Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
159 participants
INTERVENTIONAL
2014-01-01
2015-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo (P)
Placebo.
Placebo
an isocaloric amount of maltodextrin with the same flavor and appearance as the intervention product
Melatonin (M)
1 mg/day of melatonin.
Melatonin 1mg
1 mg/day 30 minutes before sleep
Essential Aminoacids (eAA)
4 g/day of essential aminoacids
Essential Aminoacids (eAA)
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 (eAAM)
4 g/day of essential aminoacids and 1 mg/day of melatonin
Essential Aminoacids + melatonin
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.
Interventions
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Melatonin 1mg
1 mg/day 30 minutes before sleep
Essential Aminoacids (eAA)
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
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
an isocaloric amount of maltodextrin with the same flavor and appearance as the intervention product
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
65 Years
ALL
No
Sponsors
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Azienda di Servizi alla Persona di Pavia
OTHER
Responsible Party
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Mariangela Rondanelli
MD, Associate Professor
Principal Investigators
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Mariangela Rondanelli, Professor
Role: STUDY_DIRECTOR
IRCCS Mondino Foundation, Pavia
Locations
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Geriatric physical medicine and rehabilitation division at the Istituto Santa Margherita - Azienda di Servizi alla Persona di Pavia
Pavia, , Italy
Countries
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Other Identifiers
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1215/11122015
Identifier Type: -
Identifier Source: org_study_id