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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06120647
Other study ID # 2019-04016
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 28, 2020
Est. completion date December 30, 2025

Study information

Verified date December 2023
Source The Swedish School of Sport and Health Sciences
Contact William Apró, PhD
Phone 08-120 538 67
Email william.apro@gih.se
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The coexistence of obesity and sarcopenia results in sarcopenic obesity, a high-risk geriatric condition associated with metabolic perturbations and several co-morbidities. Despite the rising numbers of older adults diagnosed with sarcopenic obesity, few studies have characterized this condition on the muscle cell and systemic level. This study sought to comprehensively assess the influence of sarcopenic obesity on muscle and blood-related parameters and compare it to non-sarocopenic obese and non-sarcopenic lean older adults.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 30, 2025
Est. primary completion date December 15, 2025
Accepts healthy volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Body fat % in accordance with previously defined criteria - Free of smoking (since 10 years) - Able to walk without assistance - Able to perform bilateral leg extension exercise Exclusion Criteria: - History of or present disease of myocardial, vascular, endocrine, hepatic, renal, pulmonary or neuromuscular origin - Uncontrolled hypo/hypertension - Use of anticoagulants (Warfarin, Trombyl) - Use of metformin or other anti-diabetic medications - Poor appetite and unexplained weight loss (4,5 kg) over the past 6 months - Active malignancy - Present infection - Dementia or delirium - Other conditions that may interfere with the study protocol in the opinion of the PI

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Essential amino acids (EAA)
intake of 240 mg EAA per kg lean body mass after a resistance exercise session

Locations

Country Name City State
Sweden The Swedish School of Sport and Health Sciences Stockholm

Sponsors (1)

Lead Sponsor Collaborator
The Swedish School of Sport and Health Sciences

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fiber type-specific cell signalling This measure will be investigated during an experimental trial in which the participants are subjected to an acute bout of resistance exercise followed by the ingestion of essential amino acids (240 mg/kg lean mass). During this 3 hour time period, the participants will donate two muscle biopsies, one before exercise and the second one 1 hour after exercise. Cell signalling networks related to muscle mass regulation will be examined in these biopsy samples. The signal will be measured using Western blotting and the signal obtained is expressed in relation to baseline (adjusted volume intensity). 1 hour after ingestion of essential amino acids and resistance exercise
Secondary Skeletal muscle fiber characteristics Fiber type-specific area measured using immunofluorescence microscope in muscle biopsies collected at baseline (prior to ingestion of essential amino acids and resistance exercise). Unit of measurement is square micrometers (µm^2). 1 hour prior to ingestion of essential amino acids and resistance exercise
Secondary Whole body muscle volume Indices of muscle volume and fat infiltration obtained with magnetic resonance imaging (MRI). Unit of measurement is cubic centrimeters (cm^3). 1 hour
Secondary Whole body glucose tolerance Oral glucose tolerance test in which the participants will ingest a standardized glucose drink and blood glucose levels will be monitored throughout a period of 2 hours. Unit of measurement is mmol/L glucose. 2 hours
Secondary Accelerometer-assessed physical activity levels Hip-worn accelerometer data (Actigraph GT3X) collected over 7 consecutive days. Unit of measurement is steps per day. 1 week
Secondary Isometric and isokinetic leg muscle strength Muscle performance will be evaluated at a single timepoint during the study using IsoMed2000 dynamometer. Participants will perform a maximal isometric contraction at 60 degrees of knee flexion. Unit of measurement is Newton meter (N-m). 1 hour
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