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CompletedNCT04646512Updated Nov 30, 2020

Taurine Supplementation and Exercise on Irisin Levels in Obesity

An interventional study of Taurine group and exercise and placebo group and exercise and Physical training with Deep Water Running in Obesity, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to female participants aged 25 Years to 45 Years. Per ClinicalTrials.gov, last updated 2020-11-30.

Sponsored by University of Sao Paulo · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 4 years 9 months after the study started (first participant enrolled Feb 2016, registered Nov 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
31
Allocation
Randomized
Ages
25 Years to 45 Years
Sex
Female
01

Study summary

Irisin is a myocin secreted by skeletal muscle in stimulus to physical exercise and has been described as a possible therapeutic tool in the fight against obesity by triggering a cascade of signaling that triggers the expression of genes responsible for the increase in energy expenditure and browning of adipose tissue white cells by activating thermogenesis promoter mitochondrial proteins. Although the science is engaged in the search for evidences about the actions of the irisin, the physical exercise involved and the improvement in the levels of obesity, many mechanisms are still unknown. Since taurine by means of irisin-like pathways also increases energy expenditure, it is believed that taurine supplementation associated with high intensity aerobic physical exercise can optimize the effects of irisin, increasing energy expenditure and improving body composition in obesity.

Read the detailed description

Introduction: Irisin is a myocin secreted by skeletal muscle when stimulated by physical exercise that promotes increased thermogenesis (browning effect). Similarly, taurine is also associated with modulations of energy metabolism with promising actions in the control of metabolic disorders. Thus, it is believed that chronic taurine supplementation associated with physical training can optimize irisin concentrations after exercise.

Objective: Evaluate the effects of taurine supplementation associated with interval aerobic training on plasma irisin concentrations, energy expenditure, body composition and physical fitness in obese women. Methods: Twenty-two women aged 25 to 45 years, sedentary, with grade I obesity (BMI ≥30-35 kg / m²) and without comorbidities will be recruited for the study. The subjects will be submited to a high intensity interval aerobic training for 8 weeks, being 3 times by week, for 50 minutes, associated to the supplementation with 3g of taurine or placebo.

Methods: Assessment of dietary intake, Resting Energy Expenditure (GER) by indirect calorimetry, body composition by deuterium oxide, anthropometric measurements, HPLC plasma analysis of taurine, multiplex irisin and physical fitness variables will be performed pre and post intervention. The results will be expressed as mean and standard deviation and the ANOVA test two way repeated measures mixed model will be applied, with post hoc Sidak, to verify differences and statistical interactions (p \<0.05).

02

Conditions studied

  • Obesity

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Keywords

  • Obesity
  • Exercise
  • Irisin
  • Taurine
  • Energy Expenditure
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,695 are open to participants now.

This study's enrollment of 31 is below the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • This study included women with obesity grade I (BMI ≥30 - ≤35Kg/m²), sedentary, with no associated comorbidity, convenience sample.

Exclusion criteria

Exclusion Criteria:

  • Women classified as overweight, obesity grade II and grade III (morbid), who present comorbidities associated with obesity (pre-diabetes, diabetes, hypertension, dyslipidemia, cardiovascular diseases and diseases of bone metabolism); smokers; who use hormones, sports supplements and / or weight loss medications. Perform some type of nutritional monitoring followed by diet or weight loss guidelines and that have medical impediment to the practice of physical exercise.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
31 participants (actual)

Study arms

  • Active comparator
    Taurine group and exercise

    Intervention with taurine supplementation and physical training.

    Dietary Supplement: Taurine group and exercise and placebo group and exercise · Other: Physical training with Deep Water Running

  • Placebo comparator
    Placebo group and exercise

    Intervention with placebo supplementation and physical training.

    Dietary Supplement: Taurine group and exercise and placebo group and exercise · Other: Physical training with Deep Water Running

Interventions

  • Dietary supplementTaurine group and exercise and placebo group and exercise

    Both groups supplemented with taurine and / or placebo will perform physical training.

  • OtherPhysical training with Deep Water Running

    There will be a physical training for eight weeks.

06

What researchers measure

Primary outcomes

  1. Changes body weight

    The body weight was measured by digital balance before and after the intervention

    Time frame: Two times: (1) First day and (2) 10 weeks after assessments, adaptation and intervention

  2. Changes body composition

    The body composition was evaluated through deuterium oxide

    Time frame: Two times: (1) First day and (2) 10 weeks after assessments, adaptation and intervention

  3. Changes indirect calorimetry

    With a gas analyzer (indirect calorimeter), we evaluated the metabolic rate and rest (REE) and oxidation of substrates (lipids and carbohydrates)

    Time frame: Two times: (1) First day and (2) 10 weeks after assessments, adaptation and intervention

  4. Changes in total cholesterol and lipid fractions

    Collected in EDTA tubes, were centrifuged.

    Time frame: Two times: (1) First day and (2) 10 weeks after assessments, adaptation and intervention

  5. Changes in plasma taurine concentration

    Collected in EDTA tubes, were centrifuged and the plasma taurine concentration was evaluated using HPLC (high performance liquid chromatography).

    Time frame: Two times: (1) First day and (2) 10 weeks after assessments, adaptation and intervention

  6. Changes in plasma irisin concentration

    Collected in EDTA tubes, were centrifuged and the plasma irisin concentration was evaluated using Multiplex - Kit Human Myokine Magnetic Bead Panel.

    Time frame: Two times: (1) First day and (2) 10 weeks after assessments, adaptation and intervention

  7. Changes Food intake

    Food registry of 3 days. The quantification of the daily intake of nutrients will still be made using sofware.

    Time frame: Two times: (1) First day and (2) 10 weeks after assessments, adaptation and intervention

  8. Changes in determination of lactate

    Blood samples were collected by manual puncture of the earlobe in previously calibrated and heparinized capillary tubes, stored in eppendorf with sodium fluoride. Analyzed by electrochemical lactate analyser.

    Time frame: Two times: (1) First day and (2) 10 weeks after assessments, adaptation and intervention

  9. Changes Physical Performance

    Maximum effort test, according to Wilder, Brennan e Schotte (1993).

    Time frame: Two times: (1) First day and (2) 10 weeks after assessments, adaptation and intervention

07

Study locations

1 site
  • Gabriela Batitucci
    Ribeirão Preto, SP, Brazil
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04646512
Lead sponsor
University of Sao Paulo
Responsible party
Ellen Cristini de Freitas (Principal Investigator, University of Sao Paulo) — Principal investigator
First posted
Nov 30, 2020
Start date
Feb 1, 2016
Primary completion
May 1, 2016
Completion
Aug 1, 2016
Last update
Nov 30, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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