An interventional study of Melatonin 1mg and Essential Aminoacids (eAA) in Sarcopenia, sponsored by Azienda di Servizi alla Persona di Pavia. Completed at 1 site in Italy. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2018-12-24.
Sponsored by Azienda di Servizi alla Persona di Pavia · Not applicable, Interventional, and Treatment
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
1,208 studies on the registry are indexed under Sarcopenia; 402 are open to participants now.
This study's enrollment of 159 is above the median of 60 across 775 interventional studies indexed under Sarcopenia.
Browse Sarcopenia studies →Azienda di Servizi alla Persona di Pavia is the lead sponsor of 27 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Placebo.
Other: Placebo
1 mg/day of melatonin.
Drug: Melatonin 1mg
4 g/day of essential aminoacids
Dietary Supplement: Essential Aminoacids (eAA)
4 g/day of essential aminoacids and 1 mg/day of melatonin
Combination Product: Essential Aminoacids + melatonin
1 mg/day 30 minutes before sleep
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.
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.
an isocaloric amount of maltodextrin with the same flavor and appearance as the intervention product
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.
Time frame: 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
Time frame: 0, 30 days
Height
Height measured in meters
Time frame: At baseline (0)
Change in Body Weight
Body Weight measured in kilograms
Time frame: 0, 30 days
Change in serum proteins
Serum proteins and albumin were measured by automatic biochemical analyzer. They were reported as g/dl
Time frame: 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
Time frame: 0, 30 days
Change in High-sensitivity C-reactive protein (CRP)
High-sensitivity C-reactive protein (CRP) was expressed in mg/dl.
Time frame: 0, 30 days
Change in erythrocyte sedimentation rate (ESR)
Erythrocyte sedimentation rate (ESR) was expressed in mm/hr.
Time frame: 0, 30 days
Change in glycaemia
glycemia was expressed in mg/dl
Time frame: 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.
Time frame: 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
Time frame: Measures taken at day 1,2,3 and at day 28,29,30
Plan to share: No — IPD will be not available for other researchers
No publications or documents are linked to this record.
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Azienda di Servizi alla Persona di Pavia