Melatonin Plus Aminoacids for Sarcopenic Elderly (MelAASarc)

Azienda di Servizi alla Persona di Pavia

Status: Completed

Conditions: Sarcopenia

Treatments: Other: Placebo; Dietary Supplement: Essential Aminoacids (eAA); Drug: Melatonin 1mg; Combination Product: Essential Aminoacids + melatonin

Study type: Interventional

Funder types: Other

Identifiers

NCT03784495

1215/11122015

Details and patient eligibility

About

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

Enrollment: 159 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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159 participants in 4 patient groups, including a placebo group

Placebo (P)

Placebo Comparator group

Description:

Placebo.

Treatment:

Other: Placebo

Melatonin (M)

Experimental group

Description:

1 mg/day of melatonin.

Treatment:

Drug: Melatonin 1mg

Essential Aminoacids (eAA)

Experimental group

Description:

4 g/day of essential aminoacids

Treatment:

Dietary Supplement: Essential Aminoacids (eAA)

Essential Aminoacids + Melatonin (eAAM)

Experimental group

Description:

4 g/day of essential aminoacids and 1 mg/day of melatonin

Treatment:

Combination Product: Essential Aminoacids + melatonin