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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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Gastrointestinal Symptoms

Intervention / Treatment
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* Other: Whole apples
* Other: Apple puree
* Other: Apple Juice


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The intervention to be tested in this study is dietary intake of apples which are naturally high in fermentable carbohydrate. The investigators purchased the apples from a mainstream high street supermarket. The test meals consisted of whole apples (Meal A), apple puree (Meal B) and apple juice (Meal C)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Whole Apple<br>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<br>* 350 of whole apples containing 49g of available carbohydrate with 173ml water<br>|
| Experimental: Apple Puree<br>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<br>* 384g of apple puree containing 44g of available carbohydrates with 224 ml water<br>|
| Experimental: Apple Juice<br>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<br>* 338g apple juice containing 46g of available carbohydrate with 260 ml water<br>|

What is the study measuring?
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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. | 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. | 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 | Breath hydrogen is measured in parts per million (ppm) using a breath hydrogen meter | every 45 minutes from 0 minutes until 315 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastrointestinal physiology, Gastrointestinal response to sugars, gastrointestinal, MRI, stomach, small bowel, sorbitol, excess fructose, FODMAPs, colon