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Gastric Layering Study

This study has been completed.
Sponsor:
Collaborators:
Norfolk and Norwich University Hospitals NHS Foundation Trust
Top Institute Food and Nutrition
Information provided by (Responsible Party):
Alan Mackie, Institute of Food Research
ClinicalTrials.gov Identifier:
NCT01565057
First received: March 23, 2012
Last updated: May 4, 2012
Last verified: May 2012
  Purpose

This comparative study is designed to compare the gastric layering and rates of emptying and by inference rates of digestion of two food emulsions. Two types of dairy based foods will be used, one which will sediment in the stomach and one that will not. On each of two study days, a total of 9 post drink MRI scans will be taken to assess gastric layering and emptying. Cannulation will allow blood samples to be taken periodically for subsequent analysis for the presence of specific digestion related hormones. A total volume of 36 ml of blood will be removed and volunteers will also be asked to complete a questionnaire at predetermined times to assess feelings of satiation.


Condition Intervention
Healthy Volunteers
Other: sedimenting meal

Study Type: Interventional
Study Design: Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Study on the Effect of Gastric Layering and Emptying Induced by a Food Emulsion

Further study details as provided by Institute of Food Research:

Primary Outcome Measures:
  • Gastric emptying rates [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    The primary objective is to measure gastric emptying rates and layering patterns as a function of time in healthy volunteers using two different meals, one which sediments gastric digestion and one in which it does not.


Secondary Outcome Measures:
  • Fullness and satiety from visual analogue scores [ Time Frame: 3.5 hours ] [ Designated as safety issue: No ]
    To correlate gastric emptying rates with satiety responses after the meal

  • levels of CCK in the blood [ Time Frame: 3.5 hours ] [ Designated as safety issue: No ]
    To correlate gastric emptying rates with levels of the GI hormone CCK in blood


Enrollment: 10
Study Start Date: August 2011
Study Completion Date: May 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sedimenting meal
To assess whether rates of gastric emptying of a specifically formulated emulsion drink are significantly different from a control drink and that this in turn leads to differences in satiation (cessation in the desire to eat) and satiety (desire to limit further food intake) as measured by visual analogue scale (VAS) satiety questionnaire and blood CCK.
Other: sedimenting meal
The active system quickly forms a sedimenting layer of small particles that contain most of the caloric content of the system. This system is made by adding finely grated cheese (particle size 0.5-2 mm) to yoghurt and consumption is followed by drinking 327 ml water.

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male (hormonal status of women would introduce more variation within small group)
  • Age 20-50y
  • BMI 19-30
  • Apparently healthy
  • Normally eat lunch
  • Willing to eat the finely grated cheese meal
  • Provide written informed consent

Exclusion Criteria:

  • Individuals with an intolerance or allergy to any of the constituents of the test meal
  • Smokers or smoked within the last year (smoking affects satiety/hunger)
  • Diagnosed with any long term illness requiring active treatment e.g. diabetes, cancer, cardiovascular disease
  • Have had surgery on the stomach or intestine or suffered from gastrointestinal disease, whether diagnosed or self reported
  • Regular (more than once in 10 days) use of antacids, laxatives
  • Any problems with swallowing
  • Take prescription medication for digestive or gastrointestinal conditions.
  • Volunteers taking part in another study (other than a questionnaire based study).
  • Blood pressure greater than 160/100 or less than 90/50 or 95/55 if symptomatic.
  • Individuals with special dietary requirements (eg vegetarians)
  • If attended a study during the previous four months where combined blood sampling from previous study and present study would exceed 470mL.
  • If any of the clinical screening results are indicative of a health problem which would affect the volunteers well-being or which would affect the study data.
  • Refusal to give permission to inform GP of participation in study
  • Recent unexplained weight gain or loss
  • History of back problems or any other condition which limit ability to repeatedly sit up and lie down
  • Hiatus Hernia
  • MRI scanning specific exclusion criteria

    • Cardiac pacemaker or artificial heart valve
    • Any surgery in the last 6 months
    • Aneurysm clips (metal clips from surgery)
    • Implant, pump or any medical device in the body (eg cochlear implant, neurostimulator, intra-venticular shunt)
    • Worked with metals (using lathes or grinders) or sustained injury to eyes involving metal splinters or fillings
    • Have artificial eyes or limbs
    • Have been injured with shrapnel or bullets
    • Suffer from fits, blackouts or epilepsy
    • Claustrophobia sufferer
  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: NCT01565057

Locations
United Kingdom
Institute of Food Research
Norwich, Norfolk, United Kingdom, NR4 7UA
Sponsors and Collaborators
Institute of Food Research
Norfolk and Norwich University Hospitals NHS Foundation Trust
Top Institute Food and Nutrition
Investigators
Principal Investigator: Alan R Mackie, PhD Institute of Food Research
  More Information

No publications provided

Responsible Party: Alan Mackie, Principle Investigator, Institute of Food Research
ClinicalTrials.gov Identifier: NCT01565057     History of Changes
Other Study ID Numbers: IFR07/2010
Study First Received: March 23, 2012
Last Updated: May 4, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Institute of Food Research:
emulsion
emptying
protein
layering

ClinicalTrials.gov processed this record on November 27, 2014