Assessing the Effect of Lettuce on Intestinal Water Content Through Magnetic Resonance Imaging of the Small Bowel

NCT02939716 | Completed Results

• 1 other identifier: C12072016 MRI
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief Summary

When patients have bowel surgery they are sometimes left with a stoma, where the small bowel exits onto the wall of the abdomen, not into the colon. Certain foods have been shown to increase the amount of water lost through a stoma. This can lead to dehydration. Such patients are encouraged to avoid such foods but knowing which ones to avoid relies partly on trial and error. In a survey 1 in 3 patients said that rhubarb increased stoma output. Rhubarb is known to contain chemicals that can stimulate the bowel. 1 in 6 patients also reported the same effect with lettuce which has not previously been shown to have such an effect. Latex found in lettuce leaves may stimulate the bowel to produce more fluid, explaining this effect. In Nottingham the investigators have developed techniques that use Magnetic Resonance Imaging (MRI) to measure water in the small bowel. They want to use these techniques to explore whether eating lettuce increase small bowel water content. They will compare lettuce to rhubarb and to bread, which they know reduces small bowel water. They will see if they can detect any relationship between water in the bowel and feelings of bloating.

Conditions

Asymptomatic Conditions

Keywords

small bowel; bloating; flow

Outcome Measures

Primary Outcomes (1)

• Small Bowel Water Content Measured by MRI

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

  0-3 hours

Secondary Outcomes (4)

• Ascending Colon Water Content

  0-3 hours

• Relaxation Time in Ascending Colon

  0-3 hours

• Bloating VAS Score

  0-180 min

• Satiety VAS Score

  0-180 mins

Study Arms (3)

Rhubarb

ACTIVE COMPARATOR

300g frozen rhubarb, microwaved; served with 65g lactose free cream and saccharine sweetener

Other: Rhubarb

Bread

ACTIVE COMPARATOR

2 slices of white bread, 40g each; served with 10g butter

Other: Bread

Lettuce

EXPERIMENTAL

300g lettuce; served with 30g mayonnaise

Other: Lettuce

Interventions

Rhubarb OTHER

300gm rhubarb

Rhubarb

Bread OTHER

2 slices bread

Bread

Lettuce OTHER

300g lettuce

Lettuce

Eligibility Criteria

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

You may qualify if:

• Aged 18 or older
• Able to give informed consent

You may not qualify if:

• Pregnancy declared by candidate
• History declared by the candidate of pre-existing gastrointestinal disorder that may affect bowel function
• A positive diagnosis of irritable bowel syndrome based on the Rome III criteria questionnaire
• Reported history of previous resection of the oesophagus, stomach or intestine (excluding appendix)
• Intestinal stoma
• Any medical condition making participation potentially compromising participation in the study e.g. diabetes mellitus, respiratory disease limiting ability to lie in the scanner, known allergy to one of the food products
• Contraindications for MRI scanning i.e. metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury
• Will not agree to dietary restrictions required in 24 hours before each study day
• Inability to lie flat or exceed scanner limits of weight \<120kg
• Poor understanding of English language
• Participation in night shift work the week prior to the study day. Night work is defined as working between midnight and 6.00 in the morning
• Participation in any medical trials for the past 3 months
• Anyone who in the opinion of the investigator is unlikely to be able to comply with the protocol e.g. cognitive dysfunction, chaotic lifestyle related to substance abuse

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (2)

Sir Peter Mansfield Imaging Centre

Nottingham, NG7 2RD, United Kingdom

Location

Nottingham Digestive Diseases Centre

Nottingham, NG7 2UH, United Kingdom

Location

MeSH Terms

Conditions

Asymptomatic Diseases

Interventions

rhubarb peony decoction; Bread

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Robin Spiller
• Organization: University of Nottingham

robin.spiller@nottingham.ac.uk

01158231090

Study Officials

• Robin Spiller

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Gastroenterology

Study Record Dates

• First Submitted: October 13, 2016
• First Posted: October 20, 2016
• Study Start: October 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: July 31, 2020
• Results First Posted: July 31, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)