Melatonin Plus Aminoacids for Sarcopenic Elderly (MelAASarc)

Is a Combination of Melatonin and Aminoacids Useful to Sarcopenic Elderly Patients? A Randomized Trial

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

Study Overview

• Status: Completed
• Conditions: Sarcopenia
• Intervention / Treatment: Other: Placebo; Drug: Melatonin 1mg; Dietary supplement: Essential Aminoacids (eAA); Combination product: Essential Aminoacids + melatonin

• Study Type: Interventional
• Enrollment (Actual): 159
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Pavia, Italy, 27100
    • Geriatric physical medicine and rehabilitation division at the Istituto Santa Margherita - Azienda di Servizi alla Persona di Pavia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 61 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo (P); Placebo.	Other: Placebo; an isocaloric amount of maltodextrin with the same flavor and appearance as the intervention product
Experimental: Melatonin (M); 1 mg/day of melatonin.	Drug: Melatonin 1mg; 1 mg/day 30 minutes before sleep
Experimental: Essential Aminoacids (eAA); 4 g/day of essential aminoacids	Dietary supplement: 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.
Experimental: Essential Aminoacids + Melatonin (eAAM); 4 g/day of essential aminoacids and 1 mg/day of melatonin	Combination product: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Height	Height measured in meters	At baseline (0)
Change in Body Weight	Body Weight measured in kilograms	0, 30 days
Change in serum proteins	Serum proteins and albumin were measured by automatic biochemical analyzer. They were reported as g/dl	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	0, 30 days
Change in High-sensitivity C-reactive protein (CRP)	High-sensitivity C-reactive protein (CRP) was expressed in mg/dl.	0, 30 days
Change in erythrocyte sedimentation rate (ESR)	Erythrocyte sedimentation rate (ESR) was expressed in mm/hr.	0, 30 days
Change in glycaemia	glycemia was expressed in mg/dl	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.	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	Measures taken at day 1,2,3 and at day 28,29,30

Collaborators and Investigators

• Sponsor: Azienda di Servizi alla Persona di Pavia
• Investigators: Study Director: Mariangela Rondanelli, Professor, IRCCS Mondino Foundation, Pavia

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): December 31, 2014
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: December 14, 2018
• First Submitted That Met QC Criteria: December 21, 2018
• First Posted (Actual): December 24, 2018

Study Record Updates

• Last Update Posted (Actual): December 24, 2018
• Last Update Submitted That Met QC Criteria: December 21, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Protective Agents; Antioxidants; Melatonin
• Other Study ID Numbers: 1215/11122015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: IPD will be not available for other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No