High-intensity Interval Training in Overweight/Obese

Obesity, Metabolically Benign Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02444377
• Other study ID #: 12-1026
• Status: Completed
• Phase: N/A
• First received: May 11, 2015
• Last updated: November 29, 2016
• Start date: August 2012
• Est. completion date: April 2014

Study information

• Verified date: May 2015
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity, Metabolically Benign
• Overweight

Intervention

Behavioral:
• Interval training

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiorespiratory Fitness (VO2peak)		3 weeks	No
Secondary	Body Composition		3 weeks	No
Secondary	Blood Lipids		3 weeks	No