Design of a randomized trial to determine the optimum protein intake to preserve lean body mass and to optimize response to a promyogenic anabolic agent in older men with physical functional limitation

The dietary protein allowance for older men to maintain lean body mass and muscle strength and to accrue optimal anabolic responses to promyogenic stimuli is poorly characterized. The OPTIMEN trial was designed to assess in older men with moderate physical dysfunction and insufficient habitual protein intake (<recommended dietary allowance, RDA, 0.8g·kg^-1·d^-1) the efficacy of consuming diets containing 163% RDA (1.3g·kg^-1·d^-1) for protein, compared to RDA, to increase lean mass, muscle performance, and physical function. A second aim was to determine whether increasing protein intake to 1.3 versus 0.8g·kg^-1·d^-1 would augment anabolic responses to a promyogenic agent, testosterone. For this randomized, double-blind, placebo-controlled six-month intervention trial, 92 men, 65years or older, with Short Physical Performance Battery scores 3-10, and habitual protein intakes <RDA, were assigned to one of four groups: 100% RDA plus placebo intramuscular injections weekly; 100% RDA plus weekly intramuscular injections of 100mg testosterone enanthate; 163% RDA plus placebo injections; or 163% RDA plus testosterone injections. All participants received portion-controlled packaged meals and group-specific dietary supplements containing either mixtures of casein and whey or carbohydrate, with identical appearance. The primary outcome was change in lean body mass assessed using dual energy X-ray absorptiometry. Secondary outcomes included maximal voluntary strength and power in leg press and chest press exercises, 6-minute walking distance, stair climbing power, and self-reported physical function. Results of the OPTIMEN trial have important implications for dietary protein guidance and policy, and efficacy of promyogenic drugs.