Biological Functions of Carotenoids in Humans

Not Applicable

Completed

• Conditions: Oxidative DNA Damage

• Registration Number: NCT00356252
• Lead Sponsor: Tufts University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-04
• Study Completion: 2003-12
• Study First Submitted: 2006-07-24
• Study First Submitted QC: 2006-07-24
• Study First Posted: 2006-07-25
• Status Verified: 2008-07
• Last Update Submitted: 2008-07-23
• Last Update Posted: 2008-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
plasma carotenoid concentrations
DNA damage

Secondary Outcome Measures

Name	Time	Method
lipid peroxidation
Total antioxidant capacity

Trial Locations

Locations (1)

Jean Mayer USDA-Human Nutrition Research Center on Aging, Tufts University; 🇺🇸 Boston, Massachusetts, United States