HealthyNCT01690182
MRI Study of Stomach Volumes and Satiety
A study testing Study test meal 1, Study test meal 2 and Study test meal 3 in people with Healthy, run by University of Nottingham at 2 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Study test meal 1, Study test meal 2 and Study test meal 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Dec 2010to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- High or very high restrained eater
- Use of any medically- or self-prescribed diet for the duration of the study
- Allergies or food intolerances
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Netherlands1 site
Unilever Research and Development
Olivier Van Noortlann 120, AT Vlaardingen, 3133
United Kingdom1 site
Nottingham Digestive Diseases Centre and Sir Peter Mansfield Magnetic Resonance Centre
University of Nottingham, Nottingham, NG7 2RD
About this study
Official title: Effects of Test Meal Volume and Energy Density on Gastric Volumes and Satiety Assessed by MRI
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Study test meal 1, Study test meal 2, Study test meal 3
- Keywords
- Gastrointestinal physiology, MRI, gastric volumes, satiety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study test meal 1Dietary supplement
Volunteers will be fed with a high volume, high energy density test meal.
Study test meal 2Dietary supplement
Volunteers will be fed with a high volume, low energy density test meal
Study test meal 3Dietary supplement
Volunteers will be fed with a low volume, high energy density test meal
| Study group | Role | What they receive |
|---|---|---|
| Study test meal 1 | Experimental | High volume, high energy density test meal. Volunteers will be given 490 mL of a high energy test meal once in the morning Receives: Dietary Supplement: Study test meal 1 |
| Study test meal 2 | Experimental | 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 Receives: Dietary Supplement: Study test meal 2 |
| Study test meal 3 | Experimental | A low volume, high energy test meal. Volunteers will be given 140 mL high energy density test meal once in the morning. Receives: Dietary Supplement: Study test meal 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total gastric content half emptying time T50
Total gastric volume at half the experimental time
Measured: 0 - 240 mins
Secondary outcomes (1)
Volumes of test meal in the stomach
gastric volumes of the test meals in the stomach obtained from MRI images, as a function of time
Measured: 0 - 240 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2012 (estimated)
- Study startDec 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Unilever R&D
- Responsible party
- Sponsor
- Investigators
- Luca Marciani, PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01690182
- Sponsor's protocol ID
- F/11/2010
- Status last verified
- Dec 2012
- First submitted
- 17 Sep 2012
- Last updated
- 18 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25646323
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Test Meal Volume and Energy Density on Gastric Volumes and Satiety Assessed by MRI
- ClinicalTrials.gov ID
- NCT01690182
- Acronym / sponsor ID
- F/11/2010
- Conditions
- Healthy
- Keywords
- Gastrointestinal physiology, MRI, gastric volumes, satiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Unilever R&D
- Study start
- Dec 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 21 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study test meal 1 | Experimental | Dietary Supplement: Study test meal 1High volume, high energy density test meal. Volunteers will be given 490 mL of a high energy test meal once in the morning |
| Study test meal 2 | Experimental | Dietary Supplement: Study test meal 2High 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 |
| Study test meal 3 | Experimental | Dietary Supplement: Study test meal 3A low volume, high energy test meal. Volunteers will be given 140 mL high energy density test meal once in the morning. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (3 listed)
- High or very high restrained eater
- Use of any medically- or self-prescribed diet for the duration of the study
- Allergies or food intolerances
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study test meal 1Volunteers will be fed with a high volume, high energy density test meal. | Dietary supplement | Study test meal 1 |
| Study test meal 2Volunteers will be fed with a high volume, low energy density test meal | Dietary supplement | Study test meal 2 |
| Study test meal 3Volunteers will be fed with a low volume, high energy density test meal | Dietary supplement | Study test meal 3 |
Primary outcome
Total gastric content half emptying time T50
Time frame: 0 - 240 mins
Total gastric volume at half the experimental time
1 secondary outcome
Volumes of test meal in the stomach
Time frame: 0 - 240 mins
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2012.
- Derived from this study: PubMed 25646323Murray 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luca Marciani, PhD principal investigator
University of Nottingham
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study test meal 1, Study test meal 2 and Study test meal 3 in people with Healthy, run by University of Nottingham at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total gastric content half emptying time T50 (time frame: 0 - 240 mins). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01690182, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2012.