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NCT Number: NCT04646512

Taurine Supplementation and Exercise on Irisin Levels in Obesity

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.

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Key information

Conditions

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

Age range

25 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gabriela Batitucci

Ribeirão Preto, São Paulo, Brazil

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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.

Treatment and study plan

Taurine group and exercise and placebo group and exercise

Dietary Supplement

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

Physical training with Deep Water Running

Other

There will be a physical training for eight weeks.

Primary outcomes

  1. Changes body weight

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

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

  2. Changes body composition

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

    The body composition was evaluated through deuterium oxide

  3. Changes indirect calorimetry

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

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

  4. Changes in total cholesterol and lipid fractions

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

    Collected in EDTA tubes, were centrifuged.

  5. Changes in plasma taurine concentration

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

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

  6. Changes in plasma irisin concentration

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

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

  7. Changes Food intake

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

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

  8. Changes in determination of lactate

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

    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.

  9. Changes Physical Performance

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

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

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

Effects of Taurine Supplementation Associated With High Intensity Physical Training on Irisin Levels, Energy Expenditure and Body Composition of Obese Women

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Nov 30, 2020
Registry last updated
Nov 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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