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

NCT01477112 | Completed DMC

• 1 other identifier: IVIC-HUMNUT-001
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus; Oxidative Stress; Iron Metabolism Disorders

Keywords

Type 2 diabetes; β-carotene; Oxidative balance; Oxidants; Antioxidants

Outcome Measures

Primary Outcomes (1)

• Changes in oxidative status

  Time 0, 45 days and 75 days after supplementation

Secondary Outcomes (14)

• Hemoglobin and hematocrit

  Time 0, 45 days and 75 days after supplementation

• Ferritin

  Time 0, 45 days and 75 days after supplementation

• Iron metabolism markers

  Time 0, 45 days and 75 days after supplementation

• Blood Chemistry

  Time 0, 45 days and 75 days after supplementation

• Glycosylated Hemoglobin

  Time 0, 45 days and 75 days after supplementation

Study Arms (4)

Supplemented Diabetics (DB)

EXPERIMENTAL

Diabetics supplemented with betacarotene for 45 days

Dietary Supplement: Betacarotene

Unsupplemented Diabetics (DS)

EXPERIMENTAL

Diabetics without betacarotene supplementation

Dietary Supplement: Controls. No treatment

Supplemented Controls (CB)

ACTIVE COMPARATOR

Controls supplemented with betacarotene for 45 days

Dietary Supplement: Betacarotene

Unsupplemented Controls (CS)

ACTIVE COMPARATOR

Controls without betacarotene supplementation

Dietary Supplement: Controls. No treatment

Interventions

Betacarotene DIETARY_SUPPLEMENT

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

Also known as: β-carotene as a soft gel capsule (GNC, Pennsylvania-USA)

Supplemented Controls (CB); Supplemented Diabetics (DB)

Controls. No treatment DIETARY_SUPPLEMENT

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

Also known as: No supplements

Unsupplemented Controls (CS); Unsupplemented Diabetics (DS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Venezolano de Investigaciones Cientificas: lead
• Seguros Caracas Foundation: collaborator
• National Fund for Science and Technology, Science Mission: collaborator

Study Sites (1)

Hospital Baudilio Lara

Barquisimeto, Lara, Venezuela

Location

Related Publications (4)

• 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.

  PMID: 10587829 BACKGROUND

• 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.

  PMID: 12941775 BACKGROUND

• 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.

  PMID: 16537987 BACKGROUND

• 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.

  PMID: 19491386 BACKGROUND

Related Links

• American Diabetes Association

MeSH Terms

Conditions

Diabetes Mellitus; Iron Metabolism Disorders; Diabetes Mellitus, Type 2

Interventions

beta Carotene

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Study Officials

• Maria N Garcia-Casal, PhD

  Instituto Venezolano de Investigaciones Cientificas

  STUDY DIRECTOR

• Jose M Moreno, PhD

  Instituto Venezolanode Investigaciones cientificas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Pathophysiology Laboratory

Study Record Dates

• First Submitted: November 15, 2011
• First Posted: November 22, 2011
• Study Start: January 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: November 22, 2011

Record last verified: 2011-11

Locations

VE (1)