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Completed

NCT Number: NCT01690182

MRI Study of Stomach Volumes and Satiety

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.

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Unilever Research and Development, Olivier Van Noortlann 120, AT Vlaardingen, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Study test meal 1

Dietary Supplement

Volunteers will be fed with a high volume, high energy density test meal.

Study test meal 2

Dietary Supplement

Volunteers will be fed with a high volume, low energy density test meal

Study test meal 3

Dietary Supplement

Volunteers will be fed with a low volume, high energy density test meal

Primary outcomes

  1. Total gastric content half emptying time T50

    Time frame: 0 - 240 mins

    Total gastric volume at half the experimental time

Secondary outcomes

  1. 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

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Collaborators

  • Unilever R&D

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Sep 21, 2012
Registry last updated
Dec 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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.

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