Trial | NCT01477112  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    beta carotene ...

  • Study Participants

    117
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.
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.
Study Started
Jan 31
2010
Primary Completion
Dec 31
2010
Study Completion
Dec 31
2010
Last Update
Nov 22
2011
Estimate

Dietary Supplement Betacarotene

6 mg betacarotene in caplets for 45 days (daily)and reevaluate parameters 30 days after finishing supplementation

  • Other names: β-carotene as a soft gel capsule (GNC, Pennsylvania-USA)

Dietary Supplement Controls. No treatment

Evaluate at time 0, 45 days and 75 days, but without receiving betacarotene supplements

  • Other names: No supplements

Supplemented Diabetics (DB) Experimental

Diabetics supplemented with betacarotene for 45 days

Unsupplemented Diabetics (DS) Experimental

Diabetics without betacarotene supplementation

Supplemented Controls (CB) Active Comparator

Controls supplemented with betacarotene for 45 days

Unsupplemented Controls (CS) Active Comparator

Controls without betacarotene supplementation

Criteria 

Inclusion Criteria:

Patients with a diagnose of Type 2 diabetes mellitus of at least 5 years of diagnosis, in treatment with oral hypoglycemics Patients in regular control (once a month) in the Hospital

Exclusion Criteria:

Hospitalized patient
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
No Results Posted