Effect of Physical Form of Apples on Gastrointestinal Function and Satiety: a MRI Study

October 10, 2018 updated by: University of Nottingham

Different physical form of apples had a significant effect on satiety and blood sugar levels which was shown in a 1977 study by Haber and his team (Haber et al.1977).It was suggested that , this effect was due to processing of the apples which modified the bioavailability of carbohydrate and fiber content.However this was not enough to explain the mechanistic effect of the apples. Within the last decade, the role of magenetic resonance imaging has been very promising in understanding gastrointestinal function and physiology. Recent MRI studies have measured changes in gastrointestinal volumes due to the effect of fermentable carbohydrates.

Apple contains fermentable carbohydrates or FODMAPs. They are known to be poorly absorbed in the small and exert an osmotic effect by increasing markedly small bowel water content in the intestinal lumen as demonstrated in imaging studies.(Murray et al 2014 and Placidi et al 2012). A reduction of FODMAPs in the diet of IBS sufferers has been found to alleviate functional gut symptoms demonstrated in several randomised controlled trials.

In order to fully understand the 1977 Haber study, the investigators would like to repeat the study using modern MRI methods in healthy volunteers and measure the volume changes in the stomach, small bowel and colon. In addition appetite and symptoms would also be investigated after ingesting each test meal.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

18 healthy volunteers will participate in this 3-way crossover study. They will attend one morning for each study, with the studies separated by approximately 1 week. We will measure breath hydrogen before the test meal, and after that approximately every hour for the next 5 h. We will also scan the subjects at baseline, immediately after the test meal and then approximately every hour for 5 hours postprandially. Subjects will be scanned on a research dedicated 1.5T MRI scanner. At baseline and every time the subjects come out of the MRI scanner we will ask them to rate their feelings of fullness, hunger and appetite as well their gastrointestinal symptoms on 100mm VAS scales. The subjects will be fed three types of Pink Lady apples test meals: whole apple, apple puree and apple juice. The apples will be sourced from supermarkets. The apple juice and apple puree will be prepared for this study by Campden BRI, a world famous food science research institute in Chipping Campden, UK. Each test meal will approximately provide 46g of available carbohydrate; 180kcal

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Nottingham, United Kingdom, NG7 2UH
        • University of Nottingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 18 or older
  • Able to give informed consent

Exclusion Criteria:

  • Aversion to the test product
  • Unable to eat whole fruit due to poor dentition or other reasons
  • Pregnancy and lactation 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 potentially compromising participation in the study e.g. diabetes mellitus, respiratory disease limiting ability to lie in the scanner
  • Contraindications for MRI scanning i.e. metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury
  • Unable to limit alcohol intake to ≤ 35 units/ week and ≤ 8 units per day during trial and to avoid alcohol the day before each study day
  • Unable to stop drugs known to alter GI motility including mebeverine, opiates, monoamine oxidase inhibitors, phenothiazines, benzodiazepines, calcium channel antagonists for the duration of the study (Selective serotonin reuptake inhibitors and low dose tricyclic antidepressants will be recorded but will not be an exclusion criteria)
  • Antibiotic or prescribed probiotic treatment in the past 8 weeks
  • 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 AM
  • Participation in any medical trials for the past 3 months
  • Alteration in habitual diet in the last 6 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Whole Apple

Participants will be given 350g of whole apple and 150 mls water to be consumed in 20 minutes.

Serial MRI of gastrointestinal tract is done every 45 minutes from baseline until 315 minutes.
Other: Whole apples
350 of whole apples containing 49g of available carbohydrate with 173ml water
EXPERIMENTAL: Apple Puree

Participants will be given 384g of apple puree and 150 mls water to be consumed in 20 minutes.

Serial MRI of gastrointestinal tract is done every 45 minutes from baseline until 315 minutes.
Other: Apple puree
384g of apple puree containing 44g of available carbohydrates with 224 ml water
EXPERIMENTAL: Apple Juice

Participants will be given 338g of apple juice and 150 mls water to be consumed in 20 minutes.

Serial MRI of gastrointestinal tract is done every 45 minutes from baseline until 315 minutes
Other: Apple Juice
338g apple juice containing 46g of available carbohydrate with 260 ml water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean difference of small bowel water content (SBWC) in ml as measured by MRI from baseline to 315 minutes following ingestion of whole apple, apple puree and apple juice.
Time Frame: every 45 minutes from 0 minutes until 315 minutes
Small bowel water content will be measured in mililitres (ml) using in house software for every 45 minutes. Difference in means will be compared using repeated measure ANOVA.
every 45 minutes from 0 minutes until 315 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean difference of gastric volume measured by MRI from baseline to 315 minutes minutes following ingestion of whole apple, apple puree and apple juice.
Time Frame: every 45 minutes from 0 minutes until 315 minutes
Gastric volume in milliliters will be measured using MRI software every 45 minutes.Difference in means will be compared using repeated measure ANOVA.
every 45 minutes from 0 minutes until 315 minutes
Mean breath hydrogen measured from baseline to 315 minutes
Time Frame: every 45 minutes from 0 minutes until 315 minutes
Breath hydrogen is measured in parts per million (ppm) using a breath hydrogen meter
every 45 minutes from 0 minutes until 315 minutes

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in symptom severity
Time Frame: every 45 minutes from 0 minutes until 315 minutes for every intervention (whole apple, apple puree and apple juice)
Symptom severity measured using a visual analogue scale with a rating from 0 to 100 measured in millimeters (mm)
every 45 minutes from 0 minutes until 315 minutes for every intervention (whole apple, apple puree and apple juice)
Difference in appetite
Time Frame: every 45 minutes from 0 minutes until 315 minutes for every intervention (whole apple, apple puree and apple juice)
Appetite ratings measured using a visual analogue scale with a rating from 0 to 100 to rate fullness, satiety, hunger and desire to eat.
every 45 minutes from 0 minutes until 315 minutes for every intervention (whole apple, apple puree and apple juice)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nottingham

Collaborators

King's College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2016

Primary Completion (ACTUAL)

August 1, 2016

Study Completion (ACTUAL)

August 1, 2016

Study Registration Dates

First Submitted

October 10, 2018

First Submitted That Met QC Criteria

October 10, 2018

First Posted (ACTUAL)

October 22, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 22, 2018

Last Update Submitted That Met QC Criteria

October 10, 2018

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • A13102015 SoM SPMIC PhD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gastrointestinal Symptoms

Clinical Trials on Whole apples

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Greece

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe