Gastric Layering Study

May 4, 2012 updated by: Alan Mackie, Quadram Institute Bioscience

A Study on the Effect of Gastric Layering and Emptying Induced by a Food Emulsion

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Norfolk
      • Norwich, Norfolk, United Kingdom, NR4 7UA
        • Institute of Food Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Gastric emptying rates
Time Frame: 3 hours
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.
3 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fullness and satiety from visual analogue scores
Time Frame: 3.5 hours
To correlate gastric emptying rates with satiety responses after the meal
3.5 hours
levels of CCK in the blood
Time Frame: 3.5 hours
To correlate gastric emptying rates with levels of the GI hormone CCK in blood
3.5 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Quadram Institute Bioscience

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Norfolk and Norwich University Hospitals NHS Foundation Trust
Top Institute Food and Nutrition

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alan R Mackie, PhD, Quadram Institute Bioscience

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 28, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 7, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IFR07/2010

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings