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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Sao Paulo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 8, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 8, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 9, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 24, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 24, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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