University of Nottingham
Nottingham, NG7 2UH, United Kingdom
NCT Number: NCT03714464
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Nottingham, NG7 2UH, United Kingdom
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
350 of whole apples containing 49g of available carbohydrate with 173ml water
384g of apple puree containing 44g of available carbohydrates with 224 ml water
338g apple juice containing 46g of available carbohydrate with 260 ml water
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.
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.
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
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)
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.
University of Nottingham
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07528534
Gastrointestinal Symptoms
Osmaniye, Turkey (Türkiye)
View Trial DetailsNCT03514784
Autism Spectrum Disorder, Child Development Disorders, Pervasive
Houston, Texas, United States
View Trial DetailsNCT07464509
Bowel Habits, Gastrointestinal Symptoms
Aksaray, Turkey (Türkiye)
View Trial DetailsNCT06425094
Anxiety, Anxiety Disorders
Fort Collins, Colorado, United States
View Trial Details