MRI Study of Stomach Volumes and Satiety

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Study test meal 1; Dietary Supplement: Study test meal 3; Dietary Supplement: Study test meal 2

• Registration Number: NCT01690182
• Lead Sponsor: University of Nottingham

Brief Summary

The GI MRI Research group at the University of Nottingham has been developing new, non-invasive magnetic resonance imaging (MRI) techniques to image the gastrointestinal tract. In collaboration with food manufacturer Unilever, the investigators want to image the abdomen of healthy volunteers after consumption of test meals of varying volume and energy density to determine levels of gastric distension and investigate possible correlations of this with the subjects' sense of satiety.

Detailed Description

The tone of the proximal stomach decreases on meal intake through a process of gastric accommodation, aimed at increasing the capacity of the stomach. An increased gastric volume progressively distends the stomach, and this distension has been shown to have an inverse relationship on appetite. The link is assumed to be based on activation of mechanoreceptors lying in the walls of the stomach. On activation, vagal discharges are triggered, leading to activation of hypothalamic neurons and regulation of feelings of satiety. Gasrtric emptying is also regulated by duodenal feedback mechanisms triggered by the arrival and amount of nutrients.

Based on current knowledge, a high volume test meal would be expected to produce more gastric distension and satiety over a low volume test meal, and a low energy density food would be expected to empty from the stomach faster than a high energy density food. Going on this premise, study test meal 2 would be expected to empty faster than study test meal 1. These phenomena will be investigated using non invasive Magnetic Resonance Imaging (MRI) methods. MRI can measure gastric volumes serially and non-invasively with high spatial resolution. Ultimately, the findings from this study will provide novel insights on mechanisms of gastric distension and satiety.

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2012-09-17
• Study First Submitted QC: 2012-09-17
• Study First Posted: 2012-09-21
• Status Verified: 2012-12
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Last Update Submitted: 2012-12-17
• Last Update Posted: 2012-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Study test meal 1	Study test meal 1	High volume, high energy density test meal. Volunteers will be given 490 mL of a high energy test meal once in the morning
Study test meal 3	Study test meal 3	A low volume, high energy test meal. Volunteers will be given 140 mL high energy density test meal once in the morning.
Study test meal 2	Study test meal 2	High volume, low energy density test meal. Volunteers will be given 490 mL of a high volume low energy density test meal once in the morning

Primary Outcome Measures

Name	Time	Method
Total gastric content half emptying time T50	0 - 240 mins	Total gastric volume at half the experimental time

Secondary Outcome Measures

Name	Time	Method
Volumes of test meal in the stomach	0 - 240 mins	gastric volumes of the test meals in the stomach obtained from MRI images, as a function of time

Trial Locations

Locations (2)

Unilever Research and Development; 🇳🇱 Olivier van Noortlann 120, AT Vlaardingen, Netherlands

Nottingham Digestive Diseases Centre and Sir Peter Mansfield Magnetic Resonance Centre; 🇬🇧 University of Nottingham, Nottingham, United Kingdom