Melatonin Plus Aminoacids for Sarcopenic Elderly

Study Overview
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Brief Summary
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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

Official Title
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Is a Combination of Melatonin and Aminoacids Useful to Sarcopenic Elderly Patients? A Randomized Trial

Conditions
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Sarcopenia

Intervention / Treatment
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* Drug: Melatonin 1mg
* Dietary Supplement: Essential Aminoacids (eAA)
* Combination Product: Essential Aminoacids + melatonin
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo (P)<br>Placebo. | Other: Placebo<br>* an isocaloric amount of maltodextrin with the same flavor and appearance as the intervention product<br>|
| Experimental: Melatonin (M)<br>1 mg/day of melatonin. | Drug: Melatonin 1mg<br>* 1 mg/day 30 minutes before sleep<br>|
| Experimental: Essential Aminoacids (eAA)<br>4 g/day of essential aminoacids | Dietary Supplement: Essential Aminoacids (eAA)<br>* 4g/day of Essential Aminoacids during breakfast. Packets of powdered amino acid supplements (42.0% leucine, 14.0% lysine, 10.5% valine, 10.5% isoleucine, 10.5% threonine, 7.0% phenylalanine, and 5.5% other) were provided for the participants to be taken with water or milk, and they were instructed to take the 4-gram supplement once a day every day for 4 weeks.<br>|
| Experimental: Essential Aminoacids + Melatonin (eAAM)<br>4 g/day of essential aminoacids and 1 mg/day of melatonin | Combination Product: Essential Aminoacids + melatonin<br>* 4g/day of Essential Aminoacids during breakfast + 1 mg/day of Melatonin 30 minutes before sleep. Packets of powdered amino acid supplements (42.0% leucine, 14.0% lysine, 10.5% valine, 10.5% isoleucine, 10.5% threonine, 7.0% phenylalanine, and 5.5% other) were provided for the participants to be taken with water or milk, and they were instructed to take the 4-gram supplement once a day every day for 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Total Fat Mass and Total Free Fat Mass (DXA) | 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. | 0, 30 days | 
| Change in Handgrip Strenght | 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 | 0, 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Height | Height measured in meters | At baseline (0) | 
| Change in Body Weight | Body Weight measured in kilograms | 0, 30 days | 
| Change in serum proteins | Serum proteins and albumin were measured by automatic biochemical analyzer. They were reported as g/dl | 0, 30 days | 
| Change in blood lipids (total cholesterol and triglycerides) | Blood lipids (total cholesterol and triglycerides)were measured by automatic biochemical analyzer. They were reported as mg/dl | 0, 30 days | 
| Change in High-sensitivity C-reactive protein (CRP) | High-sensitivity C-reactive protein (CRP) was expressed in mg/dl. | 0, 30 days | 
| Change in erythrocyte sedimentation rate (ESR) | Erythrocyte sedimentation rate (ESR) was expressed in mm/hr. | 0, 30 days | 
| Change in glycaemia | glycemia was expressed in mg/dl | 0, 30 days | 
| Change in Mini Nutritional Assessment (MNA) | 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. | 0, 30 days | 
| Change in dietary intake | 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 | Measures taken at day 1,2,3 and at day 28,29,30 |