Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT03714464
Study type Interventional
Source University of Nottingham
Contact
Status Completed
Phase N/A
Start date February 2016
Completion date August 2016

See also
  Status Clinical Trial Phase
Completed NCT05831527 - An Exploratory Investigation of a Supplement to Promote Gut Health N/A
Completed NCT03659747 - Effect of Probiotic Supplementation on Lactose Maldigestion Induced by Fat-free Milk N/A
Recruiting NCT05972291 - Mechanisms of Gulf War Illness N/A
Completed NCT02054455 - Proton Pump Inhibitors and Gastrointestinal Symptoms Phase 4
Completed NCT03959722 - The Effect of Probiotics on GI Symptoms N/A
Recruiting NCT03514784 - Combination Probiotic: BB-12 With LGG (Different Doses) in Treating Children With Autism Spectrum Disorder Phase 1/Phase 2
Completed NCT01927900 - The Effects Of HMO On The Faecal Microbiota And On Gastrointestinal Symptoms In Healthy Volunteers N/A
Recruiting NCT04919265 - Mother-Infant Cohort Study in Malaysia and China
Completed NCT01171014 - Effect of Bifidobacterium Lactis HN019 on Colonic Transit Time and Digestive Symptoms Phase 2/Phase 3
Completed NCT00574197 - Enteric-coated Mycophenolate Sodium (Myfortic®) in Heart Transplant Recipients Phase 4
Recruiting NCT03403387 - Effects of GlutenShield, a Prebiotic, Probiotic, and Enzyme Supplement, on the Gut Microbiome of Adults With GI Symptoms N/A
Completed NCT01964599 - Potato Fiber and Gastrointestinal Function: Phase 3 N/A
Recruiting NCT06248177 - Probiotic Effect on Gastrointestinal Symptoms (FLORABIOTIC REFUERZO). N/A
Withdrawn NCT04228003 - Pendulum D2D Glucose Control for Adults With Type 2 Diabetes N/A
Recruiting NCT06425094 - Effects of a Microalgae Extract Dietary Supplement on Gut Health, Anxiety, and Immune Function Phase 1
Active, not recruiting NCT03696953 - The Efficacy of Probiotics to Reduce Antepartum Group B Streptococcus Colonization. Phase 2
Completed NCT02277431 - Probiotic Supplementation Among Adults With Recurrent Gastrointestinal Symptoms Phase 2/Phase 3
Completed NCT00677378 - Transient Receptor Potential Vanilloid One (TRPV1) Receptor Expression in Children With Retrosternal Pain N/A
Completed NCT03685552 - Safety Evaluation of a Diet and Nutritional Supplementation Program- Purify 2.0 N/A
Completed NCT01184456 - A Controlled Trial to Evaluate the Effects of GanedenBC30 on the Immune System Phase 2