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

NCT07711899 | Not Yet Recruiting

• 2 other identifiers: Taurine_Obesity_Phenotypes2025/17801-3
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Plasma taurine concentrations (µmol/L).

  It will be analyzed by high-performance liquid chromatography.

  16 weeks

Secondary Outcomes (34)

• Systolic and diastolic blood pressure (mmHg)

  16 weeks

• Waist and hip circumferences (cm)

  16 weeks

• Appendicular lean soft tissue (kg).

  16 Weeks

• Total and regional body fat percentage (%)

  16 weeks

• Visceral fat (kg)

  16 weeks

Study Arms (2)

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.

Behavioral: Physical Training of 16 weeks

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.

Behavioral: Physical Training of 16 weeks

Interventions

Physical Training of 16 weeks BEHAVIORAL

Combined physical Training during 16 weeks

Metabolically Healthy Obesity (MHO); Metabolically Unhealthy Obesity (MUO)

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

MeSH Terms

Conditions

Obesity; Obesity, Metabolically Benign

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ellen Cristini de Freitas, Dr

CONTACT

+551633150345; ellenfreitas@usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Responsible Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 17, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2030
• Last Updated: July 20, 2026

Record last verified: 2026-07