Development of a Novel Six-Month Nutrition Intervention for a Randomized Trial in Older Men with Mobility Limitations.
Development of a Novel Six-Month Nutrition Intervention for a Randomized Trial in Older Men with Mobility Limitations.
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为行动不便的老年男性进行随机试验，开发一种新颖的为期六个月的营养干预措施。
DOI：
10.1007/s12603-017-0990-4
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发表时间：
2017
期刊：
影响因子：
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通讯作者：
Moore,LL
中科院分区：
文献类型：
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作者：
Apovian,CM;Singer,MR;Campbell,WW;Bhasin,S;McCarthy,AC;Shah,M;Basaria,S;Moore,LL
目的营养影响肌肉减少症的发生，蛋白质摄入是老年人骨骼肌质量损失的重要调节因子。优化蛋白质摄入量的老年男性行动不便（OPTIMEN）试验旨在评估较高的蛋白质摄入量和促肌生成剂睾酮对老年男性行动不便的瘦体重，肌肉力量和身体功能的独立和综合影响。本文的目的是描述实验设计和营养干预，包括研究营养师使用的技术，以开发和提供能量和蛋白质特定的膳食到社区居住的参与者的家庭。策略，以提高长期的饮食依从性进行了详细说明。安慰剂对照的六个月干预试验。设置参与者从美国马萨诸塞州波士顿和周围社区招募。（短体能测试（SPPB）3-10）和消耗更少的蛋白质（<0.83 g/kg/day）被招募用于本研究。InterventionHere，我们报告了成功实施的双盲，安慰剂对照，平行组，一项在65岁及以上行动受限的社区生活男性中进行的为期6个月的干预期随机对照试验。采用受控喂养计划，在三餐中提供所需的能量摄入量和规定的0.8或1.3克/千克/天（g/kg/d）蛋白质量，外加零食和补充剂。A 2x2析因设计被用来评估蛋白质水平的影响，并结合睾酮（与安慰剂）的变化瘦体重（主要结果），肌肉力量，和身体function.ResultsA共154名男子符合资格标准，112完成了为期2周的磨合期，旨在评估遵守营养干预。其中，92例受试者符合依从性合格标准并同意接受随机化; 85%完成了整个试验。该研究成功地为受试者提供了一日三餐，具有高度的依从性和受试者满意度。总体自我报告的膳食和补充剂的依从率分别为80%和93%。合规strategies的细节进行了讨论。ConclusionThis社区为基础的研究设计可以作为一个模型，为长期的营养干预措施，需要监测的饮食依从性在家庭为基础的喂养和补充试验。
ObjectivesNutrition 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.DesignRandomized, double-blind, placebo-controlled six-month intervention trial.SettingParticipants were recruited from Boston MA USA and surrounding communities.ParticipantsOlder 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.InterventionHere 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.ResultsA 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.ConclusionThis 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.