SarcopeniaMelAASarcNCT03784495
Melatonin Plus Aminoacids for Sarcopenic Elderly
A study testing Melatonin 1mg, Essential Aminoacids (eAA) and Essential Aminoacids + melatonin in people with Sarcopenia, run by Azienda di Servizi alla Persona di Pavia at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Melatonin 1mg, Essential Aminoacids (eAA) and Essential Aminoacids + melatonin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 159 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2014to 1 Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- acute illnesses
- severe liver dysfunction
- severe heart dysfunction
- severe kidney dysfunction
- severe dementia
- uncontrolled diabetes
Show all 11Show fewer
- dysthyroidism
- any endocrinopathies
- neoplasia
- patients treated with steroids
- patients entirely unable to walk
Trial locations and contacts
1 site in 1 country.
Italy1 site
Geriatric physical medicine and rehabilitation division at the Istituto Santa Margherita - Azienda di Servizi alla Persona di Pavia
Pavia, 27100
About this study
Official title: 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
- Conditions
- Sarcopenia
- Being tested
- Melatonin 1mg, Essential Aminoacids (eAA), Essential Aminoacids + melatonin, Placebo
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin 1mgDrug
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 + melatoninCombination 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.
PlaceboOther
an isocaloric amount of maltodextrin with the same flavor and appearance as the intervention product
| Study group | Role | What they receive |
|---|---|---|
| Placebo (P) | Placebo comparator | Placebo. Receives: Other: Placebo |
| Melatonin (M) | Experimental | 1 mg/day of melatonin. Receives: Drug: Melatonin 1mg |
| Essential Aminoacids (eAA) | Experimental | 4 g/day of essential aminoacids Receives: Dietary Supplement: Essential Aminoacids (eAA) |
| Essential Aminoacids + Melatonin (eAAM) | Experimental | 4 g/day of essential aminoacids and 1 mg/day of melatonin Receives: Combination Product: Essential Aminoacids + melatonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 0, 30 days
Secondary outcomes (9)
Height
Height measured in meters
Measured: At baseline (0)
Change in Body Weight
Body Weight measured in kilograms
Measured: 0, 30 days
Change in serum proteins
Serum proteins and albumin were measured by automatic biochemical analyzer. They were reported as g/dl
Measured: 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
Measured: 0, 30 days
Change in High-sensitivity C-reactive protein (CRP)
High-sensitivity C-reactive protein (CRP) was expressed in mg/dl.
Measured: 0, 30 days
Change in erythrocyte sedimentation rate (ESR)
Erythrocyte sedimentation rate (ESR) was expressed in mm/hr.
Measured: 0, 30 days
Change in glycaemia
glycemia was expressed in mg/dl
Measured: 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.
Measured: 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
Measured: Measures taken at day 1,2,3 and at day 28,29,30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start1 Jan 2014
- Primary completion31 Dec 2014
- Study completion1 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda di Servizi alla Persona di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariangela Rondanelli, Azienda di Servizi alla Persona di Pavia
- Investigators
- Mariangela Rondanelli, Professor, Study director, IRCCS Mondino Foundation, Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03784495
- Sponsor's protocol ID
- 1215/11122015
- Acronym
- MelAASarc
- Status last verified
- Dec 2018
- First submitted
- 14 Dec 2018
- Last updated
- 24 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be not available for other researchers
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is a Combination of Melatonin and Aminoacids Useful to Sarcopenic Elderly Patients? A Randomized Trial
- ClinicalTrials.gov ID
- NCT03784495
- Acronym / sponsor ID
- MelAASarc / 1215/11122015
- Conditions
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Azienda di Servizi alla Persona di PaviaUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2014 (actual)
- Study completion
- 1 Jun 2015 (actual)
- First posted
- 24 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo (P) | Placebo comparator | Other: PlaceboPlacebo. |
| Melatonin (M) | Experimental | Drug: Melatonin 1mg1 mg/day of melatonin. |
| Essential Aminoacids (eAA) | Experimental | Dietary Supplement: Essential Aminoacids (eAA)4 g/day of essential aminoacids |
| Essential Aminoacids + Melatonin (eAAM) | Experimental | Combination Product: Essential Aminoacids + melatonin4 g/day of essential aminoacids and 1 mg/day of melatonin |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (11 listed)
- acute illnesses
- severe liver dysfunction
- severe heart dysfunction
- severe kidney dysfunction
- severe dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melatonin 1mg1 mg/day 30 minutes before sleep | Drug | Melatonin (M) |
| 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. | Dietary supplement | Essential Aminoacids (eAA) |
| Essential Aminoacids + melatonin4g/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. | Combination product | Essential Aminoacids + Melatonin (eAAM) |
| Placeboan isocaloric amount of maltodextrin with the same flavor and appearance as the intervention product | Other | Placebo (P) |
Primary outcome
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.
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
9 secondary outcomes
Height
Time frame: At baseline (0)
Change in Body Weight
Time frame: 0, 30 days
Change in serum proteins
Time frame: 0, 30 days
Change in blood lipids (total cholesterol and triglycerides)
Time frame: 0, 30 days
Change in High-sensitivity C-reactive protein (CRP)
Time frame: 0, 30 days
Change in erythrocyte sedimentation rate (ESR)
Time frame: 0, 30 days
Change in glycaemia
Time frame: 0, 30 days
Change in Mini Nutritional Assessment (MNA)
Time frame: 0, 30 days
Change in dietary intake
Time frame: Measures taken at day 1,2,3 and at day 28,29,30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2018.
- Individual participant dataSharing planned: No. IPD will be not available for other researchers
Related trials for Sarcopenia
Recruiting
Strength and Dual-Task on Sarcopenia in People With Parkinson's Disease
PARKINSON DISEASE (Disorder), Parkinsonism or Parkinson's Disease Nos
Not yet recruitingObservational study
Malnutrition and Sarcopenia in Adults With Chronic Kidney Disease in Tunisia
Malnutrition, Sarcopenia
RecruitingObservational study
Investigating the Link Between Advanced Glycation End Products (AGEs) and Muscle Wasting in Sarcobesity
Sarcopenia, Obesity
Enrolling by invitation
Physical Activity Interventions for Sleep Improvement and Sedative-Hypnotic Reduction in Middle-Aged and Older Adults: Investigating the Role of Sarcopenia
Insomnia Chronic, Hypnotics and Sedatives
Recruiting
Muscle Deterioration in Hospitalized Cancer Patient
Oncologic Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariangela Rondanelli, Professor study director
IRCCS Mondino Foundation, Pavia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Melatonin 1mg, Essential Aminoacids (eAA) and Essential Aminoacids + melatonin in people with Sarcopenia, run by Azienda di Servizi alla Persona di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Total Fat Mass and Total Free Fat Mass (DXA) (time frame: 0, 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2018.