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Completed

NCT Number: NCT03409172

Inflammatory and Metabolic Outcomes After Obese Woman Performed High Intensity Interval Training

The main purpose of this study is to compare the effects of high intensity interval training and moderate intensity continuous training on inflammatory profile and metabolic markers, after 8 weeks of intervention trial in obese women.

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Key information

Conditions

Obesity and Metabolic Syndrome Body Weight Glucose Metabolism Disorders Hyperinsulinism Inflammation Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–41 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body Mass Index between (30-40 kg/m²)
  • age between 25 and 41 years
  • to be sedentary

Exclusion criteria

  • type 1 or type 2 diabetes
  • Hypertension
  • pregnancy, Lactation
  • having undergone bariatric surgery
  • psychological disorders, epilepsy, sever neurological disorders
  • participation in other moderate, vigorous exercise or nutrition intervention
  • acute or chronic cardiovascular disease
  • malignant disease
  • kidney disease
  • lung disease
  • hyperthyroidism or hypothyroidism
  • smoking any type of cigarette
  • joint limitations
  • electronic implants (defibrillator, pacemaker)

Treatment and study plan

CTR

Other

no counseling or nutritional therapy and no exercise

MICT

Other

no counseling or nutritional therapy. 8 weeks of individualized and supervised ergometer-based moderate continuous intensity training (MICT).

HIIT

Other

no counseling or nutritional therapy. 8 weeks of individualized and supervised ergometer-based high intensity interval training (HIIT)

Primary outcomes

  1. Inflammatory profile

    Time frame: 8 weeks (baseline to 8 week follow-up assessment)

    C-reactive protein (CRP) (mg/dL)

  2. Inflammatory profile

    Time frame: 8 weeks (baseline to 8 week follow-up assessment)

    Interleukin 6 (IL-6) (ng/mL)

  3. Inflammatory profile

    Time frame: 8 weeks (baseline to 8 week follow-up assessment)

    Interleukin 10 (IL-10) pg/mL, Interleukin-1B (IL-1B) pg/mL, Tumor Necrosis Factor (TNF)-α (pg/mL), Adiponectin (pg/mL), Monocyte chemoattractant protein 1 (MCP-1) (pg/mL), Leptin (pg/mL)

Secondary outcomes

  1. Body Composition and Anthropometric profile

    Time frame: 8 weeks (baseline to 8 week follow-up assessment) ]

    Body weight (kg), Fat free mass (FFM) (kg), fat mass (FM) (kg)

  2. Body Composition and Anthropometric profile

    Time frame: 8 weeks (baseline to 8 week follow-up assessment) ]

    Body Mass Index (BMI) (kg/m²)

  3. Body Composition and Anthropometric profile

    Time frame: 8 weeks (baseline to 8 week follow-up assessment) ]

    Waist circumference (cm), hip circumference (cm)

  4. Body Composition and Anthropometric profile

    Time frame: 8 weeks (baseline to 8 week follow-up assessment) ]

    Body Adiposity Index (BAI) and Waist-To-Hip Ratio (WHR)

  5. Insulin sensitivity

    Time frame: 8 weeks (baseline to 8 week follow-up assessment) ]

    Insulin sensitivity was estimated using homeostasis model assessment index (HOMA)

  6. Lipid profile

    Time frame: 8 weeks (baseline to 8 week follow-up assessment) ]

    Lipid profile was assessed by measuring levels of triglyceride (TG) (mg/dL), total cholesterol (CT) (mg/dL), high-density lipoprotein cholesterol (HDL-C) (mg/dL) and low-density lipoprotein cholesterol (LDL-C) (mg/dL)

  7. Cardiorespiratory Fitness (CRF)

    Time frame: 8 weeks (baseline to 8 week follow-up assessment) ]

    CRF was assessed by measuring Peak Oxygen uptake (VO2peak) mL/kg/min

  8. Blood Pressure (BP)

    Time frame: 8 weeks (baseline to 8 week follow-up assessment) ]

    Blood Pressure (mmHg) was assessed by measuring rest levels of Systolic blood pressure (SBP) and Diastolic blood pressure (DBP)

  9. Resting Energy Expenditure (REE)

    Time frame: 8 weeks (baseline to 8 week follow-up assessment) ]

    Resting Energy Expenditure (kcal/day) was measured through indirect calorimetry with an open-circuit ventilated-hood system Substrate oxidation rate was calculated from VO2 (mL/min) and VCO2 (mL/min)

  10. Substrate oxidation rate

    Time frame: 8 weeks (baseline to 8 week follow-up assessment) ]

    Substrate oxidation rate was calculated from VO2 (mL/min) and VCO2 (mL/min)

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

Inflammatory and Metabolic Outcomes in Obese Women After 8 Weeks of High Intensity Interval Training and Moderate Intensity Continuous Training: a Randomized Controlled Pilot Study

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 24, 2018
Registry last updated
Jan 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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