Clinical trial NCT06579508: Effects of High-intensity Exercise With Hypoxia and Taurine Supplementation on Metabolic and Mitochondrial Parameters
Official title: Effects of High-intensity Intermittent Exercise With Recovery Hypoxia and Taurine Supplementation in Women With Obesity on Metabolic and Mitochondrial Parameters
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Keywords: Mitochondrial disfunction
Oxidative stress
Inter-effort Hypoxia
Physical Exercise
Obesity
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2024-08-30
Enrollment: 50
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial
Primary purpose: TREATMENT

Brief summary: The prevalence of obesity in Brazil is one of the highest in Latin America. As an inflammatory disease, obesity needs to be treated, and one of the best interventions is exercise. This research aims to learn more about the effects of combining high-intensity training, recovery hypoxia, and taurine supplementation. To better understand these effects, the researchers will compare hypoxia and normoxia, as well as taurine and placebo, with all participants training in the same way. The researchers will also investigate mitochondrial respiration and food consumption to connect certain aspects of obesity with overall health.

Detailed description: Obesity is characterized by a chronic inflammatory state, often linked with elevated oxidative stress and mitochondrial dysfunction. While physical exercise can trigger inflammatory responses due to muscle damage, it also promotes significant bodily adaptations, particularly in body composition, physical fitness, and skeletal muscle tissue, including enhanced mitochondrial dynamics. Moderate hypoxia, when combined with exercise, further amplifies these benefits by increasing the expression of genes related to mitochondrial biogenesis, GLUT1 expression, and angiogenesis. Previous findings suggest that high-intensity physical activity not only improves cardiorespiratory capacity and alters body composition but also significantly elevates inflammation. Consequently, taurine, a supplement known for its anti-inflammatory properties and ability to reduce oxidative stress, should be considered to mitigate these issues and optimize the benefits of exercise and hypoxia. Based on these premises, it is hypothesized that the combination of taurine supplementation with physical training under recovery hypoxia may reduce the significant rise in pro-inflammatory cytokines, thereby enhancing the potential benefits of exercise and moderate hypoxia.

Eligibility criteria: Inclusion Criteria:

* Women
* Age between 25 - 45 years old;
* BMI between 30 - 35kg/m²;
* Not be on a diet;
* Not be on a physical activity program;
* Not be menopaused.

Exclusion Criteria:

* Smokers;
* Alcoholics;
* Use thyroid medication;
* Carry out nutritional monitoring or in treatment for weight loss;
* Hypertension;
* Metabolical syndrome;
* Have any comorbidity associated to obesity;
* Drugs use.

Primary outcomes:
measure: Anthropometry - Height
timeFrame: 12 weeks
measure: Anthropometry - Weight
timeFrame: 12 weeks
measure: Anthropometry - BMI
timeFrame: 12 weeks
measure: Body composition - Free-fat mass
timeFrame: 12 weeks
measure: Body composition - Fat mass
timeFrame: 12 weeks
measure: Body composition - Bone
timeFrame: 12 weeks
measure: Lipid profile - Cholesterol
timeFrame: 12 weeks
measure: Lipid profile - Triglycerides
timeFrame: 12 weeks
measure: Lipid profile - HDL/LDL
timeFrame: 12 weeks
measure: Lipid profile - Glucose
timeFrame: 12 weeks
measure: Inflammatory profile - pro inflammatory
timeFrame: 12 weeks
measure: Inflammatory profile - anti inflammatory
timeFrame: 12 weeks
measure: Aerobic performance - HRAnTh
timeFrame: 12 weeks
measure: Aerobic performance - IAnTh
timeFrame: 12 weeks
measure: Aerobic performance - RPEAnTh
timeFrame: 12 weeks
measure: Aerobic performance - LacAnTh
timeFrame: 12 weeks
measure: Aerobic performance - VO2
timeFrame: 12 weeks
measure: Food Intake
timeFrame: 12 weeks
measure: Food quality
timeFrame: 12 weeks
measure: Taurine rates
timeFrame: 12 weeks
measure: Muscle biopsy - RNA
timeFrame: 12 weeks
measure: Muscle biopsy - Protein
timeFrame: 12 weeks
measure: Muscle biopsy - Mitochondria
timeFrame: 12 weeks
Secondary outcomes:
measure: Training measures - RPE
timeFrame: 12 weeks
measure: Training measures - TRIMP
timeFrame: 12 weeks
measure: Training measures - SP02
timeFrame: 12 weeks
measure: Training measures - HR
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: University of São Paulo, School of Physical Education and Sports of Ribeirão Preto.
state: São Paulo
city: Ribeirão Preto
country: Brazil
facility: University of São Paulo, School of Physical Education and Sports of Ribeirão Preto
state: São Paulo
Study officials:
affiliation: USP
name: Marcela C Viliod
role: PRINCIPAL_INVESTIGATOR
References: