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

Effects of High-intensity Intermittent Exercise With Recovery Hypoxia and Taurine Supplementation in Women With Obesity on Metabolic and Mitochondrial Parameters

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity
• Intervention / Treatment: Other: Cycle ergometer

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Ribeirão Preto, São Paulo, Brazil, 14049-900
      • University of São Paulo, School of Physical Education and Sports of Ribeirão Preto
    • Ribeirão Preto, São Paulo, Brazil, 14049-900
      • University of São Paulo, School of Physical Education and Sports of Ribeirão Preto.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; No intervention, only the evaluations will be done.
Placebo Comparator: Normoxia - Placebo; High-intensity interval cycle ergometer train, with inter effort normoxia (FiO2 = 21%).	Other: Cycle ergometer; The initial part will last 5 minutes at low intensity, corresponding to "easy" by the RPE. The main part will be performed at the intensity of training zone 3 (100-110% of the Lan), lasting 5 minutes with a rest of 2.5 minutes between exercises. The intensity will be controlled by HR and RPE. The final part will last 3 minutes at low intensity, corresponding to "easy" by the RPE. The load progression occurred during the first four weeks, starting with 3 sets and adding 1 set per week. The intensity of each effort is 100-110%HRAnTh.; Other Names: Bike
Placebo Comparator: Normoxia - Taurina; High-intensity interval cycle ergometer train, with inter effort normoxia (FiO2 = 21%).	Other: Cycle ergometer; The initial part will last 5 minutes at low intensity, corresponding to "easy" by the RPE. The main part will be performed at the intensity of training zone 3 (100-110% of the Lan), lasting 5 minutes with a rest of 2.5 minutes between exercises. The intensity will be controlled by HR and RPE. The final part will last 3 minutes at low intensity, corresponding to "easy" by the RPE. The load progression occurred during the first four weeks, starting with 3 sets and adding 1 set per week. The intensity of each effort is 100-110%HRAnTh.; Other Names: Bike
Placebo Comparator: Hypoxia - Placebo; High-intensity interval cycle ergometer train, with inter effort hypoxia (FiO2 = 12%).	Other: Cycle ergometer; The initial part will last 5 minutes at low intensity, corresponding to "easy" by the RPE. The main part will be performed at the intensity of training zone 3 (100-110% of the Lan), lasting 5 minutes with a rest of 2.5 minutes between exercises. The intensity will be controlled by HR and RPE. The final part will last 3 minutes at low intensity, corresponding to "easy" by the RPE. The load progression occurred during the first four weeks, starting with 3 sets and adding 1 set per week. The intensity of each effort is 100-110%HRAnTh.; Other Names: Bike
Experimental: Hypoxia - Taurina; High-intensity interval cycle ergometer train, with inter effort hypoxia (FiO2 = 12%).	Other: Cycle ergometer; The initial part will last 5 minutes at low intensity, corresponding to "easy" by the RPE. The main part will be performed at the intensity of training zone 3 (100-110% of the Lan), lasting 5 minutes with a rest of 2.5 minutes between exercises. The intensity will be controlled by HR and RPE. The final part will last 3 minutes at low intensity, corresponding to "easy" by the RPE. The load progression occurred during the first four weeks, starting with 3 sets and adding 1 set per week. The intensity of each effort is 100-110%HRAnTh.; Other Names: Bike

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
• Investigators: Principal Investigator: Marcela C Viliod, USP

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: August 20, 2024
• First Submitted That Met QC Criteria: August 27, 2024
• First Posted (Actual): August 30, 2024

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Oxidative stress; Obesity; Physical Exercise; Mitochondrial disfunction; Inter-effort Hypoxia
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Motor Activity; Technology, Industry, and Agriculture; Motor Vehicles; Transportation; Off-Road Motor Vehicles
• Other Study ID Numbers: Hypoxia_Taurine

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No