Trial Outcomes & Findings for Assessing the Effect of Lettuce on Intestinal Water Content Through Magnetic Resonance Imaging of the Small Bowel (NCT NCT02939716)

Results Overview

Area under the curve of postprandial change from fasting small bowel water, 0-3 hours, measured by MRI, in mL\*min

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

18 participants

Primary outcome timeframe

0-3 hours

Results posted on

2020-07-31

Participant Flow

15 included in final analysis as scanner failure caused loss of data for 3 subjects

Participant milestones

Participant milestones
Measure	Healthy Volunteers. Bread Then Lettuce Then Rhubarb Healthy volunteers free from GI disease. Randomised to order Bread then Lettuce then Rhubarb	Healthy Volunteers. Bread Then Rhubarb Then Lettuce Healthy volunteers free from GI disease. Randomised to order Bread then Rhubarb then Lettuce	Healthy Volunteers. Lettuce Then Rhubarb Then Bread Healthy volunteers free from GI disease. Randomised to order Lettuce then Rhubarb then Bread	Healthy Volunteers. Lettuce Then Bread Then Rhubarb Healthy volunteers free from GI disease. Randomised to order Lettuce then Bread then Rhubarb	Healthy Volunteers. Rhubarb Then Bread Then Lettuce Healthy volunteers free from GI disease. Randomised to order Rhubarb then Bread then Lettuce	Healthy Volunteers. Rhubarb Then Lettuce Then Bread Healthy volunteers free from GI disease. Randomised to order Rhubarb then Lettuce then Bread
Overall Study STARTED	3	3	3	3	3	3
Overall Study COMPLETED	3	3	3	2	2	2
Overall Study NOT COMPLETED	0	0	0	1	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Healthy Volunteers. Bread Then Lettuce Then Rhubarb Healthy volunteers free from GI disease. Randomised to order Bread then Lettuce then Rhubarb	Healthy Volunteers. Bread Then Rhubarb Then Lettuce Healthy volunteers free from GI disease. Randomised to order Bread then Rhubarb then Lettuce	Healthy Volunteers. Lettuce Then Rhubarb Then Bread Healthy volunteers free from GI disease. Randomised to order Lettuce then Rhubarb then Bread	Healthy Volunteers. Lettuce Then Bread Then Rhubarb Healthy volunteers free from GI disease. Randomised to order Lettuce then Bread then Rhubarb	Healthy Volunteers. Rhubarb Then Bread Then Lettuce Healthy volunteers free from GI disease. Randomised to order Rhubarb then Bread then Lettuce	Healthy Volunteers. Rhubarb Then Lettuce Then Bread Healthy volunteers free from GI disease. Randomised to order Rhubarb then Lettuce then Bread
Overall Study scanner failure	0	0	0	1	1	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy Volunteers n=15 Participants Healthy volunteer group who participated
Age, Categorical <=18 years	0 Participants n=15 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=15 Participants
Age, Categorical >=65 years	0 Participants n=15 Participants
Sex: Female, Male Female	9 Participants n=15 Participants
Sex: Female, Male Male	6 Participants n=15 Participants
Region of Enrollment United Kingdom	15 participants n=15 Participants

PRIMARY outcome

Timeframe: 0-3 hours

Population: 15 healthy volunteers free from GI disorders.

Area under the curve of postprandial change from fasting small bowel water, 0-3 hours, measured by MRI, in mL\*min

Outcome measures

Outcome measures
Measure	Healthy Volunteers. Bread Arm. n=15 Participants Bread Arm.	Healthy Volunteers. Lettuce Arm n=15 Participants Lettuce Arm	Healthy Volunteers. Rhubarb Arm n=15 Participants Rhubarb Arm
Small Bowel Water Content Measured by MRI	-5662 mL*min Standard Error 1209	3194 mL*min Standard Error 1574	10586 mL*min Standard Error 1629

SECONDARY outcome

Timeframe: 0-3 hours

Population: Healthy Volunteers

Area under the curve of postprandial change from fasting ascending colon water, 0-3 hours, measured by MRI, in mL\*min

Outcome measures

Outcome measures
Measure	Healthy Volunteers. Bread Arm. n=15 Participants Bread Arm.	Healthy Volunteers. Lettuce Arm n=15 Participants Lettuce Arm	Healthy Volunteers. Rhubarb Arm n=15 Participants Rhubarb Arm
Ascending Colon Water Content	78 mL*min Standard Error 43	409 mL*min Standard Error 231	291 mL*min Standard Error 89

SECONDARY outcome

Timeframe: 0-3 hours

Population: Healthy volunteers free from GI disorders

Area under the curve of postprandial change from fasting small bowel water, 0-3 hours, measured by MRI in milliseconds.min

Outcome measures

Outcome measures
Measure	Healthy Volunteers. Bread Arm. n=15 Participants Bread Arm.	Healthy Volunteers. Lettuce Arm n=15 Participants Lettuce Arm	Healthy Volunteers. Rhubarb Arm n=15 Participants Rhubarb Arm
Relaxation Time in Ascending Colon	15188 ms*min Standard Error 6717	18990 ms*min Standard Error 7884	35744 ms*min Standard Error 9013

SECONDARY outcome

Timeframe: 0-180 min

Population: Healthy volunteers

Area under the curve of postprandial change from fasting bloating score, 0-180 min, measured by a 100 point visual analogue scale (VAS), where 0 is no symptom and 100 is worst symptom. Measured every 30 mins.

Outcome measures

Outcome measures
Measure	Healthy Volunteers. Bread Arm. n=15 Participants Bread Arm.	Healthy Volunteers. Lettuce Arm n=15 Participants Lettuce Arm	Healthy Volunteers. Rhubarb Arm n=15 Participants Rhubarb Arm
Bloating VAS Score	4196 VAS Score*Min Standard Error 637	7071 VAS Score*Min Standard Error 905	5113 VAS Score*Min Standard Error 927

SECONDARY outcome

Timeframe: 0-180 mins

Population: Healthy volunteers free from GI disorders

Area under the curve of postprandial change from fasting satiety score, 0-180 min, measured by a 100 point visual analogue scale (VAS), where 0 is no symptom and 100 is worst symptom. Measured every 30 mins.