A Phase I Randomized Clinical Trial of In-hospital and Post-hospital Whey Protein vs. Low Quality Protein vs. Isocaloric Placebo Supplementation to Improve Recovery From Hospitalization in Older Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 4
- 主要终点
- Physical Function
研究概览
简要总结
The purpose of the study is to determine the feasibility of nutritional interventions designed to help older patients maintain physical function after being in the hospital. We will test the feasibility and effect of nutritional interventions with whey protein, collagen or placebo on functional recovery from hospitalization in community dwelling older adults.
详细描述
We will compare in a randomized parallel design double blind pilot phase I study the feasibility of whey protein vs. collagen vs. isocaloric placebo supplementation in older adults during an acute hospitalization for a medical condition, and the treatments' effect size on physical function after hospital discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 65 years or older.
- •Admitted to UTMB hospital for any acute medical condition
- •English speaking
排除标准
- •Inability to consent
- •Bed or wheelchair bound prior to hospitalization
- •Estimated creatinine clearance 20 ml/min or less, or end stage renal disease not on dialysis
- •AST/ALT 2.5 times above the normal limit
- •Active cancer
- •Palliative care/Hospice
- •Estimated protein intake >1.2 g/kg/day during the previous 24 hours
- •Any other condition or event considered exclusionary by the PI and faculty physician
结局指标
主要结局
Physical Function
时间窗: Change from baseline to 30 days after discharge
Short Physical Performance Battery (SPPB) scale, 0-12 points. 0=disabled; 12=high performance
次要结局
未报告次要终点