ObesityNCT04646512
Taurine Supplementation and Exercise on Irisin Levels in Obesity
A study testing Physical training with Deep Water Running in people with Obesity, run by University of Sao Paulo at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 25 to 45 years, women only
- Conditions the study is for
- Obesity
- What is being tested?
- Physical training with Deep Water Running
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Feb 2016to 1 Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- This study included women with obesity grade I (BMI ≥30 - ≤35Kg/m²), sedentary, with no associated comorbidity, convenience sample.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Taurine Supplementation Associated With High Intensity Physical Training on Irisin Levels, Energy Expenditure and Body Composition of Obese Women
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).
- Conditions
- Obesity
- Being tested
- Taurine group and exercise and placebo group and exercise, Physical training with Deep Water Running
- Keywords
- Obesity, Exercise, Irisin, Taurine, Energy Expenditure
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taurine group and exercise and placebo group and exerciseDietary supplement
Both groups supplemented with taurine and / or placebo will perform physical training.
Physical training with Deep Water RunningOther
There will be a physical training for eight weeks.
| Study group | Role | What they receive |
|---|---|---|
| Taurine group and exercise | Active comparator | Intervention with taurine supplementation and physical training. Receives: Dietary Supplement: Taurine group and exercise and placebo group and exercise; Other: Physical training with Deep Water Running |
| Placebo group and exercise | Placebo comparator | Intervention with placebo supplementation and physical training. Receives: Dietary Supplement: Taurine group and exercise and placebo group and exercise; Other: Physical training with Deep Water Running |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes body weight
The body weight was measured by digital balance before and after the intervention
Measured: Two times: (1) First day and (2) 10 weeks after assessments, adaptation and intervention
Changes body composition
The body composition was evaluated through deuterium oxide
Measured: Two times: (1) First day and (2) 10 weeks after assessments, adaptation and intervention
Changes indirect calorimetry
With a gas analyzer (indirect calorimeter), we evaluated the metabolic rate and rest (REE) and oxidation of substrates (lipids and carbohydrates)
Measured: Two times: (1) First day and (2) 10 weeks after assessments, adaptation and intervention
Changes in total cholesterol and lipid fractions
Collected in EDTA tubes, were centrifuged.
Measured: Two times: (1) First day and (2) 10 weeks after assessments, adaptation and intervention
Changes in plasma taurine concentration
Collected in EDTA tubes, were centrifuged and the plasma taurine concentration was evaluated using HPLC (high performance liquid chromatography).
Measured: Two times: (1) First day and (2) 10 weeks after assessments, adaptation and intervention
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.
Measured: Two times: (1) First day and (2) 10 weeks after assessments, adaptation and intervention
Changes Food intake
Food registry of 3 days. The quantification of the daily intake of nutrients will still be made using sofware.
Measured: Two times: (1) First day and (2) 10 weeks after assessments, adaptation and intervention
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.
Measured: Two times: (1) First day and (2) 10 weeks after assessments, adaptation and intervention
Changes Physical Performance
Maximum effort test, according to Wilder, Brennan e Schotte (1993).
Measured: Two times: (1) First day and (2) 10 weeks after assessments, adaptation and intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2020
- Study start1 Feb 2016
- Primary completion1 May 2016
- Study completion1 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double blind trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ellen Cristini de Freitas, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04646512
- Sponsor's protocol ID
- 51921115500005426
- Status last verified
- Nov 2020
- First submitted
- 20 Nov 2020
- Last updated
- 30 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Taurine Supplementation Associated With High Intensity Physical Training on Irisin Levels, Energy Expenditure and Body Composition of Obese Women
- ClinicalTrials.gov ID
- NCT04646512
- Acronym / sponsor ID
- 51921115500005426
- Conditions
- Obesity
- Keywords
- Obesity, Exercise, Irisin, Taurine, Energy Expenditure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 1 May 2016 (actual)
- Study completion
- 1 Aug 2016 (actual)
- First posted
- 30 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- double blind trial
| Arm | Type | Receives |
|---|---|---|
| Taurine group and exercise | Active comparator | Dietary Supplement: Taurine group and exercise and placebo group and exercise, Other: Physical training with Deep Water RunningIntervention with taurine supplementation and physical training. |
| Placebo group and exercise | Placebo comparator | Dietary Supplement: Taurine group and exercise and placebo group and exercise, Other: Physical training with Deep Water RunningIntervention with placebo supplementation and physical training. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- This study included women with obesity grade I (BMI ≥30 - ≤35Kg/m²), sedentary, with no associated comorbidity, convenience sample.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Taurine group and exercise and placebo group and exerciseBoth groups supplemented with taurine and / or placebo will perform physical training. | Dietary supplement | Placebo group and exercise, Taurine group and exercise |
| Physical training with Deep Water RunningThere will be a physical training for eight weeks. | Other | Placebo group and exercise, Taurine group and exercise |
Primary outcome
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
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
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)
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.
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).
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.
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.
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.
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical training with Deep Water Running in people with Obesity, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes body weight (time frame: Two times: (1) First day and (2) 10 weeks after assessments, adaptation and intervention). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2020.