Impact of Food Composition on Gastric EmptyingNCT01383902
Chocolate Meal Study
A study testing Food type in people with Impact of Food Composition on Gastric Emptying, run by Quadram Institute Bioscience at 2 sites in United Kingdom.
Trial summary
This comparative pilot study is designed to compare the rates of gastric emptying and by inference rates of digestion of challenge meals. Two types of meal will be compared, chocolate mousse style dessert and chocolate bars. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Impact of Food Composition on Gastric Emptying
- What is being tested?
- Food type
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- May 2009to Nov 2009
- 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 20 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male (hormonal status of women would introduce more variation within small group)
- Age 20-50y
- BMI 19-30
- Nominally healthy
- Normally eat lunch
- Willing to eat dark chocolate bars and chocolate dessert.
- Provides informed written consent
Who cannot join
- Smokers or smoked within the last year (smoking affects satiety/hunger and volunteer's will not be able to smoke during the study day at the hospital)
- 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.
- Regular (more than once in 10 days) use of antacids, laxatives
- Diagnosis with any mouth, dental, throat or digestive problem that may affect normal eating and digestion of food.
- Volunteers taking part in another study (other than a questionnaire based study).
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- Blood pressure greater than 160/100 or less than 90/50 or 95/55 if symptomatic.
- Individuals with special dietary requirements (eg vegetarians)
- People with eating disorders (eg. anorexia, bulimia)
- 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
- Allergic to any of the constituents of the test meal
- 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
- Head surgery or 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Institute of Food Research
Norwich, Norfolk, NR4 7UA
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, Norfolk, NR4 7UY
About this study
Official title: The Effect of Meal Type on the Rate of Gastric Emptying
This comparative pilot study is designed to compare the rates of gastric emptying and by inference rates of digestion of challenge meals. Two types of meal will be compared, chocolate mousse style dessert and chocolate bars. The information from this study will then be compared to the elicitation times for both objective and subjective symptoms in the allergic patients who have been challenged in a different study using the same two meals.
- Being tested
- Food type
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food typeOther
1ml, 1ml, 5ml, 50ml, 6ml, 20ml, 60ml and 200ml of chocolate dessert or 1 g, 1 segment (5 segments to a bar) repeated 6 times, 2 bars repeated twice of chocolate bars
| Study group | Role | What they receive |
|---|---|---|
| dessert / chocolate | Other | Not described Receives: Other: Food type |
What is being measured
The primary outcome is the main question the study is designed to answer.
A series of MRI images of the abdomen giving gastric emptying and layering data
To produce gastric emptying and layering data from MRI images on healthy volunteers using a nine differing dose protocol in two different foods.
Measured: 4 hours
Secondary outcomes (1)
Use of MRI for measuring gastric emptying rates
An additional underpinning objective is to evaluate and optimise the MRI method for imaging gastric function as a reliable tool for future clinical and nutritional research.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2011 (estimated)
- Study startMay 2009
- Primary completionSep 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impact of Food Composition on Gastric EmptyingStudies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quadram Institute Bioscience
- Sponsor type
- University, hospital or other
- Collaborators
- Norfolk and Norwich University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01383902
- Sponsor's protocol ID
- IFR03/2008
- Status last verified
- Jun 2011
- First submitted
- 24 Jun 2011
- Last updated
- 28 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Meal Type on the Rate of Gastric Emptying
- ClinicalTrials.gov ID
- NCT01383902
- Acronym / sponsor ID
- IFR03/2008
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Quadram Institute BioscienceUniversity, hospital or other
- Collaborators
- Norfolk and Norwich University Hospitals NHS Foundation Trust
- Study start
- May 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 28 Jun 2011 (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.
This comparative pilot study is designed to compare the rates of gastric emptying and by inference rates of digestion of challenge meals. Two types of meal will be compared, chocolate mousse style dessert and chocolate bars. The information from this study will then be compared to the elicitation times for both objective and subjective symptoms in the allergic patients who have been challenged in a different study using the same two meals.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dessert / chocolate | Other | Other: Food type |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male (hormonal status of women would introduce more variation within small group)
- Age 20-50y
- BMI 19-30
- Nominally healthy
- Normally eat lunch
Key exclusion criteria (25 listed)
- Smokers or smoked within the last year (smoking affects satiety/hunger and volunteer's will not be able to smoke during the study day at the hospital)
- 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.
- Regular (more than once in 10 days) use of antacids, laxatives
- Diagnosis with any mouth, dental, throat or digestive problem that may affect normal eating and digestion of food.
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 |
|---|---|---|
| Food type1ml, 1ml, 5ml, 50ml, 6ml, 20ml, 60ml and 200ml of chocolate dessert or 1 g, 1 segment (5 segments to a bar) repeated 6 times, 2 bars repeated twice of chocolate bars | Other | dessert / chocolate |
Primary outcome
A series of MRI images of the abdomen giving gastric emptying and layering data
Time frame: 4 hours
To produce gastric emptying and layering data from MRI images on healthy volunteers using a nine differing dose protocol in two different foods.
1 secondary outcome
Use of MRI for measuring gastric emptying rates
Time frame: 4 hours
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 28 Jun 2011.
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food type in people with Impact of Food Composition on Gastric Emptying, run by Quadram Institute Bioscience at 2 sites in United Kingdom.
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 7 inclusion and 25 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 28 Jun 2011. 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 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?
A series of MRI images of the abdomen giving gastric emptying and layering data (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jun 2011.