- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01690182
MRI Study of Stomach Volumes and Satiety
Effects of Test Meal Volume and Energy Density on Gastric Volumes and Satiety Assessed by MRI
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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AT Vlaardingen
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Olivier van Noortlann 120, AT Vlaardingen, Netherlands, 3133
- Unilever Research and Development
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-
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Nottingham
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University of Nottingham, Nottingham, United Kingdom, NG7 2RD
- Nottingham Digestive Diseases Centre and Sir Peter Mansfield Magnetic Resonance Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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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