Melatonin Plus Aminoacids for Sarcopenic Elderly
- Conditions
- Sarcopenia
- Interventions
- Dietary Supplement: Essential Aminoacids (eAA)Combination Product: Essential Aminoacids + melatoninOther: Placebo
- Registration Number
- NCT03784495
- Lead Sponsor
- Azienda di Servizi alla Persona di Pavia
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 159
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Essential Aminoacids (eAA) Essential Aminoacids (eAA) 4 g/day of essential aminoacids Essential Aminoacids + Melatonin (eAAM) Essential Aminoacids + melatonin 4 g/day of essential aminoacids and 1 mg/day of melatonin Melatonin (M) Melatonin 1mg 1 mg/day of melatonin. Placebo (P) Placebo Placebo.
- Primary Outcome Measures
Name Time Method Change in Handgrip Strenght 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) 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.
- Secondary Outcome Measures
Name Time Method Height At baseline (0) Height measured in meters
Change in erythrocyte sedimentation rate (ESR) 0, 30 days Erythrocyte sedimentation rate (ESR) was expressed in mm/hr.
Change in dietary intake Measures taken at day 1,2,3 and at day 28,29,30 A trained dietitian used a calibrated dietetic spring scale to weigh all foods served and returned for 3 consecutive days at the beginning and end of the study
Change in Body Weight 0, 30 days Body Weight measured in kilograms
Change in blood lipids (total cholesterol and triglycerides) 0, 30 days Blood lipids (total cholesterol and triglycerides)were measured by automatic biochemical analyzer. They were reported as mg/dl
Change in High-sensitivity C-reactive protein (CRP) 0, 30 days High-sensitivity C-reactive protein (CRP) was expressed in mg/dl.
Change in glycaemia 0, 30 days glycemia was expressed in mg/dl
Change in serum proteins 0, 30 days Serum proteins and albumin were measured by automatic biochemical analyzer. They were reported as g/dl
Change in Mini Nutritional Assessment (MNA) 0, 30 days A mini nutritional assessment (MNA) was performed for all participants. The MNA uses 18 questions regarding simple measurements and a brief questionnaire involving an anthropometric assessment (weight, height and weight loss), a general assessment (lifestyle, medication and mobility), and a dietary assessment (number of meals, food and fluid intake, self-assessment of eating autonomy and self-perception of health and nutrition). Every answer give up to a maximum of 3 points. The sum of all points gives the total MNA. A maximum of 30 points can be achieved. A score of ≥ 24 points describes a well-nourished status. A score of 17 to 23.5 points indicates a risk of malnutrition, while less than 17 points indicates malnutrition.
Trial Locations
- Locations (1)
Geriatric physical medicine and rehabilitation division at the Istituto Santa Margherita - Azienda di Servizi alla Persona di Pavia
🇮🇹Pavia, Italy