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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07711899
Acronym
non applicable
Enrollment
36
Registered
2026-07-17
Start date
2026-10-01
Completion date
2030-03-01
Last updated
2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolically Healthy Obesity, Metabolically Unhealty Obese, Obesity (BMI>30)

Keywords

Taurine, Metabolically unhealthy obesity., Metabolically healthy obesity., Physical training, Aging

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALPhysical Training of 16 weeks

Combined physical Training during 16 weeks

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
FEMALE
Age
60 Years to 75 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Plasma taurine concentrations (µmol/L).16 weeksIt will be analyzed by high-performance liquid chromatography.

Secondary

MeasureTime frameDescription
Systolic and diastolic blood pressure (mmHg)16 weeksUsing sphygmomanometer
Waist and hip circumferences (cm)16 weeksnon-stretch anthropometric tape
Appendicular lean soft tissue (kg).16 WeeksUsing 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
Total and regional body fat percentage (%)16 weeksDual-energy X-ray Absorptiometry
Visceral fat (kg)16 weeksDual-energy X-ray Absorptiometry
Body mass (kg)16 weeksDual-energy X-ray Absorptiometry
Body mass index, BMI (kg/m²).16 weeksUsing body mass and height measurements
Inflammatory and antiinflamatory profile16 weeksChanges 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).
Food Intake16 weeksA 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 (%)
Aerobic performance - VO216 weeksPhysical 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.
Aerobic performance - LacAnTh16 weeksPhysical 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 \[lac-\].
Aerobic performance - IAnTh16 weeksPhysical 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).
Aerobic performance - HRAnTh16 weeksPhysical 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).
Food intake - frequency16 weeksApplication of Food Frequency Questionnaire, QFA-NOVA for each food group (g/group).
Strength test - leg press16 weeksStrength test - leg press - maximum repetitions pre and post intervention
Strength test - bench press16 weeksStrength test using bench press, pre and post intervention
Funtional capacity: chair sit-to-stand16 weeksFuntional capacity evaluation pre and post intervention
handgrip strength16 weekshandgrip strength using manual dinamometer
funtional capacity: elbow flexion and extension16 weeksfuntional capacity: elbow flexion and extension using a dumpbell
Funtional capacity: 6-minute walk test16 weeks6-minute walk test using an 30-meter course with markings every 3 meters.
Glycemic profile16 weeksQuantified 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).
Lipid profile - Total cholesterol16 weeksQuantified 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).
Lipid profile: HDL-cholesterol and LDL-cholesterol (mg/dL).16 weeksQuantified 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).
Lipid profile: triglycerides (mg/dL).16 weeksQuantified 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).
Glycemic profile - C-peptide16 weeksC-peptide pre and post intervention using Chemiluminescence (CLIA - Chemiluminescent Immunoassay)
Expression of inflammatory and anti-inflammatory genes in peripheral blood mononuclear cells (PBMCs)16 weeksUsing RT-qPCR pre and post-intervention.
Expression of genes related to telomere length: TRF1, TRF2, RAP1, TPP1, POT1, TIN2, and hTERT.16 weeksUsing RT-qPCR pre and post intervention
Micronutrients (mg/dL)16 weeksBlood Zinc, selenium, and magnesium (mg/dL) using spectrophotometry pre and post intervention
Antioxidant enzymes - Superoxide dismutase16 weeksSuperoxide Dismutase (SOD) Assay Kit Pre and post intervention (U/mg)
Antioxidants enzymes - Catalase (CAT)16 weeksCatalase Assay Kit Pre and post intervention (U/mg)
Antioxidants enzymes: Glutationa-peroxidase GPx (U/mg)16 weeksGlutathione Peroxidase Assay Kit Pre and post intervention
Oxidative stress markers - Malondialdehyde (nmol/mL).16 weeksTBARS (Thiobarbituric Acid Reactive Substances) assay pre and post intervention
Relative telomere length16 weeksThe 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.
Nitrogen balance16 weeksUrinary 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

Contacts

CONTACTEllen Cristini de Freitas, Dr
ellenfreitas@usp.br+551633150345

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 21, 2026