Plasma Taurine in Older Women With Obesity: Impact of Metabolic Phenotype and Combined Exercise (non applicable)

July 16, 2026 updated by: Ellen Cristini de Freitas, University of Sao Paulo

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Metabolically Healthy Obesity (MHO)
Women with metabolically healthy obesity who participate in regular exercise. Participants will undergo the study assessments for comparison with the other obesity phenotype.
Behavioral: Physical Training of 16 weeks
Combined physical Training during 16 weeks
Other: Metabolically Unhealthy Obesity (MUO)
Women with metabolically unhealthy obesity who participate in regular exercise. Participants will undergo the study assessments for comparison with the other obesity phenotype.
Behavioral: Physical Training of 16 weeks
Combined physical Training during 16 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Plasma taurine concentrations (µmol/L).
Time Frame: 16 weeks
It will be analyzed by high-performance liquid chromatography.
16 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Systolic and diastolic blood pressure (mmHg)
Time Frame: 16 weeks
Using sphygmomanometer
16 weeks
Waist and hip circumferences (cm)
Time Frame: 16 weeks
non-stretch anthropometric tape
16 weeks
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
16 Weeks
Total and regional body fat percentage (%)
Time Frame: 16 weeks
Dual-energy X-ray Absorptiometry
16 weeks
Visceral fat (kg)
Time Frame: 16 weeks
Dual-energy X-ray Absorptiometry
16 weeks
Body mass (kg)
Time Frame: 16 weeks
Dual-energy X-ray Absorptiometry
16 weeks
Body mass index, BMI (kg/m²).
Time Frame: 16 weeks
Using body mass and height measurements
16 weeks
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).
16 weeks
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 (%)
16 weeks
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.
16 weeks
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-].
16 weeks
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).
16 weeks
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).
16 weeks
Food intake - frequency
Time Frame: 16 weeks
Application of Food Frequency Questionnaire, QFA-NOVA for each food group (g/group).
16 weeks
Strength test - leg press
Time Frame: 16 weeks
Strength test - leg press - maximum repetitions pre and post intervention
16 weeks
Strength test - bench press
Time Frame: 16 weeks
Strength test using bench press, pre and post intervention
16 weeks
Funtional capacity: chair sit-to-stand
Time Frame: 16 weeks
Funtional capacity evaluation pre and post intervention
16 weeks
handgrip strength
Time Frame: 16 weeks
handgrip strength using manual dinamometer
16 weeks
funtional capacity: elbow flexion and extension
Time Frame: 16 weeks
funtional capacity: elbow flexion and extension using a dumpbell
16 weeks
Funtional capacity: 6-minute walk test
Time Frame: 16 weeks
6-minute walk test using an 30-meter course with markings every 3 meters.
16 weeks
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).
16 weeks
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).
16 weeks
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).
16 weeks
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).
16 weeks
Glycemic profile - C-peptide
Time Frame: 16 weeks
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)
Time Frame: 16 weeks
Using RT-qPCR pre and post-intervention.
16 weeks
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
16 weeks
Micronutrients (mg/dL)
Time Frame: 16 weeks
Blood Zinc, selenium, and magnesium (mg/dL) using spectrophotometry pre and post intervention
16 weeks
Antioxidant enzymes - Superoxide dismutase
Time Frame: 16 weeks
Superoxide Dismutase (SOD) Assay Kit Pre and post intervention (U/mg)
16 weeks
Antioxidants enzymes - Catalase (CAT)
Time Frame: 16 weeks
Catalase Assay Kit Pre and post intervention (U/mg)
16 weeks
Antioxidants enzymes: Glutationa-peroxidase GPx (U/mg)
Time Frame: 16 weeks
Glutathione Peroxidase Assay Kit Pre and post intervention
16 weeks
Oxidative stress markers - Malondialdehyde (nmol/mL).
Time Frame: 16 weeks
TBARS (Thiobarbituric Acid Reactive Substances) assay pre and post intervention
16 weeks
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.
16 weeks
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
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Taurine_Obesity_Phenotypes
  • 2025/17801-3 (Other Identifier: São Paulo Research Foundation (FAPESP))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings