Trial Outcomes & Findings for Effect of Kiwifruit on Gastrointestinal Fluid Distribution and Transit in Healthy Volunteers (NCT NCT03303417)

NCT ID: NCT03303417

Last Updated: 2019-06-17

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 16 participants
• Primary outcome timeframe: 0 - 8 hours
• Results posted on: 2019-06-17

Participant Flow

16 healthy volunteers were recruited from the population of Nottingham and surroundings. 2 dropped out after a single visit due to unexpected work commitments so 14 volunteers completed the study

Participant milestones

Measure	Kiwifruit Then Control Participants asked to consume 2 kiwifruit twice a day for 3 days before undergoing MRI Scan MRI Scan: Participants will undergo hourly MRI scans on day 3 to assess bowel fluid content Kiwifruit: Kiwifruit. Washout period of 2 weeks Then Participants asked to consume a calorie-matched sugar drink twice a day for 3 days before undergoing MRI Scan MRI Scan: Participants will undergo hourly MRI scans on day 3 to assess bowel fluid content calorie-matched sugar drink: calorie-matched sugar drink	Control Then Kiwifruit Participants asked to consume a calorie-matched sugar drink twice a day for 3 days before undergoing MRI Scan MRI Scan: Participants will undergo hourly MRI scans on day 3 to assess bowel fluid content calorie-matched sugar drink: calorie-matched sugar drink Washout of 2 weeks Then Participants asked to consume 2 kiwifruit twice a day for 3 days before undergoing MRI Scan MRI Scan: Participants will undergo hourly MRI scans on day 3 to assess bowel fluid content Kiwifruit: Kiwifruit
Overall Study STARTED	8	8
Overall Study COMPLETED	7	7
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Kiwifruit Then Control Participants asked to consume 2 kiwifruit twice a day for 3 days before undergoing MRI Scan MRI Scan: Participants will undergo hourly MRI scans on day 3 to assess bowel fluid content Kiwifruit: Kiwifruit. Washout period of 2 weeks Then Participants asked to consume a calorie-matched sugar drink twice a day for 3 days before undergoing MRI Scan MRI Scan: Participants will undergo hourly MRI scans on day 3 to assess bowel fluid content calorie-matched sugar drink: calorie-matched sugar drink	Control Then Kiwifruit Participants asked to consume a calorie-matched sugar drink twice a day for 3 days before undergoing MRI Scan MRI Scan: Participants will undergo hourly MRI scans on day 3 to assess bowel fluid content calorie-matched sugar drink: calorie-matched sugar drink Washout of 2 weeks Then Participants asked to consume 2 kiwifruit twice a day for 3 days before undergoing MRI Scan MRI Scan: Participants will undergo hourly MRI scans on day 3 to assess bowel fluid content Kiwifruit: Kiwifruit
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	All Study Participants n=14 Participants All participants randomised to either "Kiwifruit then Control" or "Control then Kiwifruit" Interventions
Age, Continuous	26 years n=14 Participants
Sex: Female, Male Female	6 Participants n=14 Participants
Sex: Female, Male Male	8 Participants n=14 Participants
Region of Enrollment United Kingdom	14 Participants n=14 Participants
BMI	23 kg/m^2 n=14 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Kiwifruit n=14 Participants Participants asked to consume 2 kiwifruit twice a day for 3 days before undergoing MRI Scan MRI Scan: Participants will undergo hourly MRI scans on day 3 to assess bowel fluid content Kiwifruit: Kiwifruit	Control n=14 Participants Participants asked to consume a calorie-matched sugar drink twice a day for 3 days before undergoing MRI Scan MRI Scan: Participants will undergo hourly MRI scans on day 3 to assess bowel fluid content calorie-matched sugar drink: calorie-matched sugar drink
Relaxation Time in Ascending Colon	312 seconds*minutes Standard Deviation 92	256 seconds*minutes Standard Deviation 97

SECONDARY outcome

Timeframe: 0 - 8 hours

Population: 14 participants completed the study

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

Outcome measures

Measure	Kiwifruit n=14 Participants Participants asked to consume 2 kiwifruit twice a day for 3 days before undergoing MRI Scan MRI Scan: Participants will undergo hourly MRI scans on day 3 to assess bowel fluid content Kiwifruit: Kiwifruit	Control n=14 Participants Participants asked to consume a calorie-matched sugar drink twice a day for 3 days before undergoing MRI Scan MRI Scan: Participants will undergo hourly MRI scans on day 3 to assess bowel fluid content calorie-matched sugar drink: calorie-matched sugar drink
Small Bowel Water Content Measured by MRI, in mL	85530 ml*minutes Standard Deviation 34923	35023 ml*minutes Standard Deviation 15557

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Kiwifruit n=14 Participants Participants asked to consume 2 kiwifruit twice a day for 3 days before undergoing MRI Scan MRI Scan: Participants will undergo hourly MRI scans on day 3 to assess bowel fluid content Kiwifruit: Kiwifruit	Control n=14 Participants Participants asked to consume a calorie-matched sugar drink twice a day for 3 days before undergoing MRI Scan MRI Scan: Participants will undergo hourly MRI scans on day 3 to assess bowel fluid content calorie-matched sugar drink: calorie-matched sugar drink
Colonic Volume	283583 ml*minutes Standard Deviation 59402	243182 ml*minutes Standard Deviation 46682

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Kiwifruit n=14 Participants Participants asked to consume 2 kiwifruit twice a day for 3 days before undergoing MRI Scan MRI Scan: Participants will undergo hourly MRI scans on day 3 to assess bowel fluid content Kiwifruit: Kiwifruit	Control n=14 Participants Participants asked to consume a calorie-matched sugar drink twice a day for 3 days before undergoing MRI Scan MRI Scan: Participants will undergo hourly MRI scans on day 3 to assess bowel fluid content calorie-matched sugar drink: calorie-matched sugar drink
Colonic Transit Time	0.8 Score on a scale Interval 0.0 to 1.4	1.0 Score on a scale Interval 0.5 to 3.1

SECONDARY outcome

Timeframe: 7 days

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

Outcome measures

Measure	Kiwifruit n=14 Participants Participants asked to consume 2 kiwifruit twice a day for 3 days before undergoing MRI Scan MRI Scan: Participants will undergo hourly MRI scans on day 3 to assess bowel fluid content Kiwifruit: Kiwifruit	Control n=14 Participants Participants asked to consume a calorie-matched sugar drink twice a day for 3 days before undergoing MRI Scan MRI Scan: Participants will undergo hourly MRI scans on day 3 to assess bowel fluid content calorie-matched sugar drink: calorie-matched sugar drink
Bowel Habit	1.46 stools per day Standard Deviation 0.66	1.14 stools per day Standard Deviation 0.46

Adverse Events

Kiwifruit

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Robin Spiller

University of Nottingham

Phone: 0115 823 1090

Email: robin.spiller@nottingham.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place