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

NCT03303417 | Completed Results

• 1 other identifier: A200317
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Constipation; Diet Modification

Keywords

Kiwifruit

Outcome Measures

Primary Outcomes (1)

• Relaxation Time in Ascending Colon

  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

  0 - 8 hours

Secondary Outcomes (4)

• Small Bowel Water Content Measured by MRI, in mL

  0 - 8 hours

• Colonic Volume

  0 - 8 hours

• Colonic Transit Time

  24hr

• Bowel Habit

  7 days

Study Arms (2)

Kiwifruit

EXPERIMENTAL

Participants asked to consume 2 kiwifruit twice a day for 3 days before undergoing MRI Scan

Diagnostic Test: MRI Scan; Other: Kiwifruit

Control

PLACEBO COMPARATOR

Participants asked to consume a calorie-matched sugar drink twice a day for 3 days before undergoing MRI Scan

Diagnostic Test: MRI Scan; Other: calorie-matched sugar drink

Interventions

MRI Scan DIAGNOSTIC_TEST

Participants will undergo hourly MRI scans on day 3 to assess bowel fluid content

Control; Kiwifruit

Kiwifruit OTHER

Kiwifruit

Kiwifruit

calorie-matched sugar drink OTHER

calorie-matched sugar drink

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers scoring within the normal range for bowel symptoms as assessed using the GSRS, aged 18-65 years.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nottingham: lead
• Zespri International Limited: collaborator

Study Sites (1)

University of Nottingham

Nottingham, Nottinghamshire, United Kingdom

Location

MeSH Terms

Conditions

Constipation

Interventions

Magnetic Resonance Imaging; alcohol acyltransferase, Actinidia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Limitations and Caveats

This mechanistic study was limited by small sample size which was exacerbated by some participants' withdrawal from the study. Did not control any other aspects of diet

Results Point of Contact

• Title: Robin Spiller
• Organization: University of Nottingham

robin.spiller@nottingham.ac.uk

0115 823 1090

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: MRI analysis will be performed blind to the intervention
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 2, 2017
• First Posted: October 6, 2017
• Study Start: June 27, 2017
• Primary Completion: November 1, 2017
• Study Completion: June 1, 2018
• Last Updated: June 17, 2019
• Results First Posted: June 17, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)