Cardiovascular Disease, Dietary Modification
Conditions
Keywords
mixed carotenes
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 healthy volunteers to receive either carotenoid-enriched food; natural, mixed carotenoid supplementation; chlorophyll complex or placebo supplementation. Blood carotene levels will be measured before and after 28 days of supplementation. Preliminary data will also be collected on several biomarkers associated with vascular inflammation and endothelial dysfunction. These biomarkers will be measured before and during a fast food control meal at the beginning and end of the intervention period.
Interventions
DIETARY_SUPPLEMENTChlorophyll complex, Standard Process
One capsule, twice daily with meals for 28 days
DIETARY_SUPPLEMENTBetatene, sold as Full Spectrum Carotenoid Complex
One capsule per day with meals for 28 days
OTHERSmall carotenoid-rich meals
Single carotenoid-enriched soup or salad serving eaten daily
OTHERPlacebo
Safflower oil-filled capsules, one twice daily with meals
Sponsors
University of Washington
Bastyr University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in serum carotenoid fraction concentrations between study arms | Following 28 day intervention |
Secondary
| Measure | Time frame |
|---|---|
| Change in serum gamma-glutamyl transferase (GGT) | Following 28 day intervention |
| Change in urinary isoprostanes | Following 28 day intervention |
| Change in oxidized LDL lipoproteins (oxLDL) | Following 28 day intervention |
| Change in lipid profile (LDL, HDL, triglycerides) | Following 28 day intervention |
| Change in C-reactive protein (CRP) | Following 28 day intervention |
| Change in serum antioxidant capacity (ORAC) | Following 28 day intervention |
Countries
United States
Outcome results
None listed