MRI Study of Stomach Volumes and Satiety

Healthy Clinical Trial

Official title:

Effects of Test Meal Volume and Energy Density on Gastric Volumes and Satiety Assessed by MRI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01690182
• Other study ID #: F/11/2010
• Status: Completed
• Phase: N/A
• First received: September 17, 2012
• Last updated: December 17, 2012
• Start date: December 2010
• Est. completion date: December 2012

Study information

• Verified date: December 2012
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

Inclusion criteria:

• Apparently healthy; no medical conditions that might affect the study measurements (as determined by the study physician)

• No use of medication that would interfere with the study measurements (as determined by the study physician)

• No use of antibiotics in the 3 months before the study or during the study

• No reported participation in another nutritional or biomedical trial 3 months before the study or during the study

• Being used to eating 3 meals daily

• BMI: 20 - 35 kg m-2

• No reported participation in night shift work 2 weeks prior to the study or during the study

• Not taking part in strenuous exercise =10 hours/week

• Not consuming more than 21 alcoholic test meals in a typical week

• Not presently a smoker

• No reported weight loss or gain of more than 10 % of bodyweight for 6 months before the study

• No eating disorder

• No MRI contraindications; i.e absence of metal implants, infusion pumps and pacemakers, as assessed by a MRI safety screening questionnaire

Exclusion criteria:

• High or very high restrained eater

• Use of any medically- or self-prescribed diet for the duration of the study

• Allergies or food intolerances

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Study test meal 1
Volunteers will be fed with a high volume, high energy density test meal.
• Study test meal 2
Volunteers will be fed with a high volume, low energy density test meal
• Study test meal 3
Volunteers will be fed with a low volume, high energy density test meal

Locations

Country	Name	City	State
Netherlands	Unilever Research and Development	Olivier van Noortlann 120	AT Vlaardingen
United Kingdom	Nottingham Digestive Diseases Centre and Sir Peter Mansfield Magnetic Resonance Centre	University of Nottingham	Nottingham

Sponsors (2)

Lead Sponsor	Collaborator
University of Nottingham	Unilever R&D

Countries where clinical trial is conducted

Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Relationship of gastric behaviour of test meal stomach volumes with satiety	A comparison of the gastric volumes with satiety scores obtained throughout the experiment	0 - 240 minutes	No
Primary	Total gastric content half emptying time T50	Total gastric volume at half the experimental time	0 - 240 mins	No
Secondary	Volumes of test meal in the stomach	gastric volumes of the test meals in the stomach obtained from MRI images, as a function of time	0 - 240 mins	No