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High-intensity Interval Training in Overweight/Obese

Primary Purpose

Obesity, Metabolically Benign

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Interval training

About this trial

This is an interventional prevention trial for Obesity, Metabolically Benign

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

written and dated informed consent to participate in the study.
willing and able to comply with the protocol.
good health as determined by a health and exercise status questionnaire
normal electrocardiogram (ECG), and physical.
body mass index of 25-45 kg/m 2.
has been cleared for participation by a physician (either study or personal).

Exclusion Criteria:

participating in another clinical trial or have received an investigational product within thirty days prior to enrollment.
has lost ten or more pounds during the previous three months and maintained the weight loss.
significant history or current presence of untreated high blood pressure (BP) [systolic BP> 140 mmHg and/or diastolic BP> 90 mmHg], thyroid disease, tachyarrhythmia, heart disease, kidney disease, or liver disease. Subject currently suffers from/or has a known history of (or is currently being treated for) clinical depression or an eating disorder(s).
has any medical condition or uses any medication, nutritional product, dietary supplement or program, which in the opinion of the investigator, might interfere with the conduct of the study or place the subject at risk.
are identified as moderate to high risk individuals by the American College of Sports Medicine will be excluded from the study.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

High-intensity interval -2min

High-intensity interval -1min

Control

Arm Description

5 bouts of 2 min cycling at varying intensities of VO2peak (80-100%) with 1 min recovery.

10 bouts of 1 min cycling at 90% of VO2peak with 1 min rest periods

No exercise

Outcomes

Primary Outcome Measures

Cardiorespiratory Fitness (VO2peak)

Secondary Outcome Measures

Body Composition

Blood Lipids

Full Information

NCT ID

NCT02444377

First Posted

May 11, 2015

Last Updated

November 29, 2016

Sponsor

University of North Carolina, Chapel Hill

1. Study Identification

Unique Protocol Identification Number

NCT02444377

Brief Title

High-intensity Interval Training in Overweight/Obese

Official Title

Impact of Varying High-intensity Interval Protocols on Cardiometabolic Risk Factors in Overweight/Obese

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

August 2012 (undefined)

Primary Completion Date

April 2014 (Actual)

Study Completion Date

April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of North Carolina, Chapel Hill

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Purpose: The purpose of this study would be to evaluate the effects of interval training on cardiovascular health, lipid profile and body composition in overweight and obese men and women. A secondary purpose will be to compare lab based measurements of body composition [4-compartment model (4C)) with portable equipment [bioelectrical impedance spectroscopy (BIS) and ultrasound (US)] Participants: Seventy-six men and women (age 18-55 yrs; BMI 25-45 kg/m2) will be randomly assigned to a high-intensity short interval group (SIT), high-intensity long interval group (HIT) or a control group (CON). Procedures (methods): Participants will be assessed for peak oxygen utilization (VO2peak), blood lipids, glucose and insulin levels. Body composition will also be measured using a 4C model, as measured from dual energy x-ray absorptiometry (DEXA), air displacement plethysmography (BodPod), and BIS, in comparison to US values. Participants assigned to either training group will undergo 3 weeks of interval training, 3 days per week. SIT will complete 10 bouts of a series of 1 min cycling with 1 min rest periods at 90% of the power output obtained during VO2peak;in comparison HIT will complete 5 bouts of the same protocol: 2 min bouts with 1 min recovery at varying intensities of VO2peak (80-100% power output).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Metabolically Benign

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

76 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High-intensity interval -2min

Arm Type

Experimental

Arm Description

5 bouts of 2 min cycling at varying intensities of VO2peak (80-100%) with 1 min recovery.

Arm Title

High-intensity interval -1min

Arm Type

Experimental

Arm Description

10 bouts of 1 min cycling at 90% of VO2peak with 1 min rest periods

Arm Title

Control

Arm Type

No Intervention

Arm Description

No exercise

Intervention Type

Behavioral

Intervention Name(s)

Interval training

Primary Outcome Measure Information:

Title

Cardiorespiratory Fitness (VO2peak)

Time Frame

3 weeks

Secondary Outcome Measure Information:

Title

Body Composition

Time Frame

3 weeks

Title

Blood Lipids

Time Frame

3 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: written and dated informed consent to participate in the study. willing and able to comply with the protocol. good health as determined by a health and exercise status questionnaire normal electrocardiogram (ECG), and physical. body mass index of 25-45 kg/m 2. has been cleared for participation by a physician (either study or personal). Exclusion Criteria: participating in another clinical trial or have received an investigational product within thirty days prior to enrollment. has lost ten or more pounds during the previous three months and maintained the weight loss. significant history or current presence of untreated high blood pressure (BP) [systolic BP> 140 mmHg and/or diastolic BP> 90 mmHg], thyroid disease, tachyarrhythmia, heart disease, kidney disease, or liver disease. Subject currently suffers from/or has a known history of (or is currently being treated for) clinical depression or an eating disorder(s). has any medical condition or uses any medication, nutritional product, dietary supplement or program, which in the opinion of the investigator, might interfere with the conduct of the study or place the subject at risk. are identified as moderate to high risk individuals by the American College of Sports Medicine will be excluded from the study.

12. IPD Sharing Statement

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High-intensity Interval Training in Overweight/Obese

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