NCT07753239尚未招募不适用
Efficacy of Oral Nutritional Supplementation Added to Usual Care in Community-dwelling Adults at Risk of Malnutrition and With Low Muscle Strength Following Acute Care
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 304
- 试验地点
- 7
- 主要终点
- Change in body weight
研究概览
简要总结
The study aims to determine the effects of Oral Nutritional Supplement (ONS) added to usual care on body weight compared with usual care alone in community-dwelling adults aged 55 years and older who are at risk of malnutrition and have low muscle strength following acute care.
Participants randomized to receive either ONS twice daily for 180 days plus usual care, or usual care alone. Usual care includes individualized dietary counseling and standardized physical activity advice provided. The study will assess body weight, nutritional status, muscle strength, physical function, dietary intake, and safety outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At risk of malnutrition.
- •At the point of hospital discharge, the admission was for an acute medical illness.
- •Has low maximum handgrip strength.
- •Estimated life expectancy of more than 12 months.
- •Community ambulant.
- •No other chronic disease.
- •Able to communicate and follow instructions.
- •Able to consume food and beverages orally.
- •Willing to refrain from taking non-study oral nutritional supplements over the course of the study.
- •Able and willing to follow study procedures.
排除标准
- •Index hospitalization admission was for a surgical procedure or a stroke/myocardial infarction.
- •Diagnosed with type 1 or type 2 diabetes.
- •Has an active infectious disease.
- •Diagnosed with severe gastrointestinal disorders.
- •With severe or unstable congestive heart failure.
- •With chronic kidney disease stage 2 or higher, end-stage organ failure, or other pre-terminal condition.
- •Has an active malignancy within the past five years or currently receiving treatment for malignancy.
- •Has a severe or unstable musculoskeletal or neuromuscular disorder.
- •Unable to perform a valid handgrip strength assessment.
- •Any condition that makes the participant unsuitable for the study.
- •Currently enrolled in another clinical study.
- •Has an eating disorder, alcoholism or substance abuse.
- •Has dementia, delirium, or a significant neurological or psychiatric disorder.
- •Known allergy or intolerance to any ingredients of the study product.
- •Continuous use of ONS for 14 days prior to the baseline visit.
- •Has used herbal products, dietary supplements, or medications in the past 30 days that could affect body weight, appetite, or body composition.
- •Presence of clinically significant ascites, pleural effusion, edema, or dehydration.
研究组 & 干预措施
Feeding: Intervention
Experimental
干预措施: ONS (Dietary Supplement)
Feeding: Intervention
Experimental
干预措施: Standard of Care (SOC) (Other)
Feeding: None
Other
干预措施: Standard of Care (SOC) (Other)
结局指标
主要结局
Change in body weight
时间窗: Day 0 to Day 180
Measured in kg
次要结局
- Change in body weight(Study Day 30, Study Day 90 and Study Day 180)
- Body mass index (BMI)(Study Day 30, Study Day 90 and Study Day 180)
- Calf circumference(Study Day 30, Study Day 90 and Study Day 180)
- Mid-upper arm circumference (MUAC)(Study Day 30, Study Day 90 and Study Day 180)
- Body composition(Study Day 30, Study Day 90 and Study Day 180)
- Nutrition Risk(Study Day 30, Study Day 90 and Study Day 180)
- Handgrip strength(Study Day 30, Study Day 90 and Study Day 180)
- Short Physical Performance Battery (SPPB) total score(Study Day 30, Study Day 90 and Study Day 180)
- Short Physical Performance Battery (SPPB) component scores(Study Day 30, Study Day 90 and Study Day 180)
- 4-meter gait speed(Study Day 30, Study Day 90 and Study Day 180)
- Chair stand time(Study Day 30, Study Day 90 and Study Day 180)
- Energy, macronutrient and micronutrient intakes(Study Day 30, Study Day 90 and Study Day 180)
- Energy, macronutrient and micronutrient adequacy(Study Day 30, Study Day 90 and Study Day 180)
研究者
研究点 (7)
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