Appendicular Skeletal Muscle Mass Study

NCT04584944 | Unknown

• 1 other identifier: 3080234A
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Public Health; Sarcopenia

Outcome Measures

Primary Outcomes (3)

• 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.

  01/06/2022

• Define reference measurements for muscle strength.

  Reference measurements for hand grip

  01/06/2022

• Define reference measurements for muscle performance

  Reference measurements for walking speed

  01/06/2022

Secondary Outcomes (5)

• Correlations between the different tools used to measure muscle mass

  01/06/2022

• Correlation of muscle mass with demographic characteristics

  01/06/2022

• Correlation of bone mass with demographic characteristics

  01/06/2022

• Correlation of fat mass with demographic characteristics

  01/06/2022

• Correlation of adherence to Mediterranean diet with muscle mass

  01/06/2022

Study Arms (2)

Healthy adult men

Healthy young men, 20- 44 years old

Radiation: Dual energy X-ray absorptiometry

Healthy adult women

Healthy young women, 20- 44 years old

Radiation: Dual energy X-ray absorptiometry

Interventions

Dual energy X-ray absorptiometry RADIATION

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.

Also known as: Bioelectrical Impedance Analysis, Ultrasound

Healthy adult men; Healthy adult women

Eligibility Criteria

• Age: 20 Years - 44 Years
• Gender Eligibility Details: Gender identity
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Healthy Greek young adults (20 - 44 years old), with Caucasian characteristics.
• Able to read and write in Greek language.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Henry Dunant Hospital Center: lead

Study Sites (1)

Henry Dunant Hospital Center

Athens, Greece

RECRUITING

Related Publications (12)

• 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.

  PMID: 31081853 RESULT

• Buckinx 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.

  PMID: 29349935 RESULT

• Wong 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.

  PMID: 27796924 RESULT

• Mijnarends 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.

  PMID: 30080217 RESULT

• Schaap 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.

  PMID: 29300839 RESULT

• Malmstrom 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.

  PMID: 27066316 RESULT

• Chang 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.

  PMID: 27816484 RESULT

• Antunes 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.

  PMID: 28731551 RESULT

• Beaudart 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.

  PMID: 25810912 RESULT

• Lourenco 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.

  PMID: 25539836 RESULT

• Panagiotakos 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.

  PMID: 17126772 RESULT

• Soulis 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.

  PMID: 41324213 DERIVED

MeSH Terms

Conditions

Sarcopenia

Interventions

Absorptiometry, Photon; High-Energy Shock Waves

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques; Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Anastasia Koutsouri

  Head of the Outpatient Geriatric Assessment Unit

  STUDY CHAIR

Central Study Contacts

Anastasia Koutsouri

CONTACT

00306944413656; nkalamak@yahoo.gr

Georgios Soulis

CONTACT

00306947123967; geosoulis@yahoo.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: October 14, 2020
• Study Start: June 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: June 30, 2022
• Last Updated: October 14, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)