Functional Bioavailability of Carotenoids in Humans
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tufts University
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- plasma carotenoid concentrations
Study Overview
Brief Summary
This study will examine the the efficiency fo absorption of major plant pigments, carotenoids, (lutein, beta-carotene and lycopene)and will measure the biological functions of carotenoids in healthy women in response to an 8-week period of carotenoid supplementation.
The antioxidant capacity (in both the aqueous and lipid compartments), DNA oxidation (single cell gel electrophoresis), Insulin-like Growth Factor (IGF-1), Insulin-like Growth Factor Binding Protein-3 (IGFBP-3), (gene expression profile (high-density filter-based cDNA microarrays), lipid peroxidation (MDA analysis and Isoprostane determination), and antioxidant nutrient levels (carotenoids, tocopherols, ascorbic acid and uric acid) in the circulation will be measured every other week throughout the study period.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- Double
Eligibility Criteria
- Ages
- 50 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •normal hematologic parameters, normal serum albumin, normal liver function, normal kidney function, absence of fat malabsorption and no drug intake which would interfere with fat absorption, metabolism or blood clotting.
Exclusion Criteria
- •Subjects with a history of kidney stones, active small bowel disease or resection, atrophic gastritis, hyperlipidemia, insulin-requiring diabetes, alcoholism, pancreatic disease, or bleeding disorders. Exogenous hormone users, smokers. Subjects weighing greater than 20% above or below the NHANES median standard.
Outcomes
Primary Outcomes
plasma carotenoid concentrations
DNA damage
Secondary Outcomes
- lipid peroxidation
- Total antioxidant capacity