MRI Study of Stomach Volumes and Satiety

December 17, 2012 updated by: University of Nottingham

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

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • AT Vlaardingen
      • Olivier van Noortlann 120, AT Vlaardingen, Netherlands, 3133
        • Unilever Research and Development
    • Nottingham
      • University of Nottingham, Nottingham, United Kingdom, NG7 2RD
        • Nottingham Digestive Diseases Centre and Sir Peter Mansfield Magnetic Resonance Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Volunteers will be fed with a high volume, high energy density test meal.
Experimental: 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
Volunteers will be fed with a high volume, low energy density test meal
Experimental: 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.
Volunteers will be fed with a low volume, high energy density test meal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total gastric content half emptying time T50
Time Frame: 0 - 240 mins
Total gastric volume at half the experimental time
0 - 240 mins

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volumes of test meal in the stomach
Time Frame: 0 - 240 mins
gastric volumes of the test meals in the stomach obtained from MRI images, as a function of time
0 - 240 mins

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationship of gastric behaviour of test meal stomach volumes with satiety
Time Frame: 0 - 240 minutes
A comparison of the gastric volumes with satiety scores obtained throughout the experiment
0 - 240 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

September 17, 2012

First Submitted That Met QC Criteria

September 17, 2012

First Posted (Estimate)

September 21, 2012

Study Record Updates

Last Update Posted (Estimate)

December 18, 2012

Last Update Submitted That Met QC Criteria

December 17, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • F/11/2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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