Melatonin Plus Aminoacids for Sarcopenic Elderly

NCT03784495 | Completed

• 1 other identifier: 1215/11122015
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (9)

• Height

  At baseline (0)

• Change in Body Weight

  0, 30 days

• Change in serum proteins

  0, 30 days

• Change in blood lipids (total cholesterol and triglycerides)

  0, 30 days

• Change in High-sensitivity C-reactive protein (CRP)

  0, 30 days

Study Arms (4)

Placebo (P)

PLACEBO COMPARATOR

Placebo.

Other: Placebo

Melatonin (M)

EXPERIMENTAL

1 mg/day of melatonin.

Drug: Melatonin 1mg

Essential Aminoacids (eAA)

EXPERIMENTAL

4 g/day of essential aminoacids

Dietary Supplement: Essential Aminoacids (eAA)

Essential Aminoacids + Melatonin (eAAM)

EXPERIMENTAL

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

Combination Product: Essential Aminoacids + melatonin

Interventions

Melatonin 1mg DRUG

1 mg/day 30 minutes before sleep

Melatonin (M)

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 (eAA)

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.

Essential Aminoacids + Melatonin (eAAM)

Placebo OTHER

an isocaloric amount of maltodextrin with the same flavor and appearance as the intervention product

Placebo (P)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda di Servizi alla Persona di Pavia: lead

Study Sites (1)

Geriatric physical medicine and rehabilitation division at the Istituto Santa Margherita - Azienda di Servizi alla Persona di Pavia

Pavia, 27100, Italy

Location

MeSH Terms

Conditions

Sarcopenia

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Mariangela Rondanelli, Professor

  IRCCS Mondino Foundation, Pavia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Associate Professor

Study Record Dates

• First Submitted: December 14, 2018
• First Posted: December 24, 2018
• Study Start: January 1, 2014
• Primary Completion: December 31, 2014
• Study Completion: June 1, 2015
• Last Updated: December 24, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)