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Biological Functions of Carotenoids in Humans

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00356252
First Posted: July 25, 2006
Last Update Posted: July 24, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
BASF
Information provided by:
Tufts University
  Purpose

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.


Condition Intervention
Oxidative DNA Damage Drug: mixed carotenoids

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Functional Bioavailability of Carotenoids in Humans

Further study details as provided by Tufts University:

Primary Outcome Measures:
  • DNA damage
  • plasma carotenoid concentrations

Secondary Outcome Measures:
  • lipid peroxidation
  • Total antioxidant capacity

Estimated Enrollment: 40
Study Start Date: April 2002
Estimated Study Completion Date: December 2003
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00356252


Locations
United States, Massachusetts
Jean Mayer USDA-Human Nutrition Research Center on Aging, Tufts University
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts University
BASF
Investigators
Principal Investigator: Kyung-Jin Yeum, PhD Tufts Medical Center
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00356252     History of Changes
Other Study ID Numbers: HNRCA1860
PV1087
First Submitted: July 24, 2006
First Posted: July 25, 2006
Last Update Posted: July 24, 2008
Last Verified: July 2008

Additional relevant MeSH terms:
Carotenoids
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs