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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02444377
Other study ID # 12-1026
Secondary ID
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


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
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