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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06579508
Enrollment
50
Registered
2024-08-30
Start date
2025-03-01
Completion date
2025-12-31
Last updated
2025-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Mitochondrial disfunction, Oxidative stress, Inter-effort Hypoxia, Physical Exercise, Obesity

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.

Interventions

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.

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo
CollaboratorOTHER_GOV
University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Participants will be randomly distributed into 5 groups: Control; Normoxia + placebo (Nor-P); Normoxia + taurine (Nor-T); Hypoxia + placebo (Hyp-P); Hypoxia + Taurine (Hyp-T). Control group is the only group without training

Intervention model description

Randomized clinical trial

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 45 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Muscle biopsy - Mitochondria12 weeksAfter biopsy the tissue will be treated for: High-resolution respirometry of muscle fibers analysis.
Food quality12 weeksThe 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 rates12 weeksThe 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 - RNA12 weeksAfter biopsy the tissue will be treated for: qPCR analysis.
Muscle biopsy - Protein12 weeksAfter biopsy the tissue will be treated for: Western blotting analysis.
Body composition - Free-fat mass12 weeksDual energy x-ray absorptiometry (DEXA) will be use for: Changes in body composition for fat-free mass (grams and %).
Anthropometry - Height12 weeksDual energy x-ray absorptiometry (DEXA) will be use for: Height measured in meters.
Anthropometry - Weight12 weeksDual energy x-ray absorptiometry (DEXA) will be use for: Changes in body weight in kilograms (kg).
Anthropometry - BMI12 weeksDual energy x-ray absorptiometry (DEXA) will be use for: Changes in body mass index (BMI = weight measured(kg) / (height (m)²).
Body composition - Fat mass12 weeksDual energy x-ray absorptiometry (DEXA) will be use for: Changes in body composition for fat mass (grams and %).
Body composition - Bone12 weeksDual energy x-ray absorptiometry (DEXA) will be use for: Changes in body composition for bone mineral content (g.cm²).
Lipid profile - Cholesterol12 weeksQuantified 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).
Lipid profile - Triglycerides12 weeksQuantified 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 - HDL/LDL12 weeksQuantified 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).
Lipid profile - Glucose12 weeksQuantified 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).
Inflammatory profile - pro inflammatory12 weeksChanges in serum levels of cytokines will be evaluated with MILLIPLEX® Kit. Pro- inflammatory citokines: IL-6, TNF-α (pg/mL).
Inflammatory profile - anti inflammatory12 weeksChanges in serum levels of cytokines will be evaluated with MILLIPLEX® Kit. Ant- inflammatory citokines: IL-10 (pg/mL), Adiponectin (ng/mL).
Aerobic performance - HRAnTh12 weeksPhysical 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 - IAnTh12 weeksPhysical 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 - RPEAnTh12 weeksPhysical 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 - LacAnTh12 weeksPhysical 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 - VO212 weeksPhysical 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 Intake12 weeksA 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 (%)

Secondary

MeasureTime frameDescription
Training measures - TRIMP12 weeksThe 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 - SP0212 weeksThe 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 - HR12 weeksThe heart rate (HR) will be measure in beats per minute (BPM) with Polar clock.
Training measures - RPE12 weeksThe Borg scale will be use to quantify the: Rate of Perceived Effort (RPE) - will be noted after each effort during all the training program.

Countries

Brazil

Contacts

Primary ContactEllen C de Freitas
ellenfreitas@usp.br+55 16 3315-0345

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026