Trials / Completed
CompletedNCT03714464
Effect of Physical Form of Apples on Gastrointestinal Function and Satiety: a MRI Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 31 (actual)
- Sponsor
- University of Nottingham · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
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
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Whole apples | 350 of whole apples containing 49g of available carbohydrate with 173ml water |
| OTHER | Apple puree | 384g of apple puree containing 44g of available carbohydrates with 224 ml water |
| OTHER | Apple Juice | 338g apple juice containing 46g of available carbohydrate with 260 ml water |
Timeline
- Start date
- 2016-02-01
- Primary completion
- 2016-08-01
- Completion
- 2016-08-01
- First posted
- 2018-10-22
- Last updated
- 2018-10-22
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT03714464. Inclusion in this directory is not an endorsement.