Melatonin Plus Aminoacids for Sarcopenic Elderly

Sarcopenia Clinical Trial

— MelAASarc  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03784495
• Other study ID #: 1215/11122015
• Status: Completed
• Phase: N/A
• Start date: January 1, 2014
• Est. completion date: June 1, 2015

Study information

• Verified date: December 2018
• Source: Azienda di Servizi alla Persona di Pavia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: June 1, 2015
• Est. primary completion date: December 31, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Drug:
• Melatonin 1mg
1 mg/day 30 minutes before sleep

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.

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.

Other:
• Placebo
an isocaloric amount of maltodextrin with the same flavor and appearance as the intervention product

Locations

Country	Name	City	State
Italy	Geriatric physical medicine and rehabilitation division at the Istituto Santa Margherita - Azienda di Servizi alla Persona di Pavia	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
Azienda di Servizi alla Persona di Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Height	Height measured in meters	At baseline (0)
Secondary	Change in Body Weight	Body Weight measured in kilograms	0, 30 days
Secondary	Change in serum proteins	Serum proteins and albumin were measured by automatic biochemical analyzer. They were reported as g/dl	0, 30 days
Secondary	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
Secondary	Change in High-sensitivity C-reactive protein (CRP)	High-sensitivity C-reactive protein (CRP) was expressed in mg/dl.	0, 30 days
Secondary	Change in erythrocyte sedimentation rate (ESR)	Erythrocyte sedimentation rate (ESR) was expressed in mm/hr.	0, 30 days
Secondary	Change in glycaemia	glycemia was expressed in mg/dl	0, 30 days
Secondary	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
Secondary	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