Effects of High-intensity Exercise With Hypoxia and Taurine Supplementation on Metabolic and Mitochondrial Parameters

Not Applicable

Not yet recruiting

• Conditions: Obesity
• Interventions: Other: Cycle ergometer

• Registration Number: NCT06579508
• Lead Sponsor: University of Sao Paulo

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.

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-20
• Study First Submitted QC: 2024-08-27
• Last Update Submitted: 2024-08-27
• Study First Posted: 2024-08-30
• Last Update Posted: 2024-08-30
• Study Start: 2025-03
• Primary Completion: 2025-07
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 50

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normoxia - Placebo	Cycle ergometer	High-intensity interval cycle ergometer train, with inter effort normoxia (FiO2 = 21%).
Normoxia - Taurina	Cycle ergometer	High-intensity interval cycle ergometer train, with inter effort normoxia (FiO2 = 21%).
Hypoxia - Placebo	Cycle ergometer	High-intensity interval cycle ergometer train, with inter effort hypoxia (FiO2 = 12%).
Hypoxia - Taurina	Cycle ergometer	High-intensity interval cycle ergometer train, with inter effort hypoxia (FiO2 = 12%).

Primary Outcome Measures

Name	Time	Method
Anthropometry - Height	12 weeks	Dual energy x-ray absorptiometry (DEXA) will be use for: Height measured in meters.
Anthropometry - Weight	12 weeks	Dual energy x-ray absorptiometry (DEXA) will be use for: Changes in body weight in kilograms (kg).
Anthropometry - BMI	12 weeks	Dual energy x-ray absorptiometry (DEXA) will be use for: Changes in body mass index (BMI = weight measured(kg) / (height (m)²).
Lipid profile - Cholesterol	12 weeks	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).
Body composition - Fat mass	12 weeks	Dual energy x-ray absorptiometry (DEXA) will be use for: Changes in body composition for fat mass (grams and %).
Body composition - Free-fat mass	12 weeks	Dual energy x-ray absorptiometry (DEXA) will be use for: Changes in body composition for fat-free mass (grams and %).
Inflammatory profile - pro inflammatory	12 weeks	Changes in serum levels of cytokines will be evaluated with MILLIPLEX® Kit. Pro- inflammatory citokines: IL-6, TNF-α (pg/mL).
Inflammatory profile - anti inflammatory	12 weeks	Changes in serum levels of cytokines will be evaluated with MILLIPLEX® Kit. Ant- inflammatory citokines: IL-10 (pg/mL), Adiponectin (ng/mL).
Aerobic performance - HRAnTh	12 weeks	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).
Aerobic performance - IAnTh	12 weeks	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).
Aerobic performance - RPEAnTh	12 weeks	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).
Aerobic performance - LacAnTh	12 weeks	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 \[lac-\].
Aerobic performance - VO2	12 weeks	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.
Food Intake	12 weeks	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 (%)
Food quality	12 weeks	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.
Taurine rates	12 weeks	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.
Muscle biopsy - RNA	12 weeks	After biopsy the tissue will be treated for: qPCR analysis.
Muscle biopsy - Protein	12 weeks	After biopsy the tissue will be treated for: Western blotting analysis.
Muscle biopsy - Mitochondria	12 weeks	After biopsy the tissue will be treated for: High-resolution respirometry of muscle fibers analysis.
Lipid profile - HDL/LDL	12 weeks	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).
Body composition - Bone	12 weeks	Dual energy x-ray absorptiometry (DEXA) will be use for: Changes in body composition for bone mineral content (g.cm²).
Lipid profile - Triglycerides	12 weeks	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).
Lipid profile - Glucose	12 weeks	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).

Secondary Outcome Measures

Name	Time	Method
Training measures - RPE	12 weeks	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.
Training measures - TRIMP	12 weeks	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.
Training measures - SP02	12 weeks	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.
Training measures - HR	12 weeks	The heart rate (HR) will be measure in beats per minute (BPM) with Polar clock.

Trial Locations

Locations (2)

University of São Paulo, School of Physical Education and Sports of Ribeirão Preto.; 🇧🇷 Ribeirão Preto, São Paulo, Brazil

University of São Paulo, School of Physical Education and Sports of Ribeirão Preto; 🇧🇷 Ribeirão Preto, São Paulo, Brazil