Taurine Supplementation and Exercise on Irisin Levels in Obesity

Sponsor

University of Sao Paulo (Other)

Overall Status

Completed

CT.gov ID

NCT04646512

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Dietary Supplement: Taurine group and exercise and placebo group and exercise Other: Physical training with Deep Water Running	N/A

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

31 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

double blind trialdouble blind trial

Masking:

Double (Participant, Investigator)

Masking Description:

Intervention with taurine and / or placebo supplementation and physical training

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Feb 1, 2016

Actual Primary Completion Date :

May 1, 2016

Actual Study Completion Date :

Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Taurine group and exercise Intervention with taurine supplementation and physical training.	Dietary Supplement: Taurine group and exercise and placebo group and exercise Both groups supplemented with taurine and / or placebo will perform physical training. Other: Physical training with Deep Water Running There will be a physical training for eight weeks.
Placebo Comparator: Placebo group and exercise Intervention with placebo supplementation and physical training.	Dietary Supplement: Taurine group and exercise and placebo group and exercise Both groups supplemented with taurine and / or placebo will perform physical training. Other: Physical training with Deep Water Running There will be a physical training for eight weeks.

Arm

Intervention/Treatment

Active Comparator: Taurine group and exercise

Intervention with taurine supplementation and physical training.

Dietary Supplement: Taurine group and exercise and placebo group and exercise

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

Other: Physical training with Deep Water Running

There will be a physical training for eight weeks.

Placebo Comparator: Placebo group and exercise

Intervention with placebo supplementation and physical training.

Dietary Supplement: Taurine group and exercise and placebo group and exercise

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

Other: Physical training with Deep Water Running

There will be a physical training for eight weeks.

Outcome Measures

Primary Outcome Measures

Changes body weight [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
Changes body composition [Two times: (1) First day and (2) 10 weeks after assessments, adaptation and intervention]
The body composition was evaluated through deuterium oxide
Changes indirect calorimetry [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)
Changes in total cholesterol and lipid fractions [Two times: (1) First day and (2) 10 weeks after assessments, adaptation and intervention]
Collected in EDTA tubes, were centrifuged.
Changes in plasma taurine concentration [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).
Changes in plasma irisin concentration [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.
Changes Food intake [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.
Changes in determination of lactate [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.
Changes Physical Performance [Two times: (1) First day and (2) 10 weeks after assessments, adaptation and intervention]
Maximum effort test, according to Wilder, Brennan e Schotte (1993).

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.