Prospective, Open-Label, Multicenter Study to Characterise the Effects of Co-administration of MediDrink Platinum+ Formula Containing Novel Protein Blend SPR-01 and Fava Bean Protein Hydrolysate on Fitness in an Aged Population
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 试验地点
- 4
- 主要终点
- General well-being via Barthel Index
研究概览
简要总结
Examining the effects of MediDrink Platinum+ containing novel protein blend SRP-01 alone or when combined with PeptiStrong on clinical responses in elderly adults with sarcopenia
详细描述
The primary aim of this multicentre randomised active control group study , is to characterise the effect of MediDrink Platinum+ containing a novel protein blend SPR-01, alone and in combination with PeptiStrong on general fitness measured via the Barthel index in malnourished sarcopenic, adults, aged 60 and above. The trial will incorporate a "Y" design whereby all 75 participants begin on the base formula (MediDrink Platinum) for 2 weeks before being randomised into the SPR-01 alone (n=37, dose calculated per individual but at least 1200 kcal/day) or SP1-01 and PeptStrong (n=38, dose calculated per individual but at least 1200 kcal per day and 2.4g/day, respectively) supplementation arms for 10 weeks.
Other clinical endpoints measured as secondary endpoints will include hand grip strength, physical functioning via time up&go test and changes in fat-free body mass.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •60 years or older
- •BMI ≤ 25 kg/m²
- •Malnourished (mini nutritional assessment MNA <11
- •Sarcopenic: SARC-F score ≥ 4
- •Capable or oral feeding either alone or assisted
- •Ambulatory (WHO PS/ECOG 0-3)
- •Ability to complete questionnaires and self assess health status
- •Ability to provide consent
排除标准
- •Patient cannot eat orally
- •Acute Infection
- •Proven Intestinal obstruction
- •Co-morbidities requiring a special diet (diabetes, kidney disease etc.)
- •Liver dysfunction
- •Acute or chronic renal failure
- •Uncontrollable nausea or vomiting
- •Use of megestrol acetate or metabolic steroids
- •Dietary supplement use in the last 3 months
- •Known intolerance or allergy to the investigational products
- •Participation in any clinical trial within the last 3 months
结局指标
主要结局
General well-being via Barthel Index
时间窗: Whole group Week 0 to Week 2. Investigational arms Week 2 to Week 12
Time to 5 point change in Barthel Index compared from baseline (visit 0) to week 2 in the whole patient population versus week 2 to week 12 in the two investigational groups; MediDrink Platinum+ and MediDrink Platinum+ with PeptiStrong. The Barthel scale measures the ability to perform basic activities of daily living using 10 variables describing mobility. A higher value is associated with a higher likelihood of independence
General well-being via Barthel Index
时间窗: Whole group Week 0 to Week 2. Investigational arms Week 2 to Week 12
Time to 5 point change in Barthel Index compared from baseline (visit 0) to week 2 in the whole patient population versus week 2 to week 12 in the two investigational groups; MediDrink Platinum+ and MediDrink Platinum+ with PeptiStrong. The Barthel scale measures the ability to perform basic activities of daily living using 10 variables describing mobility. A higher value is associated with a higher likelihood of independence
次要结局
- Hand Grip Strength via Dynamometer(Whole group Week 0 to Week 2. Investigational arms Week 2 to Week 12)
- Fat-free body mass via bioelectrical impedance analysis(Whole group Week 0 to Week 2. Investigational arms Week 2 to Week 12)
- Hand Grip Strength via Dynamometer(Whole group Week 0 to Week 2. Investigational arms Week 2 to Week 12)
- Fat-free body mass via bioelectrical impedance analysis(Whole group Week 0 to Week 2. Investigational arms Week 2 to Week 12)
- Functional performance via time up & go test(Whole group Week 0 to Week 2. Investigational arms Week 2 to Week 12)