Feeding the Rainbow to Investigate Endothelial Dysfunction
NCT ID: NCT01175577
Last Updated: 2012-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
60 participants
INTERVENTIONAL
2009-10-31
2011-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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Supplement 1
Chlorophyll complex, Standard Process
One capsule, twice daily with meals for 28 days
Supplement 2
Betatene, sold as "Full Spectrum Carotenoid Complex"
One capsule per day with meals for 28 days
Food-based Intervention
Small carotenoid-rich meals
Single carotenoid-enriched soup or salad serving eaten daily
Placebo
Placebo
Safflower oil-filled capsules, one twice daily with meals
Interventions
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Chlorophyll complex, Standard Process
One capsule, twice daily with meals for 28 days
Betatene, sold as "Full Spectrum Carotenoid Complex"
One capsule per day with meals for 28 days
Small carotenoid-rich meals
Single carotenoid-enriched soup or salad serving eaten daily
Placebo
Safflower oil-filled capsules, one twice daily with meals
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* willingness to complete multiple blood draws following fast food consumption on two occasions over 28 days
* 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.
18 Years
65 Years
ALL
Yes
Sponsors
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University of Washington
OTHER
Bastyr University
OTHER
Responsible Party
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Ryan David Bradley
Research Assistant Professor
Principal Investigators
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Ryan D Bradley, ND, MPH
Role: PRINCIPAL_INVESTIGATOR
Bastyr University
Locations
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Bastyr University Clinical Research Center
Kenmore, Washington, United States
University of Washington Clinical Research Center
Seattle, Washington, United States
Countries
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Other Identifiers
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SP
Identifier Type: -
Identifier Source: org_study_id
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