Melatonin Plus Aminoacids for Sarcopenic Elderly

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda di Servizi alla Persona di Pavia
• Treatments: Melatonin

Criteria

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