Obesity (BMI>30)
Conditions
Keywords
Obesity, Taurine, Physical Exercise, Intramuscular Fat Infiltration, Transcriptomics, Metabolomics
Brief 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. 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.
Interventions
BEHAVIORALConcurrent Exercise Training
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.
DIETARY_SUPPLEMENTTaurine
Participants will receive 3 grams per day taurine supplementation administered orally in capsules for 16 weeks.
OTHERPlacebo
Participants will receive placebo capsules identical in appearance to taurine capsules.
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants and outcome assessors will be blinded to taurine supplementation allocation. Taurine and placebo capsules will be identical in appearance.
Intervention model description
Randomized clinical trial
Eligibility
Sex/Gender
FEMALE
Age
60 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Intramuscular Fat Fraction Assessed by Magnetic Resonance Imaging (Dixon Technique) | 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 | 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 | 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 | Baseline and 16 weeks | Plasma taurine concentration will be measured before and after the 16-week intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Timed Up and Go test time | Baseline and 16 weeks | Functional mobility will be assessed using the Timed Up and Go test. |
| Change from baseline in handgrip strength | Baseline and 16 weeks | Handgrip strength will be assessed using a hand dynamometer. |
| Change from baseline in chair stand test performance | Baseline and 16 weeks | Lower-body functional performance will be assessed using the Chair Stand Test. |
| Change from baseline in forearm flexion test performance | Baseline and 16 weeks | Upper-body muscular endurance will be assessed using the Forearm Flexion Test. |
| Change from baseline in isokinetic knee extensor peak torque | Baseline and 16 weeks | Peak torque of the knee extensor muscles will be measured using an isokinetic dynamometer. |
| Change from baseline in fat-free mass | Baseline and 16 weeks | Fat-free mass will be assessed by dual-energy X-ray absorptiometry. |
| Change from baseline in fat mass | Baseline and 16 weeks | Fat mass will be assessed by dual-energy X-ray absorptiometry. |
| Change from baseline in fasting blood glucose concentration | Baseline and 16 weeks | Fasting blood glucose concentration will be measured using blood samples collected after an overnight fast. |
| Change from baseline in fasting insulin concentration | Baseline and 16 weeks | Fasting insulin concentration will be measured using blood samples collected after an overnight fast. |
| Change from baseline in total cholesterol concentration | Baseline and 16 weeks | Total cholesterol concentration will be measured using fasting blood samples. |
| Change from baseline in high-density lipoprotein cholesterol concentration | Baseline and 16 weeks | High-density lipoprotein cholesterol concentration will be measured using fasting blood samples. |
| Change from baseline in low-density lipoprotein cholesterol concentration | Baseline and 16 weeks | Low-density lipoprotein cholesterol concentration will be measured using fasting blood samples. |
| Change from baseline in triglyceride concentration | Baseline and 16 weeks | Triglyceride concentration will be measured using fasting blood samples. |
| Change from baseline in resting metabolic rate | Baseline and 16 weeks | Resting metabolic will be assessed by indirect calorimetry after an overnight fast. |
Countries
Brazil
Contacts
PRINCIPAL_INVESTIGATOREllen C de Freitas, Doctor
University of Sao Paulo
Outcome results
None listed