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Biological Functions of Carotenoids in Humans

This study has been completed.
Sponsor:
Collaborator:
BASF
Information provided by:
Tufts University
ClinicalTrials.gov Identifier:
NCT00356252
First received: July 24, 2006
Last updated: July 23, 2008
Last verified: July 2008
History of Changes
  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
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Functional Bioavailability of Carotenoids in Humans

Resource links provided by NLM:

U.S. FDA Resources

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

Ages Eligible for Study:   50 Years to 70 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
Article  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT00356252     History of Changes
Other Study ID Numbers: HNRCA1860, PV1087
Study First Received: July 24, 2006
Last Updated: July 23, 2008
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 18, 2013