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NCT Number: NCT07711899

Plasma Taurine in Older Women With Obesity: Impact of Metabolic Phenotype and Combined Exercise

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women aged 60 to 75 years.
  • Residents of the city or region of Ribeirão Preto, São Paulo, Brazil.
  • Physically inactive for at least 3 months.
  • Body mass index (BMI) ≥ 30 kg/m² (PAHO, 2002).
  • Body fat percentage ≥ 35%, according to obesity diagnostic criteria (Batsis et al., 2016; Rubino et al., 2025).

Classified into one of two obesity phenotypes based on Zembic et al. (2021):

Metabolically Healthy Obesity (MHO/OMS): all of the following criteria must be met:

  • Systolic blood pressure (SBP) < 130 mmHg;
  • Waist-to-hip ratio < 0.95;
  • Fasting blood glucose < 126 mg/dL.

Metabolically Unhealthy Obesity (MUO/OMNS): meets two or fewer of the above criteria.

Exclusion criteria

Clinical conditions

  • Contraindication to physical exercise.
  • Current or previous diagnosis of:
  • Neoplasms;
  • Autoimmune diseases;
  • Hepatic diseases;
  • Coronary diseases;
  • Renal diseases;
  • Neurodegenerative diseases;
  • Infectious diseases.

Previous or ongoing treatments

  • Use of medication for thyroid disorders.
  • Participation in exercise training programs, nutritional counseling, or weight loss treatment within the 3 months preceding the intervention.

Lifestyle habits

  • Current smoking.
  • Alcohol consumption.

For MHO Group:

  • Medication use
  • Hypoglycemic agents
  • Insulin (Bell, Kivimäki, & Hamer, 2014).
  • Protocol adherence *Attendance at less than 80% of the training sessions (De Carvalho et al., 2021).

Treatment and study plan

Physical Training of 16 weeks

Behavioral

Combined physical Training during 16 weeks

Primary outcomes

  1. Plasma taurine concentrations (µmol/L).

    Time frame: 16 weeks

    It will be analyzed by high-performance liquid chromatography.

Secondary outcomes

  1. Systolic and diastolic blood pressure (mmHg)

    Time frame: 16 weeks

    Using sphygmomanometer

  2. Waist and hip circumferences (cm)

    Time frame: 16 weeks

    non-stretch anthropometric tape

  3. Appendicular lean soft tissue (kg).

    Time frame: 16 Weeks

    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

  4. Total and regional body fat percentage (%)

    Time frame: 16 weeks

    Dual-energy X-ray Absorptiometry

  5. Visceral fat (kg)

    Time frame: 16 weeks

    Dual-energy X-ray Absorptiometry

  6. Body mass (kg)

    Time frame: 16 weeks

    Dual-energy X-ray Absorptiometry

  7. Body mass index, BMI (kg/m²).

    Time frame: 16 weeks

    Using body mass and height measurements

  8. Inflammatory and antiinflamatory profile

    Time frame: 16 weeks

    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).

  9. Food Intake

    Time frame: 16 weeks

    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 (%)

  10. Aerobic performance - VO2

    Time frame: 16 weeks

    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.

  11. Aerobic performance - LacAnTh

    Time frame: 16 weeks

    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-].

  12. Aerobic performance - IAnTh

    Time frame: 16 weeks

    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).

  13. Aerobic performance - HRAnTh

    Time frame: 16 weeks

    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).

  14. Food intake - frequency

    Time frame: 16 weeks

    Application of Food Frequency Questionnaire, QFA-NOVA for each food group (g/group).

  15. Strength test - leg press

    Time frame: 16 weeks

    Strength test - leg press - maximum repetitions pre and post intervention

  16. Strength test - bench press

    Time frame: 16 weeks

    Strength test using bench press, pre and post intervention

  17. Funtional capacity: chair sit-to-stand

    Time frame: 16 weeks

    Funtional capacity evaluation pre and post intervention

  18. handgrip strength

    Time frame: 16 weeks

    handgrip strength using manual dinamometer

  19. funtional capacity: elbow flexion and extension

    Time frame: 16 weeks

    funtional capacity: elbow flexion and extension using a dumpbell

  20. Funtional capacity: 6-minute walk test

    Time frame: 16 weeks

    6-minute walk test using an 30-meter course with markings every 3 meters.

  21. Glycemic profile

    Time frame: 16 weeks

    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).

  22. Lipid profile - Total cholesterol

    Time frame: 16 weeks

    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).

  23. Lipid profile: HDL-cholesterol and LDL-cholesterol (mg/dL).

    Time frame: 16 weeks

    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).

  24. Lipid profile: triglycerides (mg/dL).

    Time frame: 16 weeks

    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).

  25. Glycemic profile - C-peptide

    Time frame: 16 weeks

    C-peptide pre and post intervention using Chemiluminescence (CLIA - Chemiluminescent Immunoassay)

  26. Expression of inflammatory and anti-inflammatory genes in peripheral blood mononuclear cells (PBMCs)

    Time frame: 16 weeks

    Using RT-qPCR pre and post-intervention.

  27. Expression of genes related to telomere length: TRF1, TRF2, RAP1, TPP1, POT1, TIN2, and hTERT.

    Time frame: 16 weeks

    Using RT-qPCR pre and post intervention

  28. Micronutrients (mg/dL)

    Time frame: 16 weeks

    Blood Zinc, selenium, and magnesium (mg/dL) using spectrophotometry pre and post intervention

  29. Antioxidant enzymes - Superoxide dismutase

    Time frame: 16 weeks

    Superoxide Dismutase (SOD) Assay Kit Pre and post intervention (U/mg)

  30. Antioxidants enzymes - Catalase (CAT)

    Time frame: 16 weeks

    Catalase Assay Kit Pre and post intervention (U/mg)

  31. Antioxidants enzymes: Glutationa-peroxidase GPx (U/mg)

    Time frame: 16 weeks

    Glutathione Peroxidase Assay Kit Pre and post intervention

  32. Oxidative stress markers - Malondialdehyde (nmol/mL).

    Time frame: 16 weeks

    TBARS (Thiobarbituric Acid Reactive Substances) assay pre and post intervention

  33. Relative telomere length

    Time frame: 16 weeks

    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.

  34. Nitrogen balance

    Time frame: 16 weeks

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Ellen Cristini de Freitas, Dr

CONTACT

[email protected]

+551633150345

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

Plasma Taurine Concentrations in Older Women With Obesity: The Influence of Metabolic Phenotype and Combined Exercise Training

Acronym: non applicable

Important dates

Study start
2026
Primary completion
2027
Study completion
2030
First posted
Jul 17, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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