Ketogenic Feeding to Preserve Muscle Mass in Middle-aged and Older Trauma Injury Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events
研究概览
简要总结
The purpose of this study is to determine whether a ketogenic diet, provided as tube feeding, compared with a standard hospital tube feeding, is safe and feasible and helps preserve muscle mass and improve metabolic health in adults aged 55 years and older hospitalized with traumatic injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 55 years and older
- •Traumatic injury
- •Expected to survive and at least 10-day stay in the hospital
- •Expected to be enterally fed for at least 10 days
- •Willingness to be randomized to either treatment group
- •Willingness to participate in all study procedures
排除标准
- •Failure to provide informed consent
- •Vegeterian/vegan
- •Diagnosed dementia
- •Hip fracture, hip or knee replacement, or spinal surgery within past 4 months
- •Simultaneous participation in another intervention trial
研究组 & 干预措施
Ketogenic feeding
The ketogenic feeding will have a macronutrient composition of approximately 10% energy from carbohydrates, 25% energy from protein, and 65% energy from fat.
干预措施: Ketogenic feeding (Behavioral)
Standard feeding
The participant will receive standard hospital care feeding.
干预措施: Standard feeding (Behavioral)
结局指标
主要结局
Incidence of Adverse Events
时间窗: At baseline and 10-day of feeding
Number of adverse events collected using a standardized adverse event reporting form (Unit: Count of events).
Adherence to the Intervention
时间窗: From baseline to 10 days follow-up.
Percentage of prescribed intervention sessions completed, assessed through adherence logs and system usage records (Unit: %)
次要结局
未报告次要终点
研究者
Robert T Mankowski
Associate Professor
University of Alabama at Birmingham