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

July 24, 2006
July 23, 2008
April 2002
Not Provided
  • DNA damage
  • plasma carotenoid concentrations
Same as current
Complete list of historical versions of study NCT00356252 on ClinicalTrials.gov Archive Site
  • lipid peroxidation
  • Total antioxidant capacity
Same as current
Not Provided
Not Provided
 
Biological Functions of Carotenoids in Humans
Functional Bioavailability 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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Oxidative DNA Damage
Drug: mixed carotenoids
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
December 2003
Not Provided

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.
Female
50 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00356252
HNRCA1860, PV1087
Not Provided
Not Provided
Tufts University
BASF
Principal Investigator: Kyung-Jin Yeum, PhD Tufts Medical Center
Tufts University
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP