MRI Study of Stomach Volumes and Satiety

NCT ID: NCT01690182

Last Updated: 2012-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2012-12-31

Brief Summary

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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

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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.

Conditions

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Healthy

Keywords

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Gastrointestinal physiology MRI gastric volumes satiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Group Type EXPERIMENTAL

Study test meal 1

Intervention Type DIETARY_SUPPLEMENT

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

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

Group Type EXPERIMENTAL

Study test meal 2

Intervention Type DIETARY_SUPPLEMENT

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

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.

Group Type EXPERIMENTAL

Study test meal 3

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Study test meal 1

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

Intervention Type DIETARY_SUPPLEMENT

Study test meal 2

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

Intervention Type DIETARY_SUPPLEMENT

Study test meal 3

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Unilever R&D

INDUSTRY

Sponsor Role collaborator

University of Nottingham

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luca Marciani, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nottingham

Locations

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Unilever Research and Development

Olivier Van Noortlann 120, AT Vlaardingen, Netherlands

Site Status

Nottingham Digestive Diseases Centre and Sir Peter Mansfield Magnetic Resonance Centre

University of Nottingham, Nottingham, United Kingdom

Site Status

Countries

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Netherlands United Kingdom

References

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Murray K, Placidi E, Schuring EA, Hoad CL, Koppenol W, Arnaudov LN, Blom WA, Pritchard SE, Stoyanov SD, Gowland PA, Spiller RC, Peters HP, Marciani L. Aerated drinks increase gastric volume and reduce appetite as assessed by MRI: a randomized, balanced, crossover trial. Am J Clin Nutr. 2015 Feb;101(2):270-8. doi: 10.3945/ajcn.114.096974. Epub 2014 Dec 3.

Reference Type DERIVED
PMID: 25646323 (View on PubMed)

Other Identifiers

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F/11/2010

Identifier Type: -

Identifier Source: org_study_id