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

Instituto Venezolano de Investigaciones Cientificas

Status: Completed

Conditions: Diabetes Mellitus; Oxidative Stress; Iron Metabolism Disorders

Treatments: Dietary Supplement: Controls. No treatment; Dietary Supplement: Betacarotene

Study type: Interventional

Funder types: Other

Identifiers

NCT01477112

IVIC-HUMNUT-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 117 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

117 participants in 4 patient groups

Supplemented Diabetics (DB)

Experimental group

Description:

Diabetics supplemented with betacarotene for 45 days

Treatment:

Dietary Supplement: Betacarotene

Unsupplemented Diabetics (DS)

Experimental group

Description:

Diabetics without betacarotene supplementation

Treatment:

Dietary Supplement: Controls. No treatment

Supplemented Controls (CB)

Active Comparator group

Description:

Controls supplemented with betacarotene for 45 days

Treatment:

Dietary Supplement: Betacarotene

Unsupplemented Controls (CS)

Active Comparator group

Description:

Controls without betacarotene supplementation

Treatment:

Dietary Supplement: Controls. No treatment