Is a Combination of Melatonin and Aminoacids Useful to Sarcopenic Elderly Patients? A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 159
- 试验地点
- 1
- 主要终点
- Change in Handgrip Strenght
研究概览
简要总结
To evaluate the effectiveness of melatonin and essential aminoacid supplementation on body composition, protein metabolism, strength and inflammation. The investigators performed a Randomized controlled parallel groups preliminary trial in 159 elderly sarcopenic people (42/117 men/women) assigned to 4 groups: isocaloric placebo (P, n=44), melatonin (M, 1 mg/daily, n=42,), essential aminoacids (eAA 4 g/daily, n=40) or eAA plus melatonin (eAAM, 4 g eAA and 1 mg melatonin/daily, n= 30). The period of intervention was 4 weeks. Data from body composition (DXA), strength (handgrip test) and biochemical parameters for the assessment of protein metabolism (albumin) and inflammation (PRC) were collected at baseline and after the 4-week intervention
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
- 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 > or equal 65 years
- •Sarcopenic patients, following the Rosetta Study criteria: Skeletal Muscle Index [SMI] was <7.23 kg/m2 in men and <5.45 kg/m2 in women) and loss of strength, evaluated by dynamometer and defined as <30 kg for men and <20 kg for women, using the average value of the two handgrip measurements of the dominant hand.
排除标准
- •acute illnesses
- •severe liver dysfunction
- •severe heart dysfunction
- •severe kidney dysfunction
- •severe dementia
- •uncontrolled diabetes
- •dysthyroidism
- •any endocrinopathies
- •neoplasia
- •patients treated with steroids
- •patients entirely unable to walk
研究组 & 干预措施
Placebo (P)
Placebo.
干预措施: Placebo (Other)
Melatonin (M)
1 mg/day of melatonin.
干预措施: Melatonin 1mg (Drug)
Essential Aminoacids (eAA)
4 g/day of essential aminoacids
干预措施: Essential Aminoacids (eAA) (Dietary Supplement)
Essential Aminoacids + Melatonin (eAAM)
4 g/day of essential aminoacids and 1 mg/day of melatonin
干预措施: Essential Aminoacids + melatonin (Combination Product)
结局指标
主要结局
Change in Handgrip Strenght
时间窗: 0, 30 days
Handgrip strength assessed using a Jamar dynamometer adhering to the standardized protocol recommended by the American Society of Hand Therapists. A weak handgrip was defined as \<30 kg for men and \<20 kg for women, based on the average value of the two handgrip measurements of the dominant hand
Change in Total Fat Mass and Total Free Fat Mass (DXA)
时间窗: 0, 30 days
Body composition by dual-energy X-ray absorptiometry (DXA). Body composition was measured by DXA, using a Lunar Prodigy DXA (GE Medical Systems, Waukesha, WI). Free Fat mass and Fat mass of specific body regions were measured in kilograms.
次要结局
- Height(At baseline (0))
- Change in erythrocyte sedimentation rate (ESR)(0, 30 days)
- Change in dietary intake(Measures taken at day 1,2,3 and at day 28,29,30)
- Change in Body Weight(0, 30 days)
- Change in blood lipids (total cholesterol and triglycerides)(0, 30 days)
- Change in High-sensitivity C-reactive protein (CRP)(0, 30 days)
- Change in glycaemia(0, 30 days)
- Change in serum proteins(0, 30 days)
- Change in Mini Nutritional Assessment (MNA)(0, 30 days)
研究者
Mariangela Rondanelli
MD, Associate Professor
Azienda di Servizi alla Persona di Pavia