Status:
COMPLETED
Feeding the Rainbow to Investigate Endothelial Dysfunction
Lead Sponsor:
Bastyr University
Collaborating Sponsors:
University of Washington
Conditions:
Dietary Modification
Cardiovascular Disease
Eligibility:
All Genders
18-65 years
Phase:
EARLY_PHASE1
Brief Summary
The primary purpose of this study is to compare the change in blood carotene concentration between a food-based versus nutritional supplement-based intervention. This study will randomize up to 60 hea...
Eligibility Criteria
Inclusion
- adults aged 18-65
- in good health by the absence of exclusion criteria on standardized medical history interview
- willingness to be randomized
- willingness to complete multiple blood draws following fast food consumption on two occasions over 28 days
Exclusion
- children \<18 years
- current use of carotenoid supplements (not including typical multivitamins containing beta-carotene)
- current use of polyphenol supplements including green tea, resveratrol, pine bark extract, cocoa, and/or grape skin extract
- current use of aspirin, statins or regular (\>2 per week) use of NSAID medications
- current smoking or past smoking greater than 3 packs total or currently living with a smoker
- excessive alcohol intake (\> 3 drinks per day) or history of alcoholism
- known exposure to asbestos
- autoimmune disease
- hemachromatosis
- history of gallbladder disease including gall stones or gall bladder removal
- pre-diabetes, metabolic syndrome or diabetes (1 or 2)
- established cardiovascular disease (arrhythmia, heart failure, hypertension treatment or untreated stage II hypertension (≥160/90; stage II technically diastolic ≥100mmHg, will maintain diastolic cutoff of 90mmHg), past MI or stroke)
- renal or liver disease (viral hepatitis, non-alcoholic steatohepatitis "fatty liver")
- acute infection except viral colds
- residual injury/pain/limitation from trauma
- chronic musculoskeletal disorders including osteoarthritis requiring pain medications
- psychiatric disorders that would impair completion of research tasks
- allergies to supplied foods
- anyone on a medically-prescribed diet
- \>3.5 servings fruits/veggies per day
- inability to consume entire study Control meal w/in specified timeline (30 minutes)
- current pregnancy or breast feeding
- refusal to participate in blood draws following the control meal.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01175577
Start Date
October 1 2009
End Date
August 1 2011
Last Update
February 3 2012
Active Locations (2)
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1
Bastyr University Clinical Research Center
Kenmore, Washington, United States, 98028
2
University of Washington Clinical Research Center
Seattle, Washington, United States, 98195