NCT04646512

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 30, 2020

Completed
Last Updated

November 30, 2020

Status Verified

November 1, 2020

Enrollment Period

3 months

First QC Date

November 20, 2020

Last Update Submit

November 20, 2020

Conditions

Keywords

ObesityExerciseIrisinTaurineEnergy Expenditure

Outcome Measures

Primary Outcomes (9)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Taurine group and exercise

ACTIVE COMPARATOR

Intervention with taurine supplementation and physical training.

Dietary Supplement: Taurine group and exercise and placebo group and exerciseOther: Physical training with Deep Water Running

Placebo group and exercise

PLACEBO COMPARATOR

Intervention with placebo supplementation and physical training.

Dietary Supplement: Taurine group and exercise and placebo group and exerciseOther: Physical training with Deep Water Running

Interventions

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

Placebo group and exerciseTaurine group and exercise

There will be a physical training for eight weeks.

Placebo group and exerciseTaurine group and exercise

Eligibility Criteria

Age25 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gabriela Batitucci

Ribeirão Preto, São Paulo, Brazil

Location

MeSH Terms

Conditions

ObesityMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Intervention with taurine and / or placebo supplementation and physical training
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: double blind trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 20, 2020

First Posted

November 30, 2020

Study Start

February 1, 2016

Primary Completion

May 1, 2016

Study Completion

August 1, 2016

Last Updated

November 30, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations