NCT03303417: KIWI

Effect of Kiwifruit on Gastrointestinal Fluid Distribution and Transit in Healthy Volunteers

Completed NA Results posted Last updated 17 June 2019

What this trial tests

NA trial testing MRI Scan in Constipation in 16 participants. Completed in 1 June 2018.

Timeline

27 June 2017

Primary endpoint
1 November 2017

1 June 2018

Quick facts

Lead sponsor	University of Nottingham
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	basic science
Enrollment	16
Start date	27 June 2017
Primary completion	1 November 2017
Estimated completion	1 June 2018
Sites	1 location across United Kingdom

Drugs / interventions tested

• MRI Scan
• Kiwifruit
• calorie-matched sugar drink

Conditions studied

• Constipation — all drugs for Constipation →
• Diet Modification — all drugs for Diet Modification →

Sponsor

University of Nottingham

Who can join

Adults 18 to 65, any sex, with Constipation or Diet Modification. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Relaxation Time in Ascending Colon Primary · 0 - 8 hours

Area under curve of Ascending colon T1 measured on MRI , in milliseconds. Measurements at 0, 1, 2, 3, 4, 5, 6, 7, and 8 hours post-intervention

Group	Value	95% CI
Kiwifruit	312	± 92
Control	256	± 97

Small Bowel Water Content Measured by MRI, in mL Secondary · 0 - 8 hours

Area under the curve of change of small bowel water, 0-8 hours, measured by MRI, in mL Measurements at 0, 1, 2, 3, 4, 5, 6, 7, and 8 hours post-intervention

Group	Value	95% CI
Kiwifruit	85530	± 34923
Control	35023	± 15557

Colonic Volume Secondary · 0 - 8 hours

Ascending (AC), transverse (TC) and descending (DC) colonic volumes, measured by MRI, in mL Data given: AUC for total colon Measurements at 0, 1, 2, 3, 4, 5, 6, 7, and 8 hours post-intervention

Group	Value	95% CI
Kiwifruit	283583	± 59402
Control	243182	± 46682

Colonic Transit Time Secondary · 24hr

Transit of markers through gut as assessed by the weighted average position score (total score 0-7, calculated from a score of 0-7 of each of the 5 marker pills) at 24 h on MRI A lower score indicates faster transit.

Group	Value	95% CI
Kiwifruit	0.8	0 – 1.4
Control	1.0	0.5 – 3.1

Bowel Habit Secondary · 7 days

Assessment, via Diary, of bowel frequency Data given: stool frequency

Group	Value	95% CI
Kiwifruit	1.46	± 0.66
Control	1.14	± 0.46

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Mechanisms underlying effects of kiwifruit on intestinal function shown by MRI in healthy volunteers.
   Wilkinson-Smith V, Dellschaft N, Ansell J, Hoad C, et al · · 2019 · cited 39× · PMID 30706488 · DOI 10.1111/apt.15127