteria
- Healthy volunteers scoring within the normal range for bowel symptoms as assessed using the GSRS, aged 18-65 years.
Exclusion Criteria
- Inability to discontinue medication likely to alter GI transit.
- Previous gastrointestinal surgery (excluding cholecystectomy and appendectomy).
- Known inflammatory bowel disease, coeliac disease.
- Known intolerance of kiwifruit.
- Inability to discontinue drugs likely to alter gut transit.
- Subjects considered by the investigator unlikely to comply with study protocol.
Data sourced from ClinicalTrials.gov (NCT03303417). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.