Completed

NCT Number: NCT01383902

Chocolate Meal Study

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.

Completed

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Key information

Conditions

Impact of Food Composition on Gastric Emptying

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Food Research, Norwich, Norfolk, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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).
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

Treatment and study plan

food type

Other

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

Primary outcomes

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.

Secondary outcomes

Use of MRI for measuring gastric emptying rates

Time frame: 4 hours

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.

Sponsors and collaborators

Lead sponsor

Quadram Institute Bioscience

Other

Collaborators

Norfolk and Norwich University Hospitals NHS Foundation Trust

Registry information

Official study title

The Effect of Meal Type on the Rate of Gastric Emptying

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Jun 28, 2011
Registry last updated: Jun 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.