CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 31 enrolled
Drug / intervention
Whole apples +2 moreother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03714464
NCT03714464N/ACompleted

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

University of Nottingham·interventional·Posted Oct 22, 2018·Updated Oct 22, 2018

In Brief

A clinical study evaluating Whole apples, Apple puree, and 1 other intervention for Gastrointestinal Symptoms. Completed, enrolled 31 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 22, 2018
Enrollment StartFeb 1, 2016
Primary CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 7.7 years ago

Interventions

Whole applesother

350 of whole apples containing 49g of available carbohydrate with 173ml water

Apple pureeother

384g of apple puree containing 44g of available carbohydrates with 224 ml water

Apple Juiceother

338g apple juice containing 46g of available carbohydrate with 260 ml water