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

Primary Purpose

Obesity and Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CTR
MICT
HIIT
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity and Metabolic Syndrome focused on measuring High intensity interval training, Inflammation, Obesity, adipokines

Eligibility Criteria

25 Years - 41 Years (Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Control group (CTr)

    Moderate intensity continuous training (MICT)

    High Intensity Interval Training (HIIT)

    Arm Description

    No counseling or nutritional therapy and no exercise

    Follow-up during a period of 8 weeks of supervised ergometer-based moderate-intensity continuous training based on HRmax (MICT). MICT: 3 sessions per week intensity at 65-75% HRmax time-effort per session: 50 min

    Procedures: Follow-up during a period of 8 weeks of supervised ergometer-based high intensity interval training based on HRmax (HIIT). HIIT: 3 sessions per week 10 bouts of one minute at 90% HRmax interspersed by one minute at 40% HRmax time-effort per session: 25 min

    Outcomes

    Primary Outcome Measures

    Inflammatory profile
    C-reactive protein (CRP) (mg/dL)
    Inflammatory profile
    Interleukin 6 (IL-6) (ng/mL)
    Inflammatory profile
    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 Outcome Measures

    Body Composition and Anthropometric profile
    Body weight (kg), Fat free mass (FFM) (kg), fat mass (FM) (kg)
    Body Composition and Anthropometric profile
    Body Mass Index (BMI) (kg/m²)
    Body Composition and Anthropometric profile
    Waist circumference (cm), hip circumference (cm)
    Body Composition and Anthropometric profile
    Body Adiposity Index (BAI) and Waist-To-Hip Ratio (WHR)
    Insulin sensitivity
    Insulin sensitivity was estimated using homeostasis model assessment index (HOMA)
    Lipid profile
    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)
    Cardiorespiratory Fitness (CRF)
    CRF was assessed by measuring Peak Oxygen uptake (VO2peak) mL/kg/min
    Blood Pressure (BP)
    Blood Pressure (mmHg) was assessed by measuring rest levels of Systolic blood pressure (SBP) and Diastolic blood pressure (DBP)
    Resting Energy Expenditure (REE)
    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)
    Substrate oxidation rate
    Substrate oxidation rate was calculated from VO2 (mL/min) and VCO2 (mL/min)

    Full Information

    First Posted
    January 9, 2018
    Last Updated
    January 23, 2018
    Sponsor
    University of Sao Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03409172
    Brief Title
    Inflammatory and Metabolic Outcomes After Obese Woman Performed High Intensity Interval Training
    Official 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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1, 2016 (Actual)
    Primary Completion Date
    January 8, 2018 (Actual)
    Study Completion Date
    January 8, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Sao Paulo

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity and Metabolic Syndrome
    Keywords
    High intensity interval training, Inflammation, Obesity, adipokines

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Three-arm parallel, Randomized-controlled study
    Masking
    Outcomes Assessor
    Masking Description
    Outcome Assessors involved in data analysis will not be aware of the arm to which the participants were allocated (single-blinded masking)
    Allocation
    Randomized
    Enrollment
    48 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group (CTr)
    Arm Type
    Experimental
    Arm Description
    No counseling or nutritional therapy and no exercise
    Arm Title
    Moderate intensity continuous training (MICT)
    Arm Type
    Experimental
    Arm Description
    Follow-up during a period of 8 weeks of supervised ergometer-based moderate-intensity continuous training based on HRmax (MICT). MICT: 3 sessions per week intensity at 65-75% HRmax time-effort per session: 50 min
    Arm Title
    High Intensity Interval Training (HIIT)
    Arm Type
    Experimental
    Arm Description
    Procedures: Follow-up during a period of 8 weeks of supervised ergometer-based high intensity interval training based on HRmax (HIIT). HIIT: 3 sessions per week 10 bouts of one minute at 90% HRmax interspersed by one minute at 40% HRmax time-effort per session: 25 min
    Intervention Type
    Other
    Intervention Name(s)
    CTR
    Intervention Description
    no counseling or nutritional therapy and no exercise
    Intervention Type
    Other
    Intervention Name(s)
    MICT
    Intervention Description
    no counseling or nutritional therapy. 8 weeks of individualized and supervised ergometer-based moderate continuous intensity training (MICT).
    Intervention Type
    Other
    Intervention Name(s)
    HIIT
    Intervention Description
    no counseling or nutritional therapy. 8 weeks of individualized and supervised ergometer-based high intensity interval training (HIIT)
    Primary Outcome Measure Information:
    Title
    Inflammatory profile
    Description
    C-reactive protein (CRP) (mg/dL)
    Time Frame
    8 weeks (baseline to 8 week follow-up assessment)
    Title
    Inflammatory profile
    Description
    Interleukin 6 (IL-6) (ng/mL)
    Time Frame
    8 weeks (baseline to 8 week follow-up assessment)
    Title
    Inflammatory profile
    Description
    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)
    Time Frame
    8 weeks (baseline to 8 week follow-up assessment)
    Secondary Outcome Measure Information:
    Title
    Body Composition and Anthropometric profile
    Description
    Body weight (kg), Fat free mass (FFM) (kg), fat mass (FM) (kg)
    Time Frame
    8 weeks (baseline to 8 week follow-up assessment) ]
    Title
    Body Composition and Anthropometric profile
    Description
    Body Mass Index (BMI) (kg/m²)
    Time Frame
    8 weeks (baseline to 8 week follow-up assessment) ]
    Title
    Body Composition and Anthropometric profile
    Description
    Waist circumference (cm), hip circumference (cm)
    Time Frame
    8 weeks (baseline to 8 week follow-up assessment) ]
    Title
    Body Composition and Anthropometric profile
    Description
    Body Adiposity Index (BAI) and Waist-To-Hip Ratio (WHR)
    Time Frame
    8 weeks (baseline to 8 week follow-up assessment) ]
    Title
    Insulin sensitivity
    Description
    Insulin sensitivity was estimated using homeostasis model assessment index (HOMA)
    Time Frame
    8 weeks (baseline to 8 week follow-up assessment) ]
    Title
    Lipid profile
    Description
    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)
    Time Frame
    8 weeks (baseline to 8 week follow-up assessment) ]
    Title
    Cardiorespiratory Fitness (CRF)
    Description
    CRF was assessed by measuring Peak Oxygen uptake (VO2peak) mL/kg/min
    Time Frame
    8 weeks (baseline to 8 week follow-up assessment) ]
    Title
    Blood Pressure (BP)
    Description
    Blood Pressure (mmHg) was assessed by measuring rest levels of Systolic blood pressure (SBP) and Diastolic blood pressure (DBP)
    Time Frame
    8 weeks (baseline to 8 week follow-up assessment) ]
    Title
    Resting Energy Expenditure (REE)
    Description
    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)
    Time Frame
    8 weeks (baseline to 8 week follow-up assessment) ]
    Title
    Substrate oxidation rate
    Description
    Substrate oxidation rate was calculated from VO2 (mL/min) and VCO2 (mL/min)
    Time Frame
    8 weeks (baseline to 8 week follow-up assessment) ]

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    41 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Vivian M M SUEN, PhD
    Organizational Affiliation
    fmrp usp
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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