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

NCT06579508 | Recruiting DMC

• 1 other identifier: Hypoxia_Taurine
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Obesity

Keywords

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

Outcome Measures

Primary Outcomes (23)

• 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 Outcomes (4)

• Training measures - RPE

  12 weeks

• Training measures - TRIMP

  12 weeks

• Training measures - SP02

  12 weeks

• Training measures - HR

  12 weeks

Study Arms (5)

Control

NO INTERVENTION

No intervention, only the evaluations will be done.

Normoxia - Placebo

PLACEBO COMPARATOR

High-intensity interval cycle ergometer train, with inter effort normoxia (FiO2 = 21%).

Other: Cycle ergometer

Normoxia - Taurina

PLACEBO COMPARATOR

High-intensity interval cycle ergometer train, with inter effort normoxia (FiO2 = 21%).

Other: Cycle ergometer

Hypoxia - Placebo

PLACEBO COMPARATOR

High-intensity interval cycle ergometer train, with inter effort hypoxia (FiO2 = 12%).

Other: Cycle ergometer

Hypoxia - Taurina

EXPERIMENTAL

High-intensity interval cycle ergometer train, with inter effort hypoxia (FiO2 = 12%).

Other: Cycle ergometer

Interventions

Cycle ergometer OTHER

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.

Also known as: Bike

Hypoxia - Placebo; Hypoxia - Taurina; Normoxia - Placebo; Normoxia - Taurina

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (2)

University of São Paulo, School of Physical Education and Sports of Ribeirão Preto.

Ribeirão Preto, São Paulo, 14049-900, Brazil

RECRUITING

University of São Paulo, School of Physical Education and Sports of Ribeirão Preto

Ribeirão Preto, São Paulo, 14049-900, Brazil

RECRUITING

MeSH Terms

Conditions

Obesity; Motor Activity

Interventions

Off-Road Motor Vehicles

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Vehicles; Transportation; Technology, Industry, and Agriculture

Study Officials

• Marcela C Viliod

  USP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ellen C de Freitas

CONTACT

+55 16 3315-0345; ellenfreitas@usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 30, 2024
• Study Start: March 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)