Sarcopenic ObesityNCT06120647
Molecular Mechanisms Underpinning Sarcopenic Obesity
An observational study of Sarcopenic Obesity and Obesity, run by The Swedish School of Sport and Health Sciences at 1 site in Sweden.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sarcopenic Obesity, Obesity, Sarcopenia
- What is being tested?
- Essential amino acids (EAA)
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- 28 Jan 2020to 30 Dec 2025
- 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 18 to 80 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
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- Present infection
- Dementia or delirium
- Other conditions that may interfere with the study protocol in the opinion of the PI
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
The Swedish School of Sport and Health Sciences
Stockholm, 11433
Oscar Horwath, MSc, oscar.horwath@gih.se
About this study
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.
- Conditions
- Sarcopenic Obesity, Obesity, Sarcopenia, Aging
- Being tested
- Essential amino acids (EAA)
- Medical subject headings
- Obesity, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Essential amino acids (EAA)Dietary supplement
intake of 240 mg EAA per kg lean body mass after a resistance exercise session
| Study group | Role | What they receive |
|---|---|---|
| Sarcopenic obesity | Age: 70-80 years Men, ALM/W < 25.7 %, body fat % > 35 Women, ALM/W < 19.7 %, body fat % > 40 Receives: 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 Receives: 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 Receives: 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 Receives: Dietary Supplement: Essential amino acids (EAA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 hour after ingestion of essential amino acids and resistance exercise
Secondary outcomes (5)
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).
Measured: 1 hour prior to ingestion of essential amino acids and resistance exercise
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).
Measured: 1 hour
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.
Measured: 2 hours
Accelerometer-assessed physical activity levels
Hip-worn accelerometer data (Actigraph GT3X) collected over 7 consecutive days. Unit of measurement is steps per day.
Measured: 1 week
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).
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start28 Jan 2020
- Primary completion15 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcopenic ObesityStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Swedish School of Sport and Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Apro, The Swedish School of Sport and Health Sciences
- Investigators
- William Apró, PhD, Principal investigator, The Swedish School of Sport and Health Sciences and Karolinska Institute, Stockholm Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06120647
- Sponsor's protocol ID
- 2019-04016
- Other IDs
- 2019
- Status last verified
- Dec 2023
- First submitted
- 10 Oct 2023
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Mechanisms Underpinning Sarcopenic Obesity
- ClinicalTrials.gov ID
- NCT06120647
- Acronym / sponsor ID
- 2019-04016
- Conditions
- Sarcopenic Obesity, Obesity, Sarcopenia, Aging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Swedish School of Sport and Health SciencesUniversity, hospital or other
- Study start
- 28 Jan 2020 (actual)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 7 Nov 2023 (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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sarcopenic obesity | – | Dietary Supplement: Essential amino acids (EAA)Age: 70-80 years Men, ALM/W < 25.7 %, body fat % > 35 Women, ALM/W < 19.7 %, body fat % > 40 |
| Non-sarcopenic obese | – | Dietary Supplement: Essential amino acids (EAA)Age: 70-80 years Men, ALM/W > 25.7 %, body fat % > 35 Women, ALM/W > 19.7 %, body fat % > 40 |
| Non-sarcopenic lean | – | Dietary Supplement: Essential amino acids (EAA)Age: 70-80 years Men, ALM > 7.0 kg/m2, body fat % < 25 Women, ALM > 5.5 kg/m2, body fat % < 32 |
| Young lean | – | Dietary Supplement: Essential amino acids (EAA)Age: 18-40 years Men, ALM > 7.0 kg/m2, body fat % < 25 Women, ALM > 5.5 kg/m2, body fat % < 32 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| Essential amino acids (EAA)intake of 240 mg EAA per kg lean body mass after a resistance exercise session | Dietary supplement | Non-sarcopenic lean, Non-sarcopenic obese, Sarcopenic obesity, Young lean |
Primary outcome
Fiber type-specific cell signalling
Time frame: 1 hour after ingestion of essential amino acids and resistance exercise
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).
5 secondary outcomes
Skeletal muscle fiber characteristics
Time frame: 1 hour prior to ingestion of essential amino acids and resistance exercise
Whole body muscle volume
Time frame: 1 hour
Whole body glucose tolerance
Time frame: 2 hours
Accelerometer-assessed physical activity levels
Time frame: 1 week
Isometric and isokinetic leg muscle strength
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
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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.
William Apró, PhD principal investigator
The Swedish School of Sport and Health Sciences and Karolinska Institute, Stockholm Sweden
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 Sarcopenic Obesity and Obesity, run by The Swedish School of Sport and Health Sciences at 1 site in Sweden.
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 4 inclusion and 9 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 11 Dec 2023. 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 Sweden. 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 William Apró, PhD (08-120 538 67 ext. +46, william.apro@gih.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fiber type-specific cell signalling (time frame: 1 hour after ingestion of essential amino acids and resistance exercise). 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 11 Dec 2023.