Low Dose β-carotene Supplementation Diminishes Oxidative Stress in Type 2 Diabetics and Healthy Individuals
NCT ID: NCT01477112
Last Updated: 2011-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
117 participants
INTERVENTIONAL
2010-01-31
2010-12-31
Brief Summary
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Detailed Description
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A total of 117 volunteers participated in the study. Type 2 diabetics (34) and healthy individuals (24), received 6 mg β-carotene for 45 d, and were compared to similar non-supplemented diabetic (33) and control (26) groups. Blood samples were taken at the beginning, end and 30 days after finishing supplementation, to determine hemoglobin, hematocrit unsaturated iron binding capacity, total iron binding capacity, transferrin saturation, ferritin, glycemia, glycosylated hemoglobin, cholesterol, triglycerides, HDL, LDL, oxidized LDL, copper, zinc, TBARS, FRAP, nitrites, GPx, SOD, folates, retinol and β-carotene.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Supplemented Diabetics (DB)
Diabetics supplemented with betacarotene for 45 days
Betacarotene
6 mg betacarotene in caplets for 45 days (daily)and reevaluate parameters 30 days after finishing supplementation
Unsupplemented Diabetics (DS)
Diabetics without betacarotene supplementation
Controls. No treatment
Evaluate at time 0, 45 days and 75 days, but without receiving betacarotene supplements
Supplemented Controls (CB)
Controls supplemented with betacarotene for 45 days
Betacarotene
6 mg betacarotene in caplets for 45 days (daily)and reevaluate parameters 30 days after finishing supplementation
Unsupplemented Controls (CS)
Controls without betacarotene supplementation
Controls. No treatment
Evaluate at time 0, 45 days and 75 days, but without receiving betacarotene supplements
Interventions
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Betacarotene
6 mg betacarotene in caplets for 45 days (daily)and reevaluate parameters 30 days after finishing supplementation
Controls. No treatment
Evaluate at time 0, 45 days and 75 days, but without receiving betacarotene supplements
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Diabetic patient with diabetes related acute complications (ketoacidosis, hyperosmolar coma)in the 3 months previous to the study.
* Individuals with infections that required antibiotics in the 3 weeks previous to the study.
* Individuals with antibodies anti-insulin, autoimmune diseases or in treatment with immunosuppressive drugs.
* Individuals with viral infections such as hepatitis B, hematological, renal or hepatic diseases.
* Pregnancy
18 Years
ALL
Yes
Sponsors
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Seguros Caracas Foundation
UNKNOWN
National Fund for Science and Technology, Science Mission
UNKNOWN
Instituto Venezolano de Investigaciones Cientificas
OTHER
Responsible Party
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Maria Nieves Garcia-Casal
Director of Pathophysiology Laboratory
Principal Investigators
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Maria N Garcia-Casal, PhD
Role: STUDY_DIRECTOR
Instituto Venezolano de Investigaciones Cientificas
Jose M Moreno, PhD
Role: PRINCIPAL_INVESTIGATOR
Instituto Venezolanode Investigaciones cientificas
Locations
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Hospital Baudilio Lara
Barquisimeto, Lara, Venezuela
Countries
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References
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Ford ES, Cogswell ME. Diabetes and serum ferritin concentration among U.S. adults. Diabetes Care. 1999 Dec;22(12):1978-83. doi: 10.2337/diacare.22.12.1978.
Ford ES, Mokdad AH, Giles WH, Brown DW. The metabolic syndrome and antioxidant concentrations: findings from the Third National Health and Nutrition Examination Survey. Diabetes. 2003 Sep;52(9):2346-52. doi: 10.2337/diabetes.52.9.2346.
Sugiura M, Nakamura M, Ikoma Y, Yano M, Ogawa K, Matsumoto H, Kato M, Ohshima M, Nagao A. The homeostasis model assessment-insulin resistance index is inversely associated with serum carotenoids in non-diabetic subjects. J Epidemiol. 2006 Mar;16(2):71-8. doi: 10.2188/jea.16.71.
Song Y, Cook NR, Albert CM, Van Denburgh M, Manson JE. Effects of vitamins C and E and beta-carotene on the risk of type 2 diabetes in women at high risk of cardiovascular disease: a randomized controlled trial. Am J Clin Nutr. 2009 Aug;90(2):429-37. doi: 10.3945/ajcn.2009.27491. Epub 2009 Jun 2.
Related Links
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American Diabetes Association
Other Identifiers
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IVIC-HUMNUT-001
Identifier Type: -
Identifier Source: org_study_id