NCT01477112

Low Dose β-carotene Supplementation Diminishes Oxidative Stress in Type 2 Diabetics and Healthy Individuals

Effect of the Supplementation With β-carotene to Type 2 Diabetic Patients and Healthy Controls on the Iron Status and Antioxidant Capacity of Plasma

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: Instituto Venezolano de Investigaciones Cientificas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Since diabetes has multiple etiologies and oxidative stress one of the proposed mechanisms, the objective is to determine the effect of supplementation with β-carotene to type 2 diabetics and healthy individuals, on iron metabolism, oxidative balance, and antioxidant plasma capacity, using doses similar to the daily nutritional requirement.

Detailed description

Type 2 diabetes is a chronic, multifactorial disease, and oxidative stress one of the pathophysiological mechanisms associated with its appearance and development. The objective was to determine the effect of supplementation with β-carotene to type 2 diabetics and healthy individuals, on iron metabolism, oxidative balance, and antioxidant plasma capacity, using doses similar to the daily nutritional requirement. 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

• Diabetes Mellitus
• Oxidative Stress
• Iron Metabolism Disorders

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Betacarotene	6 mg betacarotene in caplets for 45 days (daily)and reevaluate parameters 30 days after finishing supplementation
DIETARY_SUPPLEMENT	Controls. No treatment	Evaluate at time 0, 45 days and 75 days, but without receiving betacarotene supplements

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2011-11-22
• Last updated: 2011-11-22

Locations

1 site across 1 country: Venezuela