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| ID | Type | Description | Link |
|---|---|---|---|
| 2025/17801-3 | Other Identifier | São Paulo Research Foundation (FAPESP) |
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Population aging has been accompanied by a rise in obesity and other chronic diseases, increasing cardiovascular risk particularly among women, who exhibit a higher prevalence in older age groups compared to men. Aging and obesity share pathophysiological mechanisms, such as chronic inflammation and oxidative stress. However, distinct obesity phenotypes exist, such as metabolically healthy obesity (MHO) and metabolically unhealthy obesity (MUO). Consequently, therapeutic interventions involving nutritional strategies and physical training are highly relevant, especially for older women. Taurine, a sulfur-containing amino acid, plays a role in modulating oxidative stress, inflammation, osmoregulation, and mitochondrial function. Rationale: Plasma taurine concentrations are lower in women with obesity compared to healthy individuals. However, studies investigating these concentrations across different phenotypes-particularly in older women, a group susceptible to functional and metabolic changes-remain limited. Understanding these variations could clarify taurine's role in the pathophysiology of obesity and aging and inform personalized therapeutic strategies. Combined physical training stands out as an effective strategy for modulating inflammatory, oxidative, and metabolic pathways, in addition to improving psychosocial aspects. Given that taurine levels can be influenced by these pathways, investigating the taurine response to physical training across different metabolic phenotypes may contribute to developing low-cost interventions aimed at improving the quality of life for older women with obesity.
This study aims to investigate differences in plasma taurine concentrations between older women with MHO and MUO, and to evaluate the response of taurine-as well as metabolic, inflammatory, oxidative, and cellular markers-to a 16-week combined physical training intervention. The study will involve 36 older women with obesity, classified as having either MHO or MUO. In Stage 1, nutritional and anthropometric assessments will be conducted, along with the collection of biological samples for biochemical and molecular analyses. In Stage 2, participants will undergo a combined physical exercise intervention for 16 weeks; nutritional, anthropometric, physical performance, and functional assessments will be performed, as well as the collection of biological samples for pre- and post-intervention biochemical and molecular analyses. Stage 3 will consist of integrated data analysis to identify variables predicting plasma taurine concentrations at baseline and post-intervention. Data analysis method: Data will be analyzed using Student's t-tests or Mann-Whitney tests (Stage 1), ANOVA or Kruskal-Wallis tests (Stage 2), Pearson or Spearman correlations (Stages 1 and 2), and linear regression models (Stage 3), using SPSS software (α=5%). Expected results: It is expected that older women with OMS will exhibit higher baseline taurine concentrations and that combined physical training will increase these concentrations in both groups-with a more pronounced effect in the OMS phenotype-in addition to promoting cardiometabolic, functional, inflammatory, oxidative, and psychosocial benefits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metabolically Healthy Obesity (MHO) | Other | Women with metabolically healthy obesity who participate in regular exercise. Participants will undergo the study assessments for comparison with the other obesity phenotype. |
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| Metabolically Unhealthy Obesity (MUO) | Other | Women with metabolically unhealthy obesity who participate in regular exercise. Participants will undergo the study assessments for comparison with the other obesity phenotype. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical Training of 16 weeks | Behavioral | Combined physical Training during 16 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Plasma taurine concentrations (µmol/L). | It will be analyzed by high-performance liquid chromatography. | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic and diastolic blood pressure (mmHg) | Using sphygmomanometer | 16 weeks |
| Waist and hip circumferences (cm) | non-stretch anthropometric tape |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ellen Cristini de Freitas, Dr | Contact | +551633150345 | ellenfreitas@usp.br |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D000067329 | Obesity, Metabolically Benign |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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A study comprising three sequential and interdependent stages will be conducted; the first stage will employ a cross-sectional, descriptive-analytical design and adhere to the "Strengthening the Reporting of Observational Studies in Epidemiology" (STROBE) recommendations. The sample will consist of 36 elderly women with obesity, allocated into two groups based on the OMS and OMNS classifications (18 elderly women per group). The second stage will be a 16-week clinical trial following the CONSORT checklist (HOPEWELL et al., 2025). In this stage, both groups (OMS and OMNS) will undergo a physical training intervention over the course of 16 weeks. Stage 3 will consist of an integrated analysis of data obtained in stages 1 and 2 to examine factors explaining potential variability in plasma taurine concentrations. No new data collection procedures will be performed during this stage, as all necessary data will be derived from previously conducted assessments.
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| 16 weeks |
| Appendicular lean soft tissue (kg). | Using Dual-energy X-ray Absorptiometry (DXA), often referred to as iDXA, is a low-dose X-ray technology that measures bone mineral density (BMD) and body composition | 16 Weeks |
| Total and regional body fat percentage (%) | Dual-energy X-ray Absorptiometry | 16 weeks |
| Visceral fat (kg) | Dual-energy X-ray Absorptiometry | 16 weeks |
| Body mass (kg) | Dual-energy X-ray Absorptiometry | 16 weeks |
| Body mass index, BMI (kg/m²). | Using body mass and height measurements | 16 weeks |
| Inflammatory and antiinflamatory profile | Changes in serum levels of cytokines will be evaluated with MILLIPLEX® Kit. Pro- inflammatory citokines: IL-1β, MCP-1,TNF-α, IL-6, IL-13 (pg/mL), leptina e PCR-us (mg/dL), IL-10 (pg/mL) e adiponectina (mg/dL). | 16 weeks |
| Food Intake | A food record of three non-consecutive days: two days of the week and one day in the weekend. This evaluation will last 16 weeks. Will be evaluated with Dietwin® software (São Paulo, Brazil): The macronutrients, micronutrients and fiber in quilocalories and percentage (%) | 16 weeks |
| Aerobic performance - VO2 | Physical tests performed pre and post- intervention to assess aerobic physical fitness by incremental test in cycle ergometer. The test aim to evaluate VO2peak in ml.kg-1.min-1. | 16 weeks |
| Aerobic performance - LacAnTh | Physical tests performed pre and post- intervention to assess aerobic physical fitness by incremental test in cycle ergometer. The test aim to evaluate: Anaerobic threshold (AT) using lactate concentration [lac-]. | 16 weeks |
| Aerobic performance - IAnTh | Physical tests performed pre and post- intervention to assess aerobic physical fitness by incremental test in cycle ergometer. The test aim to evaluate: Anaerobic threshold (AT) using intensity in Watts (W). | 16 weeks |
| Aerobic performance - HRAnTh | Physical tests performed pre and post- intervention to assess aerobic physical fitness by incremental test in cycle ergometer. The test aim to evaluate: Anaerobic threshold (AT) using heart rate (HR). | 16 weeks |
| Food intake - frequency | Application of Food Frequency Questionnaire, QFA-NOVA for each food group (g/group). | 16 weeks |
| Strength test - leg press | Strength test - leg press - maximum repetitions pre and post intervention | 16 weeks |
| Strength test - bench press | Strength test using bench press, pre and post intervention | 16 weeks |
| Funtional capacity: chair sit-to-stand | Funtional capacity evaluation pre and post intervention | 16 weeks |
| handgrip strength | handgrip strength using manual dinamometer | 16 weeks |
| funtional capacity: elbow flexion and extension | funtional capacity: elbow flexion and extension using a dumpbell | 16 weeks |
| Funtional capacity: 6-minute walk test | 6-minute walk test using an 30-meter course with markings every 3 meters. | 16 weeks |
| Glycemic profile | Quantified by Total Liquiform Cholesterol Kit, HDL Cholesterol Kit and Liquiform Triglycerides Kit, from Labtest diagnóstica®, using an enzymatic system and absorbance spectrophotometer: Changes in blood glucose (mg/dL). | 16 weeks |
| Lipid profile - Total cholesterol | Quantified by Total Liquiform Cholesterol Kit, HDL Cholesterol Kit and Liquiform Triglycerides Kit, from Labtest diagnóstica®, using an enzymatic system and absorbance spectrophotometer: Changes in total cholesterol (mg/dL). | 16 weeks |
| Lipid profile: HDL-cholesterol and LDL-cholesterol (mg/dL). | Quantified by Total Liquiform Cholesterol Kit, HDL Cholesterol Kit and Liquiform Triglycerides Kit, from Labtest diagnóstica®, using an enzymatic system and absorbance spectrophotometer: Changes in HDL-cholesterol and LDL-cholesterol (mg/dL). | 16 weeks |
| Lipid profile: triglycerides (mg/dL). | Quantified by Total Liquiform Cholesterol Kit, HDL Cholesterol Kit and Liquiform Triglycerides Kit, from Labtest diagnóstica®, using an enzymatic system and absorbance spectrophotometer: Changes in triglycerides (mg/dL). | 16 weeks |
| Glycemic profile - C-peptide | C-peptide pre and post intervention using Chemiluminescence (CLIA - Chemiluminescent Immunoassay) | 16 weeks |
| Expression of inflammatory and anti-inflammatory genes in peripheral blood mononuclear cells (PBMCs) | Using RT-qPCR pre and post-intervention. | 16 weeks |
| Expression of genes related to telomere length: TRF1, TRF2, RAP1, TPP1, POT1, TIN2, and hTERT. | Using RT-qPCR pre and post intervention | 16 weeks |
| Micronutrients (mg/dL) | Blood Zinc, selenium, and magnesium (mg/dL) using spectrophotometry pre and post intervention | 16 weeks |
| Antioxidant enzymes - Superoxide dismutase | Superoxide Dismutase (SOD) Assay Kit Pre and post intervention (U/mg) | 16 weeks |
| Antioxidants enzymes - Catalase (CAT) | Catalase Assay Kit Pre and post intervention (U/mg) | 16 weeks |
| Antioxidants enzymes: Glutationa-peroxidase GPx (U/mg) | Glutathione Peroxidase Assay Kit Pre and post intervention | 16 weeks |
| Oxidative stress markers - Malondialdehyde (nmol/mL). | TBARS (Thiobarbituric Acid Reactive Substances) assay pre and post intervention | 16 weeks |
| Relative telomere length | The assay will be based on quantifying the ratio between the amplification of telomeric sequences (T) and a single-copy gene (S), enabling the estimation of relative telomere length in the biological samples. | 16 weeks |
| Nitrogen balance | Urinary nitrogen excretion (g) will be determined using the Labtest Diagnóstica kit (UREA CE), estimating urinary nitrogen excretion based on urea levels. Daily protein intake will also be used, pre and post intervention | 16 weeks |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |