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Completed

NCT Number: NCT03784495

Melatonin Plus Aminoacids for Sarcopenic Elderly

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

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Key information

Conditions

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

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Pavia, 27100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Melatonin 1mg

Drug

1 mg/day 30 minutes before sleep

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 + 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.

Placebo

Other

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

Primary outcomes

  1. Change in Total Fat Mass and Total Free Fat Mass (DXA)

    Time frame: 0, 30 days

    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.

  2. Change in Handgrip Strenght

    Time frame: 0, 30 days

    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

Secondary outcomes

  1. Height

    Time frame: At baseline (0)

    Height measured in meters

  2. Change in Body Weight

    Time frame: 0, 30 days

    Body Weight measured in kilograms

  3. Change in serum proteins

    Time frame: 0, 30 days

    Serum proteins and albumin were measured by automatic biochemical analyzer. They were reported as g/dl

  4. Change in blood lipids (total cholesterol and triglycerides)

    Time frame: 0, 30 days

    Blood lipids (total cholesterol and triglycerides)were measured by automatic biochemical analyzer. They were reported as mg/dl

  5. Change in High-sensitivity C-reactive protein (CRP)

    Time frame: 0, 30 days

    High-sensitivity C-reactive protein (CRP) was expressed in mg/dl.

  6. Change in erythrocyte sedimentation rate (ESR)

    Time frame: 0, 30 days

    Erythrocyte sedimentation rate (ESR) was expressed in mm/hr.

  7. Change in glycaemia

    Time frame: 0, 30 days

    glycemia was expressed in mg/dl

  8. Change in Mini Nutritional Assessment (MNA)

    Time frame: 0, 30 days

    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.

  9. Change in dietary intake

    Time frame: Measures taken at day 1,2,3 and at day 28,29,30

    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

Sponsors and collaborators

Lead sponsor

Azienda di Servizi alla Persona di Pavia

Other

Registry information

Official study title

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

Acronym: MelAASarc

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Dec 24, 2018
Registry last updated
Dec 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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