Effects of High-intensity Exercise With Hypoxia and Taurine Supplementation on Metabolic and Mitochondrial Parameters
NCT Number: NCT06579508
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Obesity
Interventions: OTHER: Cycle ergometer
Sponsor: University of Sao Paulo
Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
Sex: FEMALE
Age: ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2025-03
Completion Date: 2025-11
Locations: University of São Paulo, School of Physical Education and Sports of Ribeirão Preto., Ribeirão Preto, São Paulo, 14049-900, Brazil|University of São Paulo, School of Physical Education and Sports of Ribeirão Preto, Ribeirão Preto, São Paulo, 14049-900, Brazil

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.

Primary Outcome Measures: Anthropometry - Height, Dual energy x-ray absorptiometry (DEXA) will be use for:

Height measured in meters., 12 weeks|Anthropometry - Weight, Dual energy x-ray absorptiometry (DEXA) will be use for:

Changes in body weight in kilograms (kg)., 12 weeks|Anthropometry - BMI, Dual energy x-ray absorptiometry (DEXA) will be use for:

Changes in body mass index (BMI = weight measured(kg) / (height (m)²)., 12 weeks|Body composition - Free-fat mass, Dual energy x-ray absorptiometry (DEXA) will be use for:

Changes in body composition for fat-free mass (grams and %)., 12 weeks|Body composition - Fat mass, Dual energy x-ray absorptiometry (DEXA) will be use for:

Changes in body composition for fat mass (grams and %)., 12 weeks|Body composition - Bone, Dual energy x-ray absorptiometry (DEXA) will be use for:

Changes in body composition for bone mineral content (g.cm²)., 12 weeks|Lipid profile - Cholesterol, Quantified by Total Liquiform Cholesterol Kit, HDL Cholesterol Kit and Liquiform Triglycerides Kit, from Labtest diagnóstica®, using an enzymatic system and absorbance spectrophotometer:

Changes in total cholesterol (mg/dL)., 12 weeks|Lipid profile - Triglycerides, Quantified by Total Liquiform Cholesterol Kit, HDL Cholesterol Kit and Liquiform Triglycerides Kit, from Labtest diagnóstica®, using an enzymatic system and absorbance spectrophotometer:

Changes in triglycerides (mg/dL)., 12 weeks|Lipid profile - HDL/LDL, Quantified by Total Liquiform Cholesterol Kit, HDL Cholesterol Kit and Liquiform Triglycerides Kit, from Labtest diagnóstica®, using an enzymatic system and absorbance spectrophotometer:

Changes in HDL-cholesterol and LDL-cholesterol (mg/dL)., 12 weeks|Lipid profile - Glucose, Quantified by Total Liquiform Cholesterol Kit, HDL Cholesterol Kit and Liquiform Triglycerides Kit, from Labtest diagnóstica®, using an enzymatic system and absorbance spectrophotometer:

Changes in blood glucose (mg/dL)., 12 weeks|Inflammatory profile - pro inflammatory, Changes in serum levels of cytokines will be evaluated with MILLIPLEX® Kit. Pro- inflammatory citokines: IL-6, TNF-α (pg/mL)., 12 weeks|Inflammatory profile - anti inflammatory, Changes in serum levels of cytokines will be evaluated with MILLIPLEX® Kit. Ant- inflammatory citokines: IL-10 (pg/mL), Adiponectin (ng/mL)., 12 weeks|Aerobic performance - HRAnTh, Physical tests performed pre-, after 6 weeks and post- intervention to assess aerobic physical fitness by incremental test in cycle ergometer. The test aim to evaluate:

Anaerobic threshold (AT) using heart rate (HR)., 12 weeks|Aerobic performance - IAnTh, Physical tests performed pre-, after 6 weeks and post- intervention to assess aerobic physical fitness by incremental test in cycle ergometer. The test aim to evaluate:

Anaerobic threshold (AT) using intensity in Watts (W)., 12 weeks|Aerobic performance - RPEAnTh, Physical tests performed pre-, after 6 weeks and post- intervention to assess aerobic physical fitness by incremental test in cycle ergometer. The test aim to evaluate:

Anaerobic threshold (AT) using Rate of Perceived Effort (RPE)., 12 weeks|Aerobic performance - LacAnTh, Physical tests performed pre-, after 6 weeks and post- intervention to assess aerobic physical fitness by incremental test in cycle ergometer. The test aim to evaluate:

Anaerobic threshold (AT) using lactate concentration \[lac-\]., 12 weeks|Aerobic performance - VO2, Physical tests performed pre-, after 6 weeks and post- intervention to assess aerobic physical fitness by incremental test in cycle ergometer. The test aim to evaluate:

VO2peak in ml.kg-1.min-1., 12 weeks|Food Intake, A food record of three non-consecutive days: two days of the week and one day in the weekend. This evaluation will last 12 weeks. Will be evaluated with Dietwin® software (São Paulo, Brazil):

The macronutrients, micronutrients and fiber in quilocalories and percentage (%), 12 weeks|Food quality, The feed will undergo analysis through the NOVA Classification. By NOVA, food will be classified into four groups: Group 1 - Unprocessed or minimally processed foods; Group 2 - Processed culinary ingredients; Group 3 - Processed foods; Group 4 - Ultra-processed foods.

For each category, the total calories ingested will be calculated, and later, represented in percentage (%) the participation of each food group in the general diet., 12 weeks|Taurine rates, The participants will supplement 3g of taurina or placebo during 12 weeks. The rate of plasmatic taurine (mmol) will be evaluated during pre and post intervention., 12 weeks|Muscle biopsy - RNA, After biopsy the tissue will be treated for:

qPCR analysis., 12 weeks|Muscle biopsy - Protein, After biopsy the tissue will be treated for:

Western blotting analysis., 12 weeks|Muscle biopsy - Mitochondria, After biopsy the tissue will be treated for:

High-resolution respirometry of muscle fibers analysis., 12 weeks
Secondary Outcome Measures: Training measures - RPE, The Borg scale will be use to quantify the:

Rate of Perceived Effort (RPE) - will be noted after each effort during all the training program., 12 weeks|Training measures - TRIMP, The internal load will be calculated using TRIMP:

Calculated multipling the RPE for the time in effort (TRIMP = RPE \* time in effort), for each participant and training session., 12 weeks|Training measures - SP02, The Oxygen saturation (SpO2) will be measure in percent (%), using a pulse oximeter.

SpO2 (%) will be noted after the end of the effort, the lowest point during the rest and in the end of the rest., 12 weeks|Training measures - HR, The heart rate (HR) will be measure in beats per minute (BPM) with Polar clock., 12 weeks