Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-24 @ 7:02 PM
NCT ID:
NCT01565057
Eligibility 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
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
50 Years
Study:
NCT01565057
Study Brief:
Protocol Section:
NCT01565057