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OpenTrials
Completed

NCT Number: NCT00356252

Biological Functions of Carotenoids in Humans

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.

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Key information

Conditions

Oxidative DNA Damage

Age range

50 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Jean Mayer USDA-Human Nutrition Research Center on Aging, Tufts University

Boston, Massachusetts, 02111, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

mixed carotenoids

Drug

Primary outcomes

  1. DNA damage

  2. plasma carotenoid concentrations

Secondary outcomes

  1. lipid peroxidation

  2. Total antioxidant capacity

Sponsors and collaborators

Lead sponsor

Tufts University

Other

Collaborators

  • BASF

Registry information

Official study title

Functional Bioavailability of Carotenoids in Humans

Important dates

Study start
2002
Study completion
2003
First posted
Jul 25, 2006
Registry last updated
Jul 24, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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