Exercise and Taurine Supplementation on Intramuscular Fat in Older Women With Obesity

NCT07730255 | Active Not Recruiting DMC

• 1 other identifier: CAAE: 93008225.6.0000.5659
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized clinical trial aims to investigate the effects of multicomponent concurrent exercise training associated or not with taurine supplementation on intramuscular fat infiltration, physical performance, transcriptomic profile, and metabolomic profile in older women with obesity. Forty women aged 60 to 75 years with obesity will be randomized into four groups: control, exercise, taurine, and exercise plus taurine. The intervention will last 16 weeks. Outcomes include magnetic resonance imaging, body composition, muscle biopsy, blood biomarkers, functional capacity tests, transcriptomic analysis, and metabolomic analysis.

Conditions

Obesity (BMI>30)

Keywords

Obesity; Taurine; Physical Exercise; Intramuscular Fat Infiltration; Transcriptomics; Metabolomics

Outcome Measures

Primary Outcomes (4)

• Change from Baseline in Intramuscular Fat Fraction Assessed by Magnetic Resonance Imaging (Dixon Technique)

  Intramuscular fat fraction assessed by magnetic resonance imaging (MRI) using the Dixon technique, reported as percentage (%) of fat within the muscle tissue. Change is calculated from baseline to Week 16.

  Baseline and 16 weeks

• Change from baseline in skeletal muscle transcriptomic profile

  Skeletal muscle biopsy samples will be analyzed using RNA sequencing to characterize changes in the skeletal muscle transcriptomic profile following the intervention.

  Baseline and 16 weeks

• Change from baseline in plasma metabolomic profile

  Plasma samples will be analyzed using untargeted metabolomic analysis to evaluate changes in the plasma metabolomic profile after 16 weeks of intervention.

  16 weeks

• Change from baseline in plasma taurine concentration

  Plasma taurine concentration will be measured before and after the 16-week intervention.

  Baseline and 16 weeks

Secondary Outcomes (14)

• Change from baseline in Timed Up and Go test time

  Baseline and 16 weeks

• Change from baseline in handgrip strength

  Baseline and 16 weeks

• Change from baseline in chair stand test performance

  Baseline and 16 weeks

• Change from baseline in forearm flexion test performance

  Baseline and 16 weeks

• Change from baseline in isokinetic knee extensor peak torque

  Baseline and 16 weeks

Study Arms (4)

Control group

PLACEBO COMPARATOR

Participants will not receive exercise training or taurine supplementation, only the placebo.

Other: Placebo

Exercise group

EXPERIMENTAL

Participants will undergo supervised concurrent exercise training three times per week for 16 weeks and will receive placebo.

Behavioral: Concurrent Exercise Training; Other: Placebo

Taurine supplementation group

EXPERIMENTAL

Participants will receive 3 grams per day taurine supplementation for 16 weeks.

Dietary Supplement: Taurine

Exercise plus taurine supplementation group

EXPERIMENTAL

Participants will undergo supervised multicomponent concurrent exercise training combined with 3 grams per day taurine supplementation for 16 weeks.

Behavioral: Concurrent Exercise Training; Dietary Supplement: Taurine

Interventions

Concurrent Exercise Training BEHAVIORAL

Participants will perform supervised concurrent exercise training three times per week for 16 weeks. Exercise sessions will include warm-up, resistance exercises, aerobic training, and stretching exercises, according to American College of Sports Medicine (ACSM) recommendations for older adults.

Exercise group; Exercise plus taurine supplementation group

Taurine DIETARY_SUPPLEMENT

Participants will receive 3 grams per day taurine supplementation administered orally in capsules for 16 weeks.

Exercise plus taurine supplementation group; Taurine supplementation group

Placebo OTHER

Participants will receive placebo capsules identical in appearance to taurine capsules.

Control group; Exercise group

Eligibility Criteria

• Age: 60 Years - 75 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female,
• and 75 years of age,
• Body mass lower than 120 kg,
• Be sedentary (not having engaged in physical exercise for at least 3 months), and
• Body Mass Index between 30 and 40 kg/m².

You may not qualify if:

• alcohol consumption,
• smoking,
• infectious and contagious diseases,
• chronic kidney diseases,
• undergoing weight loss treatment, and
• presenting a score ≤13 on cognitive screening using the Mini-Mental State Examination (MMSE).

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Escola de Educação Física e Esporte de Ribeirão Preto, Ribeirão Preto, São Paulo.

Ribeirão Preto, São Paulo, 14040-900, Brazil

Location

MeSH Terms

Conditions

Obesity; Motor Activity

Interventions

Taurine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Ellen C de Freitas, Doctor

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors will be blinded to taurine supplementation allocation. Taurine and placebo capsules will be identical in appearance.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: July 28, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)