- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04646512
Taurine Supplementation and Exercise on Irisin Levels in Obesity
Effects of Taurine Supplementation Associated With High Intensity Physical Training on Irisin Levels, Energy Expenditure and Body Composition of Obese Women
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
SP
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Ribeirão Preto, SP, Brazil
- Gabriela Batitucci
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Taurine group and exercise
Intervention with taurine supplementation and physical training.
|
Both groups supplemented with taurine and / or placebo will perform physical training.
There will be a physical training for eight weeks.
|
|
PLACEBO_COMPARATOR: Placebo group and exercise
Intervention with placebo supplementation and physical training.
|
Both groups supplemented with taurine and / or placebo will perform physical training.
There will be a physical training for eight weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Two times: (1) First day and (2) 10 weeks after assessments, adaptation and intervention
|
|
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
|
Two times: (1) First day and (2) 10 weeks after assessments, adaptation and intervention
|
|
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)
|
Two times: (1) First day and (2) 10 weeks after assessments, adaptation and intervention
|
|
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.
|
Two times: (1) First day and (2) 10 weeks after assessments, adaptation and intervention
|
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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).
|
Two times: (1) First day and (2) 10 weeks after assessments, adaptation and intervention
|
|
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.
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Two times: (1) First day and (2) 10 weeks after assessments, adaptation and intervention
|
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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.
|
Two times: (1) First day and (2) 10 weeks after assessments, adaptation and intervention
|
|
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.
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Two times: (1) First day and (2) 10 weeks after assessments, adaptation and intervention
|
|
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).
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Two times: (1) First day and (2) 10 weeks after assessments, adaptation and intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 51921115500005426
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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