Status:
COMPLETED
Bioavailability Study of Different Dietary Antioxidants in Volunteers
Lead Sponsor:
Cambridge Theranostics Ltd
Conditions:
Cardiovascular Disease
Eligibility:
All Genders
20-80 years
Brief Summary
Cardiovascular disease (CVD) continues to rank high among the leading causes of morbidity and mortality in adults worldwide. While diet and increased physical activity constitute the primary preventiv...
Detailed Description
90 volunteers, who fulfill the inclusion criteria, do not meet any of the exclusion criteria, who have given written informed consent will be entered into the study. Lab assays and statistical analysi...
Eligibility Criteria
Inclusion
- Healthy, Caucasian male and female subjects 20 - 80.
- Female subjects of childbearing potential agree to undergo pregnancy tests and to use an appropriate method of contraception (i.e. oral contraceptive steroids, intrauterine device, barrier method).
- Findings within the range of clinical acceptability in medical history and physical examination, and laboratory results within the "normal ranges" for the relevant laboratory tests (unless the clinical investigator considers the deviation to be irrelevant for the purpose of the study).
- Normal vital signs, or abnormalities which the clinical investigator does not consider a disqualification for participation in the study.
- Willingness to undergo a pre-study physical examination and laboratory investigations.
- Ability to comprehend and willingness to sign both statements of informed consent (for screening and phase-related procedures).
- Non-smokers, mild to moderate smokers (≤ 10 cigarettes daily).
Exclusion
- Evidence of psychiatric disorder, antagonistic personality, poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with protocol requirements.
- History of or current compulsive alcohol abuse (\> 10 drinks weekly), or regular exposure to other substances of abuse.
- Participation in another study with an experimental drug within 4 weeks before the first administration of study medication.
- A major illness during the 3 months before commencement of the screening period.
- History of hypersensitivity to the study product or any related products.
- History of bronchial asthma.
- Relevant history or laboratory or clinical findings indicative of acute or chronic disease, likely to influence study outcome.
- Donation or loss of blood equal to or exceeding 500 ml during the 8 weeks before the first administration of study medication or donation or loss blood from 250 to 500 ml in the 6 weeks before administration of study medication or donation or loss of blood up to 250 ml in the 4 weeks before administration of study medication.
- Resting heart rate of \> 100 beats per minute or \< 45 beats per minute during the screening period, either supine or standing.
- Positive testing for HIV and hepatitis B antigens.
- History of epilepsy
- Adverse events occurring in the pre-exposure phase, judged as "severe" by the principal investigator.
- Difficulty fasting or consuming the standard meals.
- Do not tolerate vein puncture.
- On a special diet within 4 weeks prior to drug administration (e. g. liquid, protein, raw food diet).
- Drug addiction requiring treatment in the past 12 months.
- Do not agree to fully participate in wash-out period and exclude from the diet the recommended food within 4 weeks before the study start and during the study.
- Tomato intolerants
- Milk intolerants
Key Trial Info
Start Date :
September 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT01199549
Start Date
September 1 2009
End Date
September 1 2010
Last Update
September 13 2010
Active Locations (1)
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1
Babraham Research Campus
Cambridge, Cambridgeshire, United Kingdom, CB22 3AT