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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04646512
Other study ID # 51921115500005426
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2016
Est. completion date August 1, 2016

Study information

Verified date November 2020
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date August 1, 2016
Est. primary completion date May 1, 2016
Accepts healthy volunteers No
Gender Female
Age group 25 Years to 45 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Brazil Gabriela Batitucci Ribeirão Preto SP

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes body weight The body weight was measured by digital balance before and after the intervention Two times: (1) First day and (2) 10 weeks after assessments, adaptation and intervention
Primary Changes body composition The body composition was evaluated through deuterium oxide Two times: (1) First day and (2) 10 weeks after assessments, adaptation and intervention
Primary Changes indirect calorimetry With a gas analyzer (indirect calorimeter), we evaluated the metabolic rate and rest (REE) and oxidation of substrates (lipids and carbohydrates) Two times: (1) First day and (2) 10 weeks after assessments, adaptation and intervention
Primary Changes in total cholesterol and lipid fractions Collected in EDTA tubes, were centrifuged. Two times: (1) First day and (2) 10 weeks after assessments, adaptation and intervention
Primary Changes in plasma taurine concentration Collected in EDTA tubes, were centrifuged and the plasma taurine concentration was evaluated using HPLC (high performance liquid chromatography). Two times: (1) First day and (2) 10 weeks after assessments, adaptation and intervention
Primary 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. Two times: (1) First day and (2) 10 weeks after assessments, adaptation and intervention
Primary Changes Food intake Food registry of 3 days. The quantification of the daily intake of nutrients will still be made using sofware. Two times: (1) First day and (2) 10 weeks after assessments, adaptation and intervention
Primary 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. Two times: (1) First day and (2) 10 weeks after assessments, adaptation and intervention
Primary Changes Physical Performance Maximum effort test, according to Wilder, Brennan e Schotte (1993). Two times: (1) First day and (2) 10 weeks after assessments, adaptation and intervention
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