Clinical trial NCT04279600: Taurine Supplementation and Training Effects on Energy Metabolism, Inflammation and Oxidative Stress in Obese Women
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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2020-02-21
Enrollment: 24
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind placebo controlled study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline in white adipose tissue mitochondrial respiration at 8 weeks
timeFrame: eight weeks
measure: Change from baseline in indirect calorimetry at 8 weeks
timeFrame: eight weeks
measure: Changes from baseline in interleukines levels at 8 weeks
timeFrame: eight weeks
measure: Changes from baseline in cytokine levels at 8 weeks
timeFrame: eight weeks
measure: Changes from baseline in glutathione peroxidase levels at 8 weeks
timeFrame: eight weeks
measure: Changes from baseline in superoxide dismutase levels at 8 weeks
timeFrame: eight weeks
measure: Changes from baseline in macronutrient intake at 8 weeks
timeFrame: eight weeks
measure: Changes from baseline in total calorie intake at 8 weeks
timeFrame: eight weeks
measure: Changes from baseline in body composition at 8 weeks
timeFrame: eight weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: School of Physical Education and Sport of Ribeirão Preto
state: Sao Paulo
Study officials:
affiliation: University of Sao Paulo
name: Ellen C Freitas, PhD
role: PRINCIPAL_INVESTIGATOR
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