NCT06120647

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 28, 2020

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

October 10, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

December 11, 2023

Status Verified

December 1, 2023

Enrollment Period

5.9 years

First QC Date

October 10, 2023

Last Update Submit

December 4, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Skeletal muscle fiber characteristics

    1 hour prior to ingestion of essential amino acids and resistance exercise

  • Whole body muscle volume

    1 hour

  • Whole body glucose tolerance

    2 hours

  • Accelerometer-assessed physical activity levels

    1 week

  • Isometric and isokinetic leg muscle strength

    1 hour

Study Arms (4)

Sarcopenic obesity

Age: 70-80 years Men, ALM/W \< 25.7 %, body fat % \> 35 Women, ALM/W \< 19.7 %, body fat % \> 40

Dietary Supplement: Essential amino acids (EAA)

Non-sarcopenic obese

Age: 70-80 years Men, ALM/W \> 25.7 %, body fat % \> 35 Women, ALM/W \> 19.7 %, body fat % \> 40

Dietary Supplement: Essential amino acids (EAA)

Non-sarcopenic lean

Age: 70-80 years Men, ALM \> 7.0 kg/m2, body fat % \< 25 Women, ALM \> 5.5 kg/m2, body fat % \< 32

Dietary Supplement: Essential amino acids (EAA)

Young lean

Age: 18-40 years Men, ALM \> 7.0 kg/m2, body fat % \< 25 Women, ALM \> 5.5 kg/m2, body fat % \< 32

Dietary Supplement: Essential amino acids (EAA)

Interventions

Essential amino acids (EAA)DIETARY_SUPPLEMENT

intake of 240 mg EAA per kg lean body mass after a resistance exercise session

Non-sarcopenic leanNon-sarcopenic obeseSarcopenic obesityYoung lean

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The elderly participants will be community-dwelling living in the greater Stockholm metropolitan area. Participants will be recruited through local senior clubs, online communities, advertisement and word of mouth. The young participants will be living in the greater Stockholm metropolitan area. Participants will be recruited through university forums, online communities, advertisement and word of mouth.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Swedish School of Sport and Health Sciences

Stockholm, 11433, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Skeletal muscle biopsies from m. vastus lateralis and venous blood samples

MeSH Terms

Conditions

ObesitySarcopenia

Interventions

Amino Acids, Essential

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Amino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • William Apró, PhD

    The Swedish School of Sport and Health Sciences and Karolinska Institute, Stockholm Sweden

    PRINCIPAL INVESTIGATOR

Central Study Contacts

William Apró, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 10, 2023

First Posted

November 7, 2023

Study Start

January 28, 2020

Primary Completion

December 15, 2025

Study Completion

December 30, 2025

Last Updated

December 11, 2023

Record last verified: 2023-12

Locations