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Taurine Supplementation and Training Effects on Energy Metabolism, Inflammation and Oxidative Stress in Obese Women (Taurine)

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Taurine
Placebo
Exercise training
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Body Mass Index of 30 to 40 kg / m²
  • Sedentary
  • No associated co morbidity

Exclusion Criteria:

  • Women who have a medical impediment to the practice of physical exercise
  • Women that have undergone bariatric surgery
  • Menopause, cancer or any metabolic disease
  • Smokers
  • Alcoholics
  • Insulin-dependent diabetes

Sites / Locations

  • School of Physical Education and Sport of Ribeirão Preto

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Taurine supplementation

Taurine supplementation associated to exercise training

Placebo supplementation associated to exercise training

Arm Description

Taurine supplementation composed of capsules of taurine powder. Dosage: 3 grams/day Frequency: 1 time/day Duration: 8 weeks

Taurine supplementation composed of capsules of taurine powder. Dosage: 3 grams/day Frequency: 1 time/day Duration: 8 weeks Exercise training Exercise Protocol: a combination of strength and aerobic exercises Duration: 2 weeks of adaptation and 8 weeks of physical training. Frequency: 3 times/week Duration: 55 minutes/session Intensity: 75 to 90% of maximum heart rate

Placebo supplementation composed of capsules of starch powder. Dosage: 3 grams/day Frequency: 1 time/day Duration: 8 weeks Exercise training Exercise Protocol: a combination of strength and aerobic exercises Duration: 2 weeks of adaptation and 8 weeks of physical training. Frequency: 3 times/week Duration: 55 minutes/session Intensity: 75 to 90% of maximum heart rate

Outcomes

Primary Outcome Measures

Change from baseline in white adipose tissue mitochondrial respiration at 8 weeks
A subcutaneous adipose tissue sample collected for analysis of mitochondrial respiration (mitochondrial uncoupled state, phosphorylation state and electron transport system maximal capacity) were calculated at 8 weeks in comparison to the baseline.
Change from baseline in indirect calorimetry at 8 weeks
Change of energy expenditure and lipids oxidation were calculated at 8 weeks in comparision to the baseline.
Changes from baseline in interleukines levels at 8 weeks
Change of inflammatory markers such as interleukines 6, 10 and 15 were calculated at 8 weeks in comparision to the baseline.
Changes from baseline in cytokine levels at 8 weeks
Change of inflammatory markers such as adiponectin, resistin and adipsin were calculated at 8 weeks in comparision to the baseline.
Changes from baseline in glutathione peroxidase levels at 8 weeks
Change of oxidative stress markers such as glutathione peroxidase were calculated at 8 weeks in comparision to the baseline.
Changes from baseline in superoxide dismutase levels at 8 weeks
Change of oxidative stress markers such as superoxide dismutase were calculated at 8 weeks in comparision to the baseline.
Changes from baseline in macronutrient intake at 8 weeks
Change of macronutrient intake were calculated at 8 weeks in comparision to the baseline.
Changes from baseline in total calorie intake at 8 weeks
Change of total calorie intake were calculated at 8 weeks in comparision to the baseline.
Changes from baseline in body composition at 8 weeks
Change of body composition through deuterium oxide method were calculated at 8 weeks in comparision to the baseline.

Secondary Outcome Measures

Full Information

First Posted
August 18, 2019
Last Updated
February 23, 2020
Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT04279600
Brief Title
Taurine Supplementation and Training Effects on Energy Metabolism, Inflammation and Oxidative Stress in Obese Women
Acronym
Taurine
Official Title
Taurine Supplementation and Physical Training Effects on Adipose Tissue Mitochondrial Energy Metabolism, and Blood Inflammation and Oxidative Stress in Obese Women
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
September 1, 2017 (Actual)
Study Completion Date
May 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Taurine supplementation researches have increased due to its antioxidant and anti-inflammatory actions, and its ability to modulate lipid metabolism by stimulating the expression of proteins that regulates mitochondrial biogenesis and increases respiratory function (PGC-1α and PPAR) and irisin release when associated to exercise. Since obesity can induce metabolic disorders including abnormal production of adipokines and activation of pro-inflammatory signaling pathways also mitochondrial metabolism dysfunction in the adipose tissue, the use of taurine would be a new strategy for obesity prevention and treatment. Moreover, the association of taurine and exercise could improve exercise effects, promote higher energy expenditure and increase mitochondrial respiration, consequently resulting in weight loss. Therefore, the present investigation aims to evaluate the effects of the association of taurine supplementation and a combined exercise training protocol (aerobic and strength) on resting energy expenditure, weight, body composition, blood markers of inflammation and oxidative stress, telomeres length, and mitochondrial function and the expression of genes that regulates energy metabolism and lipid oxidation in the white adipose tissue in obese women.
Detailed Description
A double-blind placebo-controlled study was conducted with 24 obese women (32.9±6.3 years). Capsules of taurine (3 grams) (GTau) or placebo (GP) were daily supplemented 2 hours before training. The training program was composed of aerobic and strength exercises during one hour, 3 times a week, for an 8-week period (intensity of 80% heart rate). The taurine supplemented group received only taurine capsules (3g/day) during 8 weeks. Measurement of weight, hip and waist circumference, and body composition (by Deuterium oxide) were performed before and after the intervention. Resting energy expenditure and nutrients oxidation were assessed by calorimetry. In order to check the effects of the intervention, abdominal tissue biopsy will be performed for white adipose tissue analysis, evaluation of mitochondrial function and quantification of the expression of genes related to energy metabolism and lipid oxidation and taurine pathway; blood collection will be done for quantification of taurine levels, inflammatory (IL-10, IL-15, IL-6, IL-1, TNF-α, and CRP), adipokines (adiponectin, adipsin, resistin, fetuin and leptin) and oxidative stress (GPx, SOD and MDA) markers. Also, evaluation of telomere length was performed. Body composition was evaluated by deuterium oxide method, weight, waist and hip circumference were accessed. All the measurements were performed before and after the intervention period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double-blind placebo controlled study
Masking
ParticipantInvestigator
Masking Description
Supplement capsule packages were labeled as "Supplement A" and "Supplement B" and the nutrient (taurine or placebo- starch) was revealed after the end of the intervention.
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Taurine supplementation
Arm Type
Experimental
Arm Description
Taurine supplementation composed of capsules of taurine powder. Dosage: 3 grams/day Frequency: 1 time/day Duration: 8 weeks
Arm Title
Taurine supplementation associated to exercise training
Arm Type
Active Comparator
Arm Description
Taurine supplementation composed of capsules of taurine powder. Dosage: 3 grams/day Frequency: 1 time/day Duration: 8 weeks Exercise training Exercise Protocol: a combination of strength and aerobic exercises Duration: 2 weeks of adaptation and 8 weeks of physical training. Frequency: 3 times/week Duration: 55 minutes/session Intensity: 75 to 90% of maximum heart rate
Arm Title
Placebo supplementation associated to exercise training
Arm Type
Placebo Comparator
Arm Description
Placebo supplementation composed of capsules of starch powder. Dosage: 3 grams/day Frequency: 1 time/day Duration: 8 weeks Exercise training Exercise Protocol: a combination of strength and aerobic exercises Duration: 2 weeks of adaptation and 8 weeks of physical training. Frequency: 3 times/week Duration: 55 minutes/session Intensity: 75 to 90% of maximum heart rate
Intervention Type
Dietary Supplement
Intervention Name(s)
Taurine
Intervention Description
Taurine supplementation in capsules of 1 gram of taurine powder, total dosage: 3 grams/day
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo supplementation in capsules of 1 gram of starch powder, total dosage: 3 grams/day
Intervention Type
Other
Intervention Name(s)
Exercise training
Intervention Description
4 weeks of combined exercise training (alternating strength and aerobic exercise), with a frequency of 3 times/week with 55 min/day.
Primary Outcome Measure Information:
Title
Change from baseline in white adipose tissue mitochondrial respiration at 8 weeks
Description
A subcutaneous adipose tissue sample collected for analysis of mitochondrial respiration (mitochondrial uncoupled state, phosphorylation state and electron transport system maximal capacity) were calculated at 8 weeks in comparison to the baseline.
Time Frame
eight weeks
Title
Change from baseline in indirect calorimetry at 8 weeks
Description
Change of energy expenditure and lipids oxidation were calculated at 8 weeks in comparision to the baseline.
Time Frame
eight weeks
Title
Changes from baseline in interleukines levels at 8 weeks
Description
Change of inflammatory markers such as interleukines 6, 10 and 15 were calculated at 8 weeks in comparision to the baseline.
Time Frame
eight weeks
Title
Changes from baseline in cytokine levels at 8 weeks
Description
Change of inflammatory markers such as adiponectin, resistin and adipsin were calculated at 8 weeks in comparision to the baseline.
Time Frame
eight weeks
Title
Changes from baseline in glutathione peroxidase levels at 8 weeks
Description
Change of oxidative stress markers such as glutathione peroxidase were calculated at 8 weeks in comparision to the baseline.
Time Frame
eight weeks
Title
Changes from baseline in superoxide dismutase levels at 8 weeks
Description
Change of oxidative stress markers such as superoxide dismutase were calculated at 8 weeks in comparision to the baseline.
Time Frame
eight weeks
Title
Changes from baseline in macronutrient intake at 8 weeks
Description
Change of macronutrient intake were calculated at 8 weeks in comparision to the baseline.
Time Frame
eight weeks
Title
Changes from baseline in total calorie intake at 8 weeks
Description
Change of total calorie intake were calculated at 8 weeks in comparision to the baseline.
Time Frame
eight weeks
Title
Changes from baseline in body composition at 8 weeks
Description
Change of body composition through deuterium oxide method were calculated at 8 weeks in comparision to the baseline.
Time Frame
eight weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Body Mass Index of 30 to 40 kg / m² Sedentary No associated co morbidity Exclusion Criteria: Women who have a medical impediment to the practice of physical exercise Women that have undergone bariatric surgery Menopause, cancer or any metabolic disease Smokers Alcoholics Insulin-dependent diabetes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen C Freitas, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Physical Education and Sport of Ribeirão Preto
City
Ribeirão Preto
State/Province
Sao Paulo
ZIP/Postal Code
14040-907
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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22237023
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Taurine Supplementation and Training Effects on Energy Metabolism, Inflammation and Oxidative Stress in Obese Women

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