NCT00356252

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2002

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 25, 2006

Completed
Last Updated

July 24, 2008

Status Verified

July 1, 2008

First QC Date

July 24, 2006

Last Update Submit

July 23, 2008

Conditions

Oxidative DNA Damage

Outcome Measures

Primary Outcomes (2)

  • DNA damage

  • plasma carotenoid concentrations

Secondary Outcomes (2)

  • lipid peroxidation

  • Total antioxidant capacity

Interventions

mixed carotenoidsDRUG

Eligibility Criteria

Age50 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Boston, Massachusetts, 02111, United States

Location

Related Publications (1)

  • Zhao X, Aldini G, Johnson EJ, Rasmussen H, Kraemer K, Woolf H, Musaeus N, Krinsky NI, Russell RM, Yeum KJ. Modification of lymphocyte DNA damage by carotenoid supplementation in postmenopausal women. Am J Clin Nutr. 2006 Jan;83(1):163-9. doi: 10.1093/ajcn/83.1.163.

    PMID: 16400064RESULT

Related Links

Study Officials

  • Kyung-Jin Yeum, PhD

    Tufts Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 24, 2006

First Posted

July 25, 2006

Study Start

April 1, 2002

Study Completion

December 1, 2003

Last Updated

July 24, 2008

Record last verified: 2008-07

Locations

US(1)