Obesity (BMI>30)TAUMUSCLENCT07730255
Exercise and Taurine Supplementation on Intramuscular Fat in Older Women With Obesity
A study testing Concurrent Exercise Training and Taurine in people with Obesity (BMI>30), run by University of Sao Paulo at 1 site in Brazil.
Trial summary
This randomized clinical trial aims to investigate the effects of multicomponent concurrent exercise training associated or not with taurine supplementation on intramuscular fat infiltration, physical performance, transcriptomic profile, and metabolomic profile in older women with obesity. Read more about this study
- Who is it for?
- Ages 60 to 75 years, women only
- Conditions the study is for
- Obesity (BMI>30)
- What is being tested?
- Concurrent Exercise Training and Taurine
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteBrazil
- Study dates
- 1 May 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female,
- 60 and 75 years of age,
- Body mass lower than 120 kg,
- Be sedentary (not having engaged in physical exercise for at least 3 months), and
- Body Mass Index between 30 and 40 kg/m².
Who cannot join
- alcohol consumption,
- smoking,
- infectious and contagious diseases,
- chronic kidney diseases,
- undergoing weight loss treatment, and
- presenting a score ≤13 on cognitive screening using the Mini-Mental State Examination (MMSE).
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Escola de Educação Física e Esporte de Ribeirão Preto, Ribeirão Preto, São Paulo.
Ribeirão Preto, São Paulo, 14040-900
About this study
Official title: The Impact of Physical Exercise Associated or Not With Taurine Supplementation on Intramuscular Fat Infiltration in Older Women With Obesity: A Transcriptomic and Metabolomic Approach
This randomized clinical trial aims to investigate the effects of multicomponent concurrent exercise training associated or not with taurine supplementation on intramuscular fat infiltration, physical performance, transcriptomic profile, and metabolomic profile in older women with obesity. Forty women aged 60 to 75 years with obesity will be randomized into four groups: control, exercise, taurine, and exercise plus taurine. The intervention will last 16 weeks. Outcomes include magnetic resonance imaging, body composition, muscle biopsy, blood biomarkers, functional capacity tests, transcriptomic analysis, and metabolomic analysis.
Read the detailed description
Aging and obesity are associated with important physiological, metabolic, and functional alterations, including increased intramuscular fat infiltration, also known as myosteatosis. Intramuscular fat infiltration is associated with reduced muscle quality, impaired physical performance, metabolic dysfunction, insulin resistance, and increased risk of morbidity and mortality in older adults.
Physical exercise is recognized as an important non-pharmacological strategy to improve muscle function and metabolic health. In addition, taurine supplementation has demonstrated anti-inflammatory and metabolic effects that may contribute to the reduction of intramuscular fat accumulation and improvement of skeletal muscle health.
However, the synergistic effects of concurrent exercise training associated with taurine supplementation on intramuscular fat infiltration and molecular mechanisms involved in older women with obesity are still unclear.
Therefore, this randomized clinical trial aims to investigate the effects of physical exercise associated or not with taurine supplementation on intramuscular fat infiltration, physical performance, body composition, transcriptomic profile, and metabolomic profile in older women with obesity.
Forty women aged 60 to 75 years with obesity (Body mass index - BMI between 30 and 40 kg/m²) will be randomized into four groups:
- Control group;
- Exercise group;
- Taurine supplementation group;
- Exercise plus taurine supplementation group. The intervention will last 16 weeks. Participants allocated to exercise groups will perform supervised concurrent exercise training three times per week, including resistance and aerobic exercises. Participants allocated to taurine groups will receive 3 grams per day taurine supplementation.
Assessments performed before and after the intervention will include magnetic resonance imaging for intramuscular fat evaluation, body composition by dual-energy X-ray absorptiometry (DXA), muscle biopsy, blood biomarkers, indirect calorimetry, functional capacity tests, muscle strength, transcriptomic analysis, and metabolomic analysis.
This study may contribute to the development of innovative non-pharmacological strategies for obesity, aging, and intramuscular fat infiltration management.
- Conditions
- Obesity (BMI>30)
- Being tested
- Concurrent Exercise Training, Taurine, Placebo
- Keywords
- Obesity, Taurine, Physical Exercise, Intramuscular Fat Infiltration, Transcriptomics, Metabolomics
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concurrent Exercise TrainingBehavioural
Participants will perform supervised concurrent exercise training three times per week for 16 weeks. Exercise sessions will include warm-up, resistance exercises, aerobic training, and stretching exercises, according to American College of Sports Medicine (ACSM) recommendations for older adults.
TaurineDietary supplement
Participants will receive 3 grams per day taurine supplementation administered orally in capsules for 16 weeks.
PlaceboOther
Participants will receive placebo capsules identical in appearance to taurine capsules.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Participants will not receive exercise training or taurine supplementation, only the placebo. Receives: Other: Placebo |
| Exercise group | Experimental | Participants will undergo supervised concurrent exercise training three times per week for 16 weeks and will receive placebo. Receives: Behavioral: Concurrent Exercise Training; Other: Placebo |
| Taurine supplementation group | Experimental | Participants will receive 3 grams per day taurine supplementation for 16 weeks. Receives: Dietary Supplement: Taurine |
| Exercise plus taurine supplementation group | Experimental | Participants will undergo supervised multicomponent concurrent exercise training combined with 3 grams per day taurine supplementation for 16 weeks. Receives: Behavioral: Concurrent Exercise Training; Dietary Supplement: Taurine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Intramuscular Fat Fraction Assessed by Magnetic Resonance Imaging (Dixon Technique)
Intramuscular fat fraction assessed by magnetic resonance imaging (MRI) using the Dixon technique, reported as percentage (%) of fat within the muscle tissue. Change is calculated from baseline to Week 16.
Measured: Baseline and 16 weeks
Change from baseline in skeletal muscle transcriptomic profile
Skeletal muscle biopsy samples will be analyzed using RNA sequencing to characterize changes in the skeletal muscle transcriptomic profile following the intervention.
Measured: Baseline and 16 weeks
Change from baseline in plasma metabolomic profile
Plasma samples will be analyzed using untargeted metabolomic analysis to evaluate changes in the plasma metabolomic profile after 16 weeks of intervention.
Measured: 16 weeks
Change from baseline in plasma taurine concentration
Plasma taurine concentration will be measured before and after the 16-week intervention.
Measured: Baseline and 16 weeks
Secondary outcomes (14)
Change from baseline in Timed Up and Go test time
Functional mobility will be assessed using the Timed Up and Go test.
Measured: Baseline and 16 weeks
Change from baseline in handgrip strength
Handgrip strength will be assessed using a hand dynamometer.
Measured: Baseline and 16 weeks
Change from baseline in chair stand test performance
Lower-body functional performance will be assessed using the Chair Stand Test.
Measured: Baseline and 16 weeks
Change from baseline in forearm flexion test performance
Upper-body muscular endurance will be assessed using the Forearm Flexion Test.
Measured: Baseline and 16 weeks
Change from baseline in isokinetic knee extensor peak torque
Peak torque of the knee extensor muscles will be measured using an isokinetic dynamometer.
Measured: Baseline and 16 weeks
Change from baseline in fat-free mass
Fat-free mass will be assessed by dual-energy X-ray absorptiometry.
Measured: Baseline and 16 weeks
Change from baseline in fat mass
Fat mass will be assessed by dual-energy X-ray absorptiometry.
Measured: Baseline and 16 weeks
Change from baseline in fasting blood glucose concentration
Fasting blood glucose concentration will be measured using blood samples collected after an overnight fast.
Measured: Baseline and 16 weeks
Change from baseline in fasting insulin concentration
Fasting insulin concentration will be measured using blood samples collected after an overnight fast.
Measured: Baseline and 16 weeks
Change from baseline in total cholesterol concentration
Total cholesterol concentration will be measured using fasting blood samples.
Measured: Baseline and 16 weeks
Change from baseline in high-density lipoprotein cholesterol concentration
High-density lipoprotein cholesterol concentration will be measured using fasting blood samples.
Measured: Baseline and 16 weeks
Change from baseline in low-density lipoprotein cholesterol concentration
Low-density lipoprotein cholesterol concentration will be measured using fasting blood samples.
Measured: Baseline and 16 weeks
Change from baseline in triglyceride concentration
Triglyceride concentration will be measured using fasting blood samples.
Measured: Baseline and 16 weeks
Change from baseline in resting metabolic rate
Resting metabolic will be assessed by indirect calorimetry after an overnight fast.
Measured: Baseline and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start1 May 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity (BMI>30)Studies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ellen Cristini de Freitas, University of Sao Paulo
- Investigators
- Ellen C de Freitas, Doctor, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07730255
- Sponsor's protocol ID
- CAAE: 93008225.6.0000.5659
- Acronym
- TAUMUSCLE
- Status last verified
- May 2026
- First submitted
- 21 May 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Physical Exercise Associated or Not With Taurine Supplementation on Intramuscular Fat Infiltration in Older Women With Obesity: A Transcriptomic and Metabolomic Approach
- ClinicalTrials.gov ID
- NCT07730255
- Acronym / sponsor ID
- TAUMUSCLE / CAAE: 93008225.6.0000.5659
- Conditions
- Obesity (BMI>30)
- Keywords
- Obesity, Taurine, Physical Exercise, Intramuscular Fat Infiltration, Transcriptomics, Metabolomics
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 Jul 2026 (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.
This randomized clinical trial aims to investigate the effects of multicomponent concurrent exercise training associated or not with taurine supplementation on intramuscular fat infiltration, physical performance, transcriptomic profile, and metabolomic profile in older women with obesity. Forty women aged 60 to 75 years with obesity will be randomized into four groups: control, exercise, taurine, and exercise plus taurine. The intervention will last 16 weeks. Outcomes include magnetic resonance imaging, body composition, muscle biopsy, blood biomarkers, functional capacity tests, transcriptomic analysis, and metabolomic analysis.
Detailed description
Aging and obesity are associated with important physiological, metabolic, and functional alterations, including increased intramuscular fat infiltration, also known as myosteatosis. Intramuscular fat infiltration is associated with reduced muscle quality, impaired physical performance, metabolic dysfunction, insulin resistance, and increased risk of morbidity and mortality in older adults.
Physical exercise is recognized as an important non-pharmacological strategy to improve muscle function and metabolic health. In addition, taurine supplementation has demonstrated anti-inflammatory and metabolic effects that may contribute to the reduction of intramuscular fat accumulation and improvement of skeletal muscle health.
However, the synergistic effects of concurrent exercise training associated with taurine supplementation on intramuscular fat infiltration and molecular mechanisms involved in older women with obesity are still unclear.
Therefore, this randomized clinical trial aims to investigate the effects of physical exercise associated or not with taurine supplementation on intramuscular fat infiltration, physical performance, body composition, transcriptomic profile, and metabolomic profile in older women with obesity.
Forty women aged 60 to 75 years with obesity (Body mass index - BMI between 30 and 40 kg/m²) will be randomized into four groups:
- Control group;
- Exercise group;
- Taurine supplementation group;
- Exercise plus taurine supplementation group. The intervention will last 16 weeks. Participants allocated to exercise groups will perform supervised concurrent exercise training three times per week, including resistance and aerobic exercises. Participants allocated to taurine groups will receive 3 grams per day taurine supplementation.
Assessments performed before and after the intervention will include magnetic resonance imaging for intramuscular fat evaluation, body composition by dual-energy X-ray absorptiometry (DXA), muscle biopsy, blood biomarkers, indirect calorimetry, functional capacity tests, muscle strength, transcriptomic analysis, and metabolomic analysis.
This study may contribute to the development of innovative non-pharmacological strategies for obesity, aging, and intramuscular fat infiltration management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Other: PlaceboParticipants will not receive exercise training or taurine supplementation, only the placebo. |
| Exercise group | Experimental | Behavioral: Concurrent Exercise Training, Other: PlaceboParticipants will undergo supervised concurrent exercise training three times per week for 16 weeks and will receive placebo. |
| Taurine supplementation group | Experimental | Dietary Supplement: TaurineParticipants will receive 3 grams per day taurine supplementation for 16 weeks. |
| Exercise plus taurine supplementation group | Experimental | Behavioral: Concurrent Exercise Training, Dietary Supplement: TaurineParticipants will undergo supervised multicomponent concurrent exercise training combined with 3 grams per day taurine supplementation for 16 weeks. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female,
- 60 and 75 years of age,
- Body mass lower than 120 kg,
- Be sedentary (not having engaged in physical exercise for at least 3 months), and
- Body Mass Index between 30 and 40 kg/m².
Key exclusion criteria (6 listed)
- alcohol consumption,
- smoking,
- infectious and contagious diseases,
- chronic kidney diseases,
- undergoing weight loss treatment, and
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 |
|---|---|---|
| Concurrent Exercise TrainingParticipants will perform supervised concurrent exercise training three times per week for 16 weeks. Exercise sessions will include warm-up, resistance exercises, aerobic training, and stretching exercises, according to American College of Sports Medicine (ACSM) recommendations for older adults. | Behavioural | Exercise group, Exercise plus taurine supplementation group |
| TaurineParticipants will receive 3 grams per day taurine supplementation administered orally in capsules for 16 weeks. | Dietary supplement | Exercise plus taurine supplementation group, Taurine supplementation group |
| PlaceboParticipants will receive placebo capsules identical in appearance to taurine capsules. | Other | Control group, Exercise group |
Primary outcome
Change from Baseline in Intramuscular Fat Fraction Assessed by Magnetic Resonance Imaging (Dixon Technique)
Time frame: Baseline and 16 weeks
Intramuscular fat fraction assessed by magnetic resonance imaging (MRI) using the Dixon technique, reported as percentage (%) of fat within the muscle tissue. Change is calculated from baseline to Week 16.
Change from baseline in skeletal muscle transcriptomic profile
Time frame: Baseline and 16 weeks
Skeletal muscle biopsy samples will be analyzed using RNA sequencing to characterize changes in the skeletal muscle transcriptomic profile following the intervention.
Change from baseline in plasma metabolomic profile
Time frame: 16 weeks
Plasma samples will be analyzed using untargeted metabolomic analysis to evaluate changes in the plasma metabolomic profile after 16 weeks of intervention.
Change from baseline in plasma taurine concentration
Time frame: Baseline and 16 weeks
Plasma taurine concentration will be measured before and after the 16-week intervention.
14 secondary outcomes
Change from baseline in Timed Up and Go test time
Time frame: Baseline and 16 weeks
Change from baseline in handgrip strength
Time frame: Baseline and 16 weeks
Change from baseline in chair stand test performance
Time frame: Baseline and 16 weeks
Change from baseline in forearm flexion test performance
Time frame: Baseline and 16 weeks
Change from baseline in isokinetic knee extensor peak torque
Time frame: Baseline and 16 weeks
Change from baseline in fat-free mass
Time frame: Baseline and 16 weeks
Change from baseline in fat mass
Time frame: Baseline and 16 weeks
Change from baseline in fasting blood glucose concentration
Time frame: Baseline and 16 weeks
Change from baseline in fasting insulin concentration
Time frame: Baseline and 16 weeks
Change from baseline in total cholesterol concentration
Time frame: Baseline and 16 weeks
Change from baseline in high-density lipoprotein cholesterol concentration
Time frame: Baseline and 16 weeks
Change from baseline in low-density lipoprotein cholesterol concentration
Time frame: Baseline and 16 weeks
Change from baseline in triglyceride concentration
Time frame: Baseline and 16 weeks
Change from baseline in resting metabolic rate
Time frame: Baseline and 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- 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.
Ellen C de Freitas, Doctor principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Concurrent Exercise Training and Taurine in people with Obesity (BMI>30), run by University of Sao Paulo at 1 site in Brazil.
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 5 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 28 Jul 2026. 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 Brazil. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Intramuscular Fat Fraction Assessed by Magnetic Resonance Imaging (Dixon Technique) (time frame: Baseline and 16 weeks). The study lists 4 primary outcomes in all. 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 28 Jul 2026.