Public HealthSmmSNCT04584944
Appendicular Skeletal Muscle Mass Study
An observational study of Public Health and Sarcopenia, run by Henry Dunant Hospital Center at 1 site in Greece.
Trial summary
There is a lot of discussion concerning the normal cut-off points of skeletal mass among different populations worldwide. Genetic and environmental differences most probably lead to different measurements. Read more about this study
- Who is it for?
- Ages 20 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Public Health, Sarcopenia
- What is being tested?
- Dual energy X-ray absorptiometry
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jun 2020to 30 Jun 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 20 to 44 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study population will be healthy adults that meet the inclusion criteria and can have access to the study site. The recruitment will be performed using the snowball sampling technique (for instance, through printed material, the marketing department of the hospital, social media (Facebook/Instagram/Twitter), advertising banners, etc.). We will also invite participants from nearby academic institutions, organizations, municipalities, etc. It is foreseen to include 500 participants in the study.
Who may be able to join
- Healthy Greek young adults (20 - 44 years old), with Caucasian characteristics.
- Able to read and write in Greek language.
Who cannot join
- Chronic diseases, such as, heart diseases, type II diabetes mellitus and autoimmune diseases.
- Hyperthyroidism or hypothyroidism (persons with normal thyroid function for six months are included).
- Malignancies.
- Seizures of epilepsy, neurodegenerative diseases.
- Asthma and/or chronic respiratory pulmonary disease-Chronic Obstructive Pulmonary Disease.
- Metal prefixes.
Show all 18Show fewer
- Pacemaker.
- Systematic medication intake (such as hypolipemic drugs, antihypertensive drugs, antidepressants, glucocorticoids and any other hormonal treatment).
- Protein formulations and anabolic intake.
- Hormone intake (testosterone, estrogen, contraceptive, growth hormone, dehydroepiandrosterone.
- Professional athletes and people with intense physical activity, intensive exercise with weights, long-distance runners (Marathons).
- Substance use or abuse (cocaine, heroin, amphetamines).
- Pregnancy.
- History of hospitalization in Intensive Care Unit
- History of serious injury
- Considerable body weight alterations during the previous year (increase or decrease)
- History of Bariatric surgery
- Any dietary restriction due to disease (sprue), choice (vegan), or eating disorder (anorexia nervosa).
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Henry Dunant Hospital Center
Athens
Anastasia Koutsouri, 00306944413656, nkalamak@yahoo.gr
George Soulis, 00306947123967, geosoulis@yahoo.com
About this study
Official title: Appendicular Skeletal Muscle Mass Adult Reference Measurements in Greek Population
There is a lot of discussion concerning the normal cut-off points of skeletal mass among different populations worldwide. Genetic and environmental differences most probably lead to different measurements. Defining muscle mass in healthy young adults in Greece will provide information that can be used to determine normal ranges of muscle mass of both sexes and consequently define sarcopenia.
The aim of the study is to define appendicular skeletal muscle mass reference measurements in healthy young adults in Greece. These values can be used to determine sarcopenia cut-offs according to recommendations.
Read the detailed description
Introduction
The reduction of muscle mass in humans is obvious after the age of fifty, with a reduction rate of 3-8% every ten years. The rate of loss accelerates with chronic diseases, sedentary lifestyle, low physical activity, nutritional, environmental and socioeconomic factors .
Sarcopenia has been officially recognized as a disease according to World Health Organization. European Working Group on Sarcopenia in Older People 2 has revised the definition and diagnostic criteria of sarcopenia aiming to encourage more research in the field. In Greece, there are no reference values for muscle strength and muscle mass. Defining these values will permit the investigators to provide a tool that will help to establish country - specific measurements of sarcopenia in Greek population.
Study population-Methods
The study site will be the Outpatient Geriatric Assessment Unit and the Radiology Department of Henry Dunant Hospital Centre, in Athens-Greece.
The study population will be healthy adults that meet the inclusion criteria. The recruitment will be performed using the snowball sampling technique (for instance, through printed material, the marketing department of the hospital, social media, advertising banners, etc.). Stratified random sampling technique will be used to achieve a representative sample size.
Evaluation of the appendicular muscle mass of the limbs will be performed by Dual-Energy X-ray Absorptiometry, using a QDR-4500 A fan Beam densitometer (Hologic, Inc., Bedford, MA). Hologic Discovery W configured with software version 12.1 (Hologic, Bedford, MA).
Body composition analysis will be evaluated with TANITA Body Composition Analyzer device,model BC-418MA. Analysis concerns calculation of body consistency (body fat mass, lean mass water and predicted muscle mass) using Bioelectric Impedance Analysis. Bioelectric Impedance Analysis measures the body composition using a constant power source (high frequency current 50kHz, 90 μA).
Muscle mass will also be measured by ultrasound -U/S. U/S determines the thickness and transverse incisions of a superficial muscle group. It can measure basic parameters such as muscle volume and spectrum length through the B-Mode imaging with Linear 7-12MHz frequency heads that can reliably determine the thickness and transverse incisions of the superficial muscular Groups.
Statistical analysis
It will be performed using the Statistical Package for the Social Sciences -SPSS Version 26.0 (IBM), and R Version 3.6.2.
Descriptive statistics will be presented in percentage proportions, mean values and Standard Deviations (SD) of the variables. In addition, Z-score will be calculated (e.g. Dual-energy X-ray absorptiometry , Bone Mineral density, Dual-energy X-ray absorptiometry % fat, etc.) and T-score ± 2 standard deviations.
Chi-square - χ2 tests or non-parametric tests will be produced to compare qualitative variables. T-test, Analysis of Variance- ANOVA and non-parametric tests will be used in the statistical analysis of quantitative variables within the categories of qualitative variables.
Approval
The protocol has been approved by the Scientific Committee of the Henry Dunant Hospital Centre, in Athens -Greece, and is in accordance with the Code of Ethics of the World Organization for Medical Sciences (CIOMS) as formulated in the Helsinki Declaration on Biological Research.
Informed consent
All participants will be informed in written for the purpose of the research, and the way their personal data are processed (name, address, telephone, e-mail), under the provisions of 2016/679 according to the General Data Protection Regulation (GDPR).
The consent form will describe the legal and transparent way of processing their data, stating the specific purpose for data collection, as well as information about storage of their data. It will also contain a written description of the rights of the participants concerning their data and their ability to revoke consent for the processing of their data. The processing, transfer and storage of data, will also be described, as well as who will have access to their data, and how long the data will be stored for.
Finally, all participants will sign the written informed consent and confidentiality form.
- Conditions
- Public Health, Sarcopenia
- Being tested
- Dual energy X-ray absorptiometry
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual energy X-ray absorptiometryRadiation
Also called Bioelectrical Impedance Analysis, Ultrasound
Evaluation of the appendicular muscle mass of the limbs will be performed by Dual-Energy X-ray Absorptiometry, using a QDR 4500. Body composition analysis will also be evaluated with TANITA Body Composition Analyzer device,model BC-418MA. Bioelectrical Impedance Analysis measures the body composition using a constant power source (high frequency current 50kHz, 90 μA).
Muscle mass is also going to be measured by using ultrasound -U/S. It measures basic parameters such as muscle volume and spectrum length through the B-Mode imaging with Linear 7-12MHz frequency heads that can reliably determine the thickness and transverse incisions of the superficial muscular Groups.
| Study group | Role | What they receive |
|---|---|---|
| Healthy adult men | Healthy young men, 20- 44 years old Receives: Radiation: Dual energy X-ray absorptiometry | |
| Healthy adult women | Healthy young women, 20- 44 years old Receives: Radiation: Dual energy X-ray absorptiometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appendicular skeletal muscle mass reference measurements of healthy young adults in Greece
Measurements of appendicular skeletal muscle mass of healthy young adults in Greece that will be used to define sarcopenia in older adults and as normative values.
Measured: 01/06/2022
Define reference measurements for muscle strength.
Reference measurements for hand grip
Measured: 01/06/2022
Define reference measurements for muscle performance
Reference measurements for walking speed
Measured: 01/06/2022
Secondary outcomes (5)
Correlations between the different tools used to measure muscle mass
Investigate accuracy and potential differences between the different techniques used to measure muscle mass.
Measured: 01/06/2022
Correlation of muscle mass with demographic characteristics
Investigate correlation of muscle mass with demographic characteristics of the studied population
Measured: 01/06/2022
Correlation of bone mass with demographic characteristics
Investigate correlation of bone mass with demographic characteristics of the studied population.
Measured: 01/06/2022
Correlation of fat mass with demographic characteristics
Investigate correlation of fat mass with demographic characteristics of the studied population.
Measured: 01/06/2022
Correlation of adherence to Mediterranean diet with muscle mass
Investigate potential correlation of adherence to Mediterranean diet with muscle mass.
Measured: 01/06/2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start1 Jun 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Public HealthStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Henry Dunant Hospital Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anastasia Koutsouri, Study chair, Head of the Outpatient Geriatric Assessment Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04584944
- Sponsor's protocol ID
- 3080234A
- Acronym
- SmmS
- Status last verified
- Oct 2020
- First submitted
- 3 Sep 2020
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jul 1;48(4):601. doi: 10.1093/ageing/afz046. No abstract available.
PubMed 31081853Buckinx F, Landi F, Cesari M, Fielding RA, Visser M, Engelke K, Maggi S, Dennison E, Al-Daghri NM, Allepaerts S, Bauer J, Bautmans I, Brandi ML, Bruyere O, Cederholm T, Cerreta F, Cherubini A, Cooper C, Cruz-Jentoft A, McCloskey E, Dawson-Hughes B, Kaufman JM, Laslop A, Petermans J, Reginster JY, Rizzoli R, Robinson S, Rolland Y, Rueda R, Vellas B, Kanis JA. Pitfalls in the measurement of muscle mass: a need for a reference standard. J Cachexia Sarcopenia Muscle. 2018 Apr;9(2):269-278. doi: 10.1002/jcsm.12268. Epub 2018 Jan 19.
PubMed 29349935Wong AK. A Comparison of Peripheral Imaging Technologies for Bone and Muscle Quantification: a Mixed Methods Clinical Review. Curr Osteoporos Rep. 2016 Dec;14(6):359-373. doi: 10.1007/s11914-016-0334-z.
PubMed 27796924Mijnarends DM, Luiking YC, Halfens RJG, Evers SMAA, Lenaerts ELA, Verlaan S, Wallace M, Schols JMGA, Meijers JMM. Muscle, Health and Costs: A Glance at their Relationship. J Nutr Health Aging. 2018;22(7):766-773. doi: 10.1007/s12603-018-1058-9.
PubMed 30080217Schaap LA, van Schoor NM, Lips P, Visser M. Associations of Sarcopenia Definitions, and Their Components, With the Incidence of Recurrent Falling and Fractures: The Longitudinal Aging Study Amsterdam. J Gerontol A Biol Sci Med Sci. 2018 Aug 10;73(9):1199-1204. doi: 10.1093/gerona/glx245.
PubMed 29300839Malmstrom TK, Miller DK, Simonsick EM, Ferrucci L, Morley JE. SARC-F: a symptom score to predict persons with sarcopenia at risk for poor functional outcomes. J Cachexia Sarcopenia Muscle. 2016 Mar;7(1):28-36. doi: 10.1002/jcsm.12048. Epub 2015 Jul 7.
PubMed 27066316Chang KV, Hsu TH, Wu WT, Huang KC, Han DS. Association Between Sarcopenia and Cognitive Impairment: A Systematic Review and Meta-Analysis. J Am Med Dir Assoc. 2016 Dec 1;17(12):1164.e7-1164.e15. doi: 10.1016/j.jamda.2016.09.013. Epub 2016 Nov 2.
PubMed 27816484Antunes AC, Araujo DA, Verissimo MT, Amaral TF. Sarcopenia and hospitalisation costs in older adults: a cross-sectional study. Nutr Diet. 2017 Feb;74(1):46-50. doi: 10.1111/1747-0080.12287. Epub 2016 Jun 13.
PubMed 28731551Beaudart C, Rizzoli R, Bruyere O, Reginster JY, Biver E. Sarcopenia: burden and challenges for public health. Arch Public Health. 2014 Dec 18;72(1):45. doi: 10.1186/2049-3258-72-45. eCollection 2014.
PubMed 25810912Lourenco RA, Perez-Zepeda M, Gutierrez-Robledo L, Garcia-Garcia FJ, Rodriguez Manas L. Performance of the European Working Group on Sarcopenia in Older People algorithm in screening older adults for muscle mass assessment. Age Ageing. 2015 Mar;44(2):334-8. doi: 10.1093/ageing/afu192. Epub 2014 Dec 23.
PubMed 25539836Panagiotakos DB, Pitsavos C, Stefanadis C. Dietary patterns: a Mediterranean diet score and its relation to clinical and biological markers of cardiovascular disease risk. Nutr Metab Cardiovasc Dis. 2006 Dec;16(8):559-68. doi: 10.1016/j.numecd.2005.08.006. Epub 2006 Feb 9.
PubMed 17126772Soulis G, Zigkiri E, Perkisas S, Antoniou K, Maniati A, Galanos A, Georgiadis E, Koutsouri A. Muscle Mass Reference Values of Greek Adult Population: A Cross-Sectional Study for Sarcopenia Definition in Greece. J Musculoskelet Neuronal Interact. 2025 Dec 1;25(4):422-429. doi: 10.22540/JMNI-25-422.
PubMed 41324213
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appendicular Skeletal Muscle Mass Adult Reference Measurements in Greek Population
- ClinicalTrials.gov ID
- NCT04584944
- Acronym / sponsor ID
- SmmS / 3080234A
- Conditions
- Public Health, Sarcopenia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Henry Dunant Hospital CenterUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 14 Oct 2020 (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.
There is a lot of discussion concerning the normal cut-off points of skeletal mass among different populations worldwide. Genetic and environmental differences most probably lead to different measurements. Defining muscle mass in healthy young adults in Greece will provide information that can be used to determine normal ranges of muscle mass of both sexes and consequently define sarcopenia.
The aim of the study is to define appendicular skeletal muscle mass reference measurements in healthy young adults in Greece. These values can be used to determine sarcopenia cut-offs according to recommendations.
Detailed description
Introduction
The reduction of muscle mass in humans is obvious after the age of fifty, with a reduction rate of 3-8% every ten years. The rate of loss accelerates with chronic diseases, sedentary lifestyle, low physical activity, nutritional, environmental and socioeconomic factors .
Sarcopenia has been officially recognized as a disease according to World Health Organization. European Working Group on Sarcopenia in Older People 2 has revised the definition and diagnostic criteria of sarcopenia aiming to encourage more research in the field. In Greece, there are no reference values for muscle strength and muscle mass. Defining these values will permit the investigators to provide a tool that will help to establish country - specific measurements of sarcopenia in Greek population.
Study population-Methods
The study site will be the Outpatient Geriatric Assessment Unit and the Radiology Department of Henry Dunant Hospital Centre, in Athens-Greece.
The study population will be healthy adults that meet the inclusion criteria. The recruitment will be performed using the snowball sampling technique (for instance, through printed material, the marketing department of the hospital, social media, advertising banners, etc.). Stratified random sampling technique will be used to achieve a representative sample size.
Evaluation of the appendicular muscle mass of the limbs will be performed by Dual-Energy X-ray Absorptiometry, using a QDR-4500 A fan Beam densitometer (Hologic, Inc., Bedford, MA). Hologic Discovery W configured with software version 12.1 (Hologic, Bedford, MA).
Body composition analysis will be evaluated with TANITA Body Composition Analyzer device,model BC-418MA. Analysis concerns calculation of body consistency (body fat mass, lean mass water and predicted muscle mass) using Bioelectric Impedance Analysis. Bioelectric Impedance Analysis measures the body composition using a constant power source (high frequency current 50kHz, 90 μA).
Muscle mass will also be measured by ultrasound -U/S. U/S determines the thickness and transverse incisions of a superficial muscle group. It can measure basic parameters such as muscle volume and spectrum length through the B-Mode imaging with Linear 7-12MHz frequency heads that can reliably determine the thickness and transverse incisions of the superficial muscular Groups.
Statistical analysis
It will be performed using the Statistical Package for the Social Sciences -SPSS Version 26.0 (IBM), and R Version 3.6.2.
Descriptive statistics will be presented in percentage proportions, mean values and Standard Deviations (SD) of the variables. In addition, Z-score will be calculated (e.g. Dual-energy X-ray absorptiometry , Bone Mineral density, Dual-energy X-ray absorptiometry % fat, etc.) and T-score ± 2 standard deviations.
Chi-square - χ2 tests or non-parametric tests will be produced to compare qualitative variables. T-test, Analysis of Variance- ANOVA and non-parametric tests will be used in the statistical analysis of quantitative variables within the categories of qualitative variables.
Approval
The protocol has been approved by the Scientific Committee of the Henry Dunant Hospital Centre, in Athens -Greece, and is in accordance with the Code of Ethics of the World Organization for Medical Sciences (CIOMS) as formulated in the Helsinki Declaration on Biological Research.
Informed consent
All participants will be informed in written for the purpose of the research, and the way their personal data are processed (name, address, telephone, e-mail), under the provisions of 2016/679 according to the General Data Protection Regulation (GDPR).
The consent form will describe the legal and transparent way of processing their data, stating the specific purpose for data collection, as well as information about storage of their data. It will also contain a written description of the rights of the participants concerning their data and their ability to revoke consent for the processing of their data. The processing, transfer and storage of data, will also be described, as well as who will have access to their data, and how long the data will be stored for.
Finally, all participants will sign the written informed consent and confidentiality form.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy adult men | – | Radiation: Dual energy X-ray absorptiometryHealthy young men, 20- 44 years old |
| Healthy adult women | – | Radiation: Dual energy X-ray absorptiometryHealthy young women, 20- 44 years old |
Who may qualify
- Ages
- 20 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population will be healthy adults that meet the inclusion criteria and can have access to the study site. The recruitment will be performed using the snowball sampling technique (for instance, through printed material, the marketing department of the hospital, social media (Facebook/Instagram/Twitter), advertising banners, etc.). We will also invite participants from nearby academic institutions, organizations, municipalities, etc. It is foreseen to include 500 participants in the study.
Key inclusion criteria (2 listed)
- Healthy Greek young adults (20 - 44 years old), with Caucasian characteristics.
- Able to read and write in Greek language.
Key exclusion criteria (18 listed)
- Chronic diseases, such as, heart diseases, type II diabetes mellitus and autoimmune diseases.
- Hyperthyroidism or hypothyroidism (persons with normal thyroid function for six months are included).
- Malignancies.
- Seizures of epilepsy, neurodegenerative diseases.
- Asthma and/or chronic respiratory pulmonary disease-Chronic Obstructive Pulmonary Disease.
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 |
|---|---|---|
| Dual energy X-ray absorptiometryAlso: Bioelectrical Impedance Analysis, UltrasoundEvaluation of the appendicular muscle mass of the limbs will be performed by Dual-Energy X-ray Absorptiometry, using a QDR 4500. Body composition analysis will also be evaluated with TANITA Body Composition Analyzer device,model BC-418MA. Bioelectrical Impedance Analysis measures the body composition using a constant power source (high frequency current 50kHz, 90 μA). Muscle mass is also going to be measured by using ultrasound -U/S. It measures basic parameters such as muscle volume and spectrum length through the B-Mode imaging with Linear 7-12MHz frequency heads that can reliably determine the thickness and transverse incisions of the superficial muscular Groups. | Radiation | Healthy adult men, Healthy adult women |
Primary outcome
Appendicular skeletal muscle mass reference measurements of healthy young adults in Greece
Time frame: 01/06/2022
Measurements of appendicular skeletal muscle mass of healthy young adults in Greece that will be used to define sarcopenia in older adults and as normative values.
Define reference measurements for muscle strength.
Time frame: 01/06/2022
Reference measurements for hand grip
Define reference measurements for muscle performance
Time frame: 01/06/2022
Reference measurements for walking speed
5 secondary outcomes
Correlations between the different tools used to measure muscle mass
Time frame: 01/06/2022
Correlation of muscle mass with demographic characteristics
Time frame: 01/06/2022
Correlation of bone mass with demographic characteristics
Time frame: 01/06/2022
Correlation of fat mass with demographic characteristics
Time frame: 01/06/2022
Correlation of adherence to Mediterranean diet with muscle mass
Time frame: 01/06/2022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Results publication: PubMed 31081853Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jul 1;48(4):601. doi: 10.1093/ageing/afz046. No abstract available.
- Results publication: PubMed 29349935Buckinx F, Landi F, Cesari M, Fielding RA, Visser M, Engelke K, Maggi S, Dennison E, Al-Daghri NM, Allepaerts S, Bauer J, Bautmans I, Brandi ML, Bruyere O, Cederholm T, Cerreta F, Cherubini A, Cooper C, Cruz-Jentoft A, McCloskey E, Dawson-Hughes B, Kaufman JM, Laslop A, Petermans J, Reginster JY, Rizzoli R, Robinson S, Rolland Y, Rueda R, Vellas B, Kanis JA. Pitfalls in the measurement of muscle mass: a need for a reference standard. J Cachexia Sarcopenia Muscle. 2018 Apr;9(2):269-278. doi: 10.1002/jcsm.12268. Epub 2018 Jan 19.
- Results publication: PubMed 27796924Wong AK. A Comparison of Peripheral Imaging Technologies for Bone and Muscle Quantification: a Mixed Methods Clinical Review. Curr Osteoporos Rep. 2016 Dec;14(6):359-373. doi: 10.1007/s11914-016-0334-z.
- Results publication: PubMed 30080217Mijnarends DM, Luiking YC, Halfens RJG, Evers SMAA, Lenaerts ELA, Verlaan S, Wallace M, Schols JMGA, Meijers JMM. Muscle, Health and Costs: A Glance at their Relationship. J Nutr Health Aging. 2018;22(7):766-773. doi: 10.1007/s12603-018-1058-9.
- Results publication: PubMed 29300839Schaap LA, van Schoor NM, Lips P, Visser M. Associations of Sarcopenia Definitions, and Their Components, With the Incidence of Recurrent Falling and Fractures: The Longitudinal Aging Study Amsterdam. J Gerontol A Biol Sci Med Sci. 2018 Aug 10;73(9):1199-1204. doi: 10.1093/gerona/glx245.
- Results publication: PubMed 27066316Malmstrom TK, Miller DK, Simonsick EM, Ferrucci L, Morley JE. SARC-F: a symptom score to predict persons with sarcopenia at risk for poor functional outcomes. J Cachexia Sarcopenia Muscle. 2016 Mar;7(1):28-36. doi: 10.1002/jcsm.12048. Epub 2015 Jul 7.
- Results publication: PubMed 27816484Chang KV, Hsu TH, Wu WT, Huang KC, Han DS. Association Between Sarcopenia and Cognitive Impairment: A Systematic Review and Meta-Analysis. J Am Med Dir Assoc. 2016 Dec 1;17(12):1164.e7-1164.e15. doi: 10.1016/j.jamda.2016.09.013. Epub 2016 Nov 2.
- Results publication: PubMed 28731551Antunes AC, Araujo DA, Verissimo MT, Amaral TF. Sarcopenia and hospitalisation costs in older adults: a cross-sectional study. Nutr Diet. 2017 Feb;74(1):46-50. doi: 10.1111/1747-0080.12287. Epub 2016 Jun 13.
- Results publication: PubMed 25810912Beaudart C, Rizzoli R, Bruyere O, Reginster JY, Biver E. Sarcopenia: burden and challenges for public health. Arch Public Health. 2014 Dec 18;72(1):45. doi: 10.1186/2049-3258-72-45. eCollection 2014.
- Results publication: PubMed 25539836Lourenco RA, Perez-Zepeda M, Gutierrez-Robledo L, Garcia-Garcia FJ, Rodriguez Manas L. Performance of the European Working Group on Sarcopenia in Older People algorithm in screening older adults for muscle mass assessment. Age Ageing. 2015 Mar;44(2):334-8. doi: 10.1093/ageing/afu192. Epub 2014 Dec 23.
- Results publication: PubMed 17126772Panagiotakos DB, Pitsavos C, Stefanadis C. Dietary patterns: a Mediterranean diet score and its relation to clinical and biological markers of cardiovascular disease risk. Nutr Metab Cardiovasc Dis. 2006 Dec;16(8):559-68. doi: 10.1016/j.numecd.2005.08.006. Epub 2006 Feb 9.
- Derived from this study: PubMed 41324213Soulis G, Zigkiri E, Perkisas S, Antoniou K, Maniati A, Galanos A, Georgiadis E, Koutsouri A. Muscle Mass Reference Values of Greek Adult Population: A Cross-Sectional Study for Sarcopenia Definition in Greece. J Musculoskelet Neuronal Interact. 2025 Dec 1;25(4):422-429. doi: 10.22540/JMNI-25-422.
- Individual participant dataSharing planned: No
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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.
Anastasia Koutsouri study chair
Head of the Outpatient Geriatric Assessment Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Public Health and Sarcopenia, run by Henry Dunant Hospital Center at 1 site in Greece.
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 18 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: status not confirmed, as of the sponsor's last update on 14 Oct 2020. 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 Greece. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anastasia Koutsouri (00306944413656, nkalamak@yahoo.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appendicular skeletal muscle mass reference measurements of healthy young adults in Greece (time frame: 01/06/2022). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04584944, which also lists 12 linked publications.
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 14 Oct 2020.