Caroline M. Apovian, MD, Section of Endocrinology, Diabetes, Nutrition and Weight Management, Boston Medical Center, Boston University School of Medicine, 88 East Newton Street, Robinson 4400, Boston, MA 02118, 617-638-8556 (Phone), 617-638-8599 (Fax), (
J Nutr Health Aging. 2017;21(10):1081-1088. doi: 10.1007/s12603-017-0990-4.
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 (<0.83 g/kg/day) were recruited for this study. INTERVENTION: Here we report the successful implementation of a double-blind, placebo-controlled, parallel group, randomized controlled trial with a 6-month intervention period among community-living men, age 65 years and older with a mobility limitation. A controlled feeding plan was used to deliver required energy intakes and prescribed protein quantities of 0.8 or 1.3 grams/kilogram/day (g/kg/d) in three meals plus snacks and supplements. A 2x2 factorial design was used to assess the effects of protein level alone and in combination with testosterone (vs. placebo) on changes in lean body mass (primary outcome), muscle strength, and physical function. RESULTS: A total of 154 men met the eligibility criteria; 112 completed a 2-week run-in period designed to evaluate compliance with the nutrition intervention. Of these, 92 subjects met compliance eligibility criteria and agreed to be randomized; 85% completed the full trial. The study successfully delivered three meals per day to subjects, with a high degree of compliance and subject satisfaction. Overall self-reported compliance rates were 80% and 93% for the meals and supplements, respectively. Details of compliance strategies are discussed. CONCLUSION: This community-based study design may serve as a model for longer-term nutritional interventions requiring monitoring of dietary compliance in a home-based feeding and supplementation trial.
目的:营养会影响肌肉减少症的发展,而蛋白质摄入是老年人骨骼肌质量流失的重要调节剂。优化有活动能力限制的老年人蛋白质摄入(OPTIMEN)试验旨在评估较高蛋白质摄入和促肌生成剂睾丸酮对有活动能力障碍的老年男性瘦体重、肌肉力量和身体功能的独立和联合影响。本文旨在描述实验设计和营养干预,包括研究营养师用来为社区居住参与者开发和提供特定能量和蛋白质膳食的技术。详细介绍了增强长期饮食依从性的策略。 设计:随机、双盲、安慰剂对照的六个月干预试验。 地点:参与者从美国马萨诸塞州波士顿及其周边社区招募。 参与者:本研究招募了活动能力受限的老年男性(短体功表现测试(SPPB)3-10)且蛋白质摄入量<0.83 克/公斤/天的男性。 干预:在这里,我们报告了一项成功实施的随机、双盲、安慰剂对照、平行组、有 6 个月干预期的社区居住男性、年龄 65 岁及以上、有活动能力障碍的研究。使用控制喂养计划来提供所需的能量摄入和规定的 0.8 或 1.3 克/公斤/天(g/kg/d)蛋白质量,分三顿饭加零食和补充剂。采用 2x2 析因设计来评估蛋白质水平单独和与睾丸酮(与安慰剂相比)联合对瘦体重(主要结局)、肌肉力量和身体功能变化的影响。 结果:共有 154 名男性符合入选标准;112 名完成了为期 2 周的预试验期,旨在评估对营养干预的依从性。其中,92 名受试者符合依从性入选标准并同意随机分组;85%完成了完整试验。该研究成功地每天为受试者提供三顿饭,具有高度的依从性和受试者满意度。总的自我报告依从率分别为 80%和 93%,用于膳食和补充剂。讨论了依从性策略的细节。 结论:这项基于社区的研究设计可以作为需要在家中进行喂养和补充试验中监测饮食依从性的长期营养干预的模型。
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