Development of a novel six-month nutrition intervention for a randomized trial in older men with mobility limitations

Objectives Nutrition impacts the development of sarcopenia and protein intake is an important modulator of skeletal muscle mass loss in older people. The Optimizing Protein Intake in Older Men with Mobility Limitation (OPTIMEN) Trial was designed to assess the independent and combined effects of higher protein intake and a promyogenic agent, testosterone, on lean body mass, muscle strength and physical function in older men with mobility disability. The purpose of this paper is to describe the experimental design and nutrition intervention, including techniques used by research dietitians to develop and deliver energy and protein-specific meals to the homes of community-dwelling participants. Strategies to enhance long-term dietary compliance are detailed. Design Randomized, double-blind, placebo-controlled six-month intervention trial. Setting Participants were recruited from Boston MA USA and surrounding communities. Participants Older men who were mobility-limited (Short Physical Performance Battery (SPPB) 3-10) and consuming less protein (