Long-term beta-carotene supplementation and risk of type 2 diabetes mellitus - A randomized controlled trial

Context Recent data suggest a protective role of carotenoids in the develop ment of type 2 diabetes mellitus (DM), possibly via an antioxidant effect, but no randomized trial has directly assessed the efficacy of beta-carotene to prevent DM. Objective To determine whether long-term beta-carotene supplementation redu ces the risk of developing type 2 DM, Design, Setting, and Participants A total of 22 071 healthy US male physici ans aged 40 to 84 years in a randomized, double-blind, placebo-controlled t rial, from 1982 to 1995. More than 99% of the participants had complete fol low-up (median duration, 12 years). Intervention Subjects were randomly assigned to receive beta-carotene (50 m g on alternate days) or placebo. Main Outcome Measure Incidence of type 2 DM. Results A total of 10 756 subjects were assigned to beta-carotene and 10 71 2 to placebo. Incidence of type 2 DM did not differ between groups: 396 men in the beta-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 o f association between beta-carotene supplementation and incidence of type 2 DM persisted despite multivariate adjustment, There was no evidence of ben efit when the period of risk was subdivided into years of follow-up or incr easing duration of treatment. Conclusion In this trial of apparently healthy men, supplementation with be ta-carotene for an average of 12 years had no effect on the risk of subsequ ent type 2 DM.