MRI Study of Stomach Volumes and Satiety

This study has been completed.
Sponsor:
Collaborator:
Unilever R&D
Information provided by (Responsible Party):
University of Nottingham
ClinicalTrials.gov Identifier:
NCT01690182
First received: September 17, 2012
Last updated: December 17, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Healthy
Dietary Supplement: Study test meal 1
Dietary Supplement: Study test meal 2
Dietary Supplement: Study test meal 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Effects of Test Meal Volume and Energy Density on Gastric Volumes and Satiety Assessed by MRI

Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • Total gastric content half emptying time T50 [ Time Frame: 0 - 240 mins ] [ Designated as safety issue: No ]
    Total gastric volume at half the experimental time


Secondary Outcome Measures:
  • Volumes of test meal in the stomach [ Time Frame: 0 - 240 mins ] [ Designated as safety issue: No ]
    gastric volumes of the test meals in the stomach obtained from MRI images, as a function of time


Other Outcome Measures:
  • Relationship of gastric behaviour of test meal stomach volumes with satiety [ Time Frame: 0 - 240 minutes ] [ Designated as safety issue: No ]
    A comparison of the gastric volumes with satiety scores obtained throughout the experiment


Enrollment: 18
Study Start Date: December 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Dietary Supplement: Study test meal 1
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
Dietary Supplement: Study test meal 2
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.
Dietary Supplement: Study test meal 3
Volunteers will be fed with a low volume, high energy density test meal

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01690182

Locations
Netherlands
Unilever Research and Development
Olivier van Noortlann 120, AT Vlaardingen, Netherlands, 3133
United Kingdom
Nottingham Digestive Diseases Centre and Sir Peter Mansfield Magnetic Resonance Centre
University of Nottingham, Nottingham, United Kingdom, NG7 2RD
Sponsors and Collaborators
University of Nottingham
Unilever R&D
Investigators
Principal Investigator: Luca Marciani, PhD University of Nottingham
  More Information

No publications provided

Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT01690182     History of Changes
Other Study ID Numbers: F/11/2010
Study First Received: September 17, 2012
Last Updated: December 17, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Nottingham:
Gastrointestinal physiology
MRI
gastric volumes
satiety

ClinicalTrials.gov processed this record on September 11, 2014