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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo (P) | Placebo Comparator | Placebo. |
|
| Melatonin (M) | Experimental | 1 mg/day of melatonin. |
|
| Essential Aminoacids (eAA) | Experimental | 4 g/day of essential aminoacids |
|
| Essential Aminoacids + Melatonin (eAAM) | Experimental | 4 g/day of essential aminoacids and 1 mg/day of melatonin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin 1mg | Drug | 1 mg/day 30 minutes before sleep |
| |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Height | Height measured in meters | At baseline (0) |
| Change in Body Weight | Body Weight measured in kilograms | 0, 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mariangela Rondanelli, Professor | IRCCS Mondino Foundation, Pavia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geriatric physical medicine and rehabilitation division at the Istituto Santa Margherita - Azienda di Servizi alla Persona di Pavia | Pavia | 27100 | Italy |
IPD will be not available for other researchers
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Essential Aminoacids (eAA) |
| Dietary Supplement |
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. |
|
| Essential Aminoacids + melatonin | Combination Product | 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. |
|
| Placebo | Other | an isocaloric amount of maltodextrin with the same flavor and appearance as the intervention product |
|
| 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 |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |