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

January 23, 2018 updated by: Vivian Marques Miguel Suen, University of Sao Paulo

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Control group (CTr)
No counseling or nutritional therapy and no exercise
Other: CTR
no counseling or nutritional therapy and no exercise
Experimental: Moderate intensity continuous training (MICT)

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
Other: MICT
no counseling or nutritional therapy. 8 weeks of individualized and supervised ergometer-based moderate continuous intensity training (MICT).
Experimental: High Intensity Interval Training (HIIT)

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammatory profile
Time Frame: 8 weeks (baseline to 8 week follow-up assessment)
C-reactive protein (CRP) (mg/dL)
8 weeks (baseline to 8 week follow-up assessment)
Inflammatory profile
Time Frame: 8 weeks (baseline to 8 week follow-up assessment)
Interleukin 6 (IL-6) (ng/mL)
8 weeks (baseline to 8 week follow-up assessment)
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)
8 weeks (baseline to 8 week follow-up assessment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
8 weeks (baseline to 8 week follow-up assessment) ]
Body Composition and Anthropometric profile
Time Frame: 8 weeks (baseline to 8 week follow-up assessment) ]
Body Mass Index (BMI) (kg/m²)
8 weeks (baseline to 8 week follow-up assessment) ]
Body Composition and Anthropometric profile
Time Frame: 8 weeks (baseline to 8 week follow-up assessment) ]
Waist circumference (cm), hip circumference (cm)
8 weeks (baseline to 8 week follow-up assessment) ]
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)
8 weeks (baseline to 8 week follow-up assessment) ]
Insulin sensitivity
Time Frame: 8 weeks (baseline to 8 week follow-up assessment) ]
Insulin sensitivity was estimated using homeostasis model assessment index (HOMA)
8 weeks (baseline to 8 week follow-up assessment) ]
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)
8 weeks (baseline to 8 week follow-up assessment) ]
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 weeks (baseline to 8 week follow-up assessment) ]
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)
8 weeks (baseline to 8 week follow-up assessment) ]
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)
8 weeks (baseline to 8 week follow-up assessment) ]
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)
8 weeks (baseline to 8 week follow-up assessment) ]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Study Director: Vivian M M SUEN, PhD, fmrp usp

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

January 8, 2018

Study Completion (Actual)

January 8, 2018

Study Registration Dates

First Submitted

January 9, 2018

First Submitted That Met QC Criteria

January 23, 2018

First Posted (Actual)

January 24, 2018

Study Record Updates

Last Update Posted (Actual)

January 24, 2018

Last Update Submitted That Met QC Criteria

January 23, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Aerobic exercise and obesity

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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