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Long-term  -Carotene Supplementation and Risk of Type 2 Diabetes Mellitus
A Randomized Controlled Trial
Simin Liu, MD, ScD;
Umed Ajani, MBBS;
Claudia Chae, MD;
Charles Hennekens, MD, DrPH;
Julie E. Buring, ScD;
JoAnn E. Manson, MD, DrPH
JAMA. 1999;282:1073-1075.
Context Recent data suggest a protective role of carotenoids in the development of type 2 diabetes mellitus (DM), possibly via an antioxidant effect, but no randomized trial has directly assessed the efficacy of  -carotene to prevent DM.
Objective To determine whether long-term -carotene supplementation reduces the risk of developing type 2 DM.
Design, Setting, and Participants A total of 22,071 healthy US male physicians aged 40 to 84 years in a randomized, double-blind, placebo-controlled trial, from 1982 to 1995. More than 99% of the participants had complete follow-up (median duration, 12 years).
Intervention Subjects were randomly assigned to receive -carotene (50 mg on alternate days) or placebo.
Main Outcome Measure Incidence of type 2 DM.
Results A total of 10,756 subjects were assigned to -carotene and 10,712 to placebo. Incidence of type 2 DM did not differ between groups: 396 men in the -carotene group and 402 men in the placebo group developed type 2 DM (relative risk, 0.98; 95% confidence interval, 0.85-1.12). The lack of association between -carotene supplementation and incidence of type 2 DM persisted despite multivariate adjustment. There was no evidence of benefit when the period of risk was subdivided into years of follow-up or increasing duration of treatment.
Conclusion In this trial of apparently healthy men, supplementation with -carotene for an average of 12 years had no effect on the risk of subsequent type 2 DM.
Author Affiliations: Division of Preventive Medicine (Drs Liu, Ajani, Chae, Hennekens, Buring, and Manson) and Channing Laboratory (Dr Manson), Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Department of Ambulatory Care and Prevention (Drs Hennekens and Buring), Harvard Medical School; Departments of Epidemiology (Drs Liu, Hennekens, Buring, and Manson) and Nutrition (Dr Liu), Harvard School of Public Health; Cardiology Division, Massachusetts General Hospital (Dr Chae), Boston
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