Taurine Supplementation Associated or Not With Exercise: Effect on Browning of White Adipose Tissue in Elderly Women With Sarcopenic Obesity

November 28, 2023 updated by: Ellen Cristini de Freitas, University of Sao Paulo
The aging process is followed by metabolic and body composition changes, increasing the risk of obesity and sarcopenia. The coexistence of these conditions acts synergistically on each other and is known as sarcopenic obesity. Beige adipose tissue is a tissue type that emerges from subcutaneous white adipose tissue (WAT), altering its phenotype to resemble the thermogenic functions of brown adipose tissue (BAT) in response to beta-adrenergic stimuli. Some in vitro and animal studies suggest that taurine supplementation and physical exercise are effective interventions in stimulating the aforementioned tissue, promoting what is known as WAT darkening, improving energy metabolism and showing benefits on the maintenance of muscle mass via stimulation of the coactivating protein PGC1α. These investigations are scarce in humans and could help health professionals in the adjuvant treatment of sarcopenic obesity. Therefore, the aim of the present study is to analyze the effects of taurine supplementation associated or not with physical exercise on the darkening of the WAT in sarcopenic obese elderly women.

Study Overview

Detailed Description

The aging process is followed by metabolic and body composition changes, increasing the risk of obesity and sarcopenia. The coexistence of these conditions acts synergistically on each other and is known as sarcopenic obesity. Beige adipose tissue is a tissue type that emerges from subcutaneous white adipose tissue (WAT), altering its phenotype to resemble the thermogenic functions of brown adipose tissue (BAT) in response to beta-adrenergic stimuli. Some in vitro and animal studies suggest that taurine supplementation and physical exercise are effective interventions in stimulating the aforementioned tissue, promoting what is known as WAT darkening, improving energy metabolism and showing benefits on the maintenance of muscle mass via stimulation of the coactivating protein PGC1α. These investigations are scarce in humans and could help health professionals in the adjuvant treatment of sarcopenic obesity. Therefore, the aim of the present study is to analyze the effects of taurine supplementation associated or not with physical exercise on the darkening of the WAT in sarcopenic obese elderly women. Volunteers with low appendicular lean mass (<15 kg) and body mass index (BMI) between 30 and 40 kg/m² will be recruited. These will be subdivided into 4 groups: control group (Cont), taurine (Tau), exercise (Exe) and exercise and taurine (Exe +Tau) and the duration of the intervention for all groups will be 16 weeks. Data related to anthropometry, body composition, biochemical tests, and food intake will be collected. To evaluate the effects on the darkening, a biopsy of the abdominal subcutaneous white adipose tissue will be performed to analyze protein, lipidomic and genetic parameters of this tissue pre and post intervention. Data will be analyzed by Analysis of Variance (ANOVA) or Kruskal-Wallis test depending on the normality of the data that will be tested by Shapiro-Wilk. A significance level for p <0.05 will be admitted. All analyzes will be performed in SPSS version 20 software.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • 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 Locations

    • Sao Paulo
      • Ribeirao Preto, Sao Paulo, Brazil, 14040-907
        • Escola de Educação Física e Esporte de Ribeirão Preto

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

Ages Eligible for Study

60 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • BMI between 30 and 40kg/m²;
  • Appendicular lean mass below 15 kg;
  • Dynamometry below the cutoff point adjusted for sex and BMI (less than or equal to 21kg);
  • "Sit and stand" test below the cut-off point adjusted for the age group, considering the number of repetitions in 30 seconds;
  • Present medical certificate to perform physical exercise

Exclusion Criteria:

  • alcoholics
  • smokers
  • diseases that prevents the practice of physical activity
  • medical impediment to the practice of physical exercise throughout the study
  • infectious diseases
  • coronary diseases
  • chronic kidney diseases
  • undergoing nutritional monitoring or weight loss treatment
  • score ≤13 for cognitive screening on the Mini-Mental State Examination (MMSE)

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Taurine and Exercise (Tau+Exe)
Individuals who will receive 3g of taurine supplementation combined with physical training in the period of 16 weeks
Participants will receive 3g of taurine to be supplemented in the morning in single-dose capsules. The intervention will last 16 weeks.
Participants will perform a multicomponent type workout that explores strength, aerobic and balance capacities with load progression every 15 days. The sessions will last 60 minutes each, being held three times a week with a day of rest in between. The intervention will last 16 weeks
Experimental: Taurine (Tau)
Individuals who will receive 3g of taurine supplementation
Participants will receive 3g of taurine to be supplemented in the morning in single-dose capsules. The intervention will last 16 weeks.
Experimental: Exercise (Exe)
Individuals who will perform a physical training and receive a placebo supplementation in the period of 16 weeks
Participants will perform a multicomponent type workout that explores strength, aerobic and balance capacities with load progression every 15 days. The sessions will last 60 minutes each, being held three times a week with a day of rest in between. The intervention will last 16 weeks
Placebo Comparator: Placebo (Cont)
Individuals who will receive a placebo supplementation in the period of 16 weeks
The participants will receive a supplementation capsule containing placebo in the morning in single-dose capsules. The intervention will last 16 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Browning of white adipose tissue
Time Frame: 16 weeks
Changes in the gene and protein expression on the subcutaneous white adipose tissue
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Indirect calorimetry assessment
Time Frame: 16 weeks
Changes in resting metabolic rate (RMR) evaluated pre and post intervention by indirect calorimetry.
16 weeks
Changes in metabolic parameters - fasting blood glucose
Time Frame: 16 weeks
Changes in fasting blood glucose samples in pre and post intervention
16 weeks
Changes in metabolic parameters - lipid profile
Time Frame: 16 weeks
Changes in lipid profile (total cholesterol, HDL-c, LDL-c, triglycerides)samples in pre and post intervention
16 weeks
Changes in metabolic parameters - insulin sensitivity
Time Frame: 16 weeks
Changes in insulin sensitivity samples in pre and post intervention
16 weeks
Body composition changes
Time Frame: 16 weeks
Changes in fat-free mass and fat mass evaluated pre and post intervention by iDEXA
16 weeks
Improvement of physical performance
Time Frame: 16 weeks
Improvement of physical performance evaluated by the 6-minute walk test, elbow flexion, sit and stand test and hand grip test
16 weeks
Changes in inflamatory markers
Time Frame: 16 weeks
Evaluate the inflamatory markers PCR, IL-1β, IL-6, IL-10, IL-15, IFNy, MCP1, TNF-α, NFκβ, JNK1, PTP1B, iNOS
16 weeks
Changes in subcutaneous white adipose tissue (sWAT) morphology
Time Frame: 16 weeks
Evaluate the changes in the white adipose tissue morphology by the histological analysis
16 weeks
Changes in Lipidomic profile of sWAT
Time Frame: 16 weeks
Evaluate the fatty acids profile in the sWAT
16 weeks
Changes in plasma taurine
Time Frame: 16 weeks
Evaluate the changes in the plasma taurine pre and post intervention
16 weeks
Changes in plasma irisin
Time Frame: 16 weeks
Evaluate the changes in plasma irisin pre and post intervention
16 weeks

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Ellen C de Freitas, PhD, University of São Paulo, School of Physical Education and Sports of Ribeirão Preto Ph.D. +55 16 3602-0345 ellenfreitas@usp.br

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 (Actual)

February 27, 2023

Primary Completion (Actual)

September 26, 2023

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

June 8, 2022

First Submitted That Met QC Criteria

June 8, 2022

First Posted (Actual)

June 10, 2022

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Taurine_exercise_browning

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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