Nutritional Supplement to Improve Physical Performance in Geriatric Day Hospital Participants: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Feasibility: adherence to intervention
研究概览
简要总结
Geriatric Day Hospitals (GDH) of the McGill University Health Centre and l'Institut de Gériatrie de Montreal offer comprehensive rehabilitation programs including physiotherapy and medical care, but no dietetic counselling for the attending frail population at high risk of malnutrition. This study aims to implement a multi-nutrient supplement to further improve nutritional status, physical function and capacity. A whey protein, leucine, vitamin D and omega-3 fatty acid supplement ingested during 16 weeks will be tested versus an isocaloric placebo on measures of physical performance and muscle mass and strength, in GDH participants. The specific objective of this pilot-study is to test feasibility and adherence; pilot data could lead to a larger trial.
详细描述
RATIONALE Given the high prevalence of malnutrition of the GDH participants and its impact on poor physical performance, providing a nutritional supplement to increase protein, leucine, vitamin D and omega-3 FA intake should complement and optimize the rehabilitation interventions in improving muscle mass, strength and physical performance.
OBJECTIVES
Implementing the proposed nutritional supplement in the routine care of GDH participants will:
- test the feasibility, acceptance and adherence to the supplement and its safety
- provide pilot data to test the superiority of the supplement versus an isocaloric placebo on measures of muscle mass, strength, and physical performance.
STUDY DESIGN. This is a randomized, placebo-controlled, double-blinded trial of two parallel arms, conducted on two sites. Eligible participants will be randomly assigned to one of two groups: experimental (EXP) or control (CTR) in a 1:1 ratio. Randomization will be achieved by computer-generated permuted block of four.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Isocaloric placebos of same taste and texture as the experimental supplements
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •participants of Geriatric Day Hospital programs
- •able to understand study requirements (Mini Mental State Exam, MMSE >22/30)
- •able to read and speak English or French
排除标准
- •BMI >35 kg/m2
- •glomerular filtration rate <30 mL/min/SA),
- •liver or heart failure,
- •stroke in the last 6 months (unless totally recovered),
- •Parkinson's disease or severe neurologic conditions,
- •active malignancies,
- •acute inflammation (CRP >10 mg/L),
- •known diagnostic of hyperparathyroidism,
- •recent acute weight loss (>10% in 3 months, unless stabilized),
- •allergy to milk and/or fish,
- •long-term use of corticosteroids or anti-neoplastic medication
研究组 & 干预措施
EXP
EXP group will ingest a supplement consisting of 1) flavored whey protein isolate with added pure leucine (3 g) diluted in water, twice daily, before breakfast and before bedtime; doses are adjusted per body weight as follows: 20 g, 25 g or 30 g per category of <65 kg, 65-75 kg and >75 kg of body weight respectively. 2) fish oil containing vitamin D, provided as 7.5 mL liquid oil providing 1500 IU vitamin D3 + 1125 mg EPA + 750 mg DHA, to be ingested once daily.
干预措施: Multi-nutrient supplement (Dietary Supplement)
CTR
Control will ingest an isocaloric placebo consisting of 1) 30 g maltodextrin, twice daily, following the same schedule, and 2) 7.5 mL corn oil, once daily.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Feasibility: adherence to intervention
时间窗: Over 16 weeks
Adherence to supplements (measured in %, compared to expected rates)
Feasibility: completion
时间窗: Over 16 weeks
Completion of study outcome assessments (measured in %, compared to expected rates)
Feasibility: recruitment rate
时间窗: Recruitment over 2 years
Recruitment rate (measured in %, compared to expected rates)
次要结局
- Leg strength(Weeks 0, 8 and 16)
- Chair stand test(Weeks 0, 8 and 16)
- 6-minute walking test(Weeks 0, 8 and 16)
- Timed-up-and-go test(Weeks 0, 8 and 16)
- Handgrip strength(Weeks 0, 8 and 16)
- Appendicular lean mass(Weeks 0 and 16)
研究者
Stéphanie Chevalier
Associate Professor
McGill University