High Intensity Interval Versus Continuous Moderate Intensity Training: Maximizing the Benefits of Exercise in Overweight Adolescents

Metabolism Clinical Trial

— HIIT-MAX  

Official title:

High Intensity Interval Versus Continuous Moderate Intensity Training: Maximizing the Benefits of Exercise in Overweight Adolescents.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01935323
• Other study ID #: F121101004
• Status: Completed
• Phase: N/A
• First received: June 20, 2013
• Last updated: January 8, 2016
• Start date: February 2013
• Est. completion date: December 2014

Study information

• Verified date: January 2016
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

6-week, single site, two parallel arm, randomized, controlled trial comparing the effectiveness of a High Intensity Interval Training (HIIT) versus a continuous Moderate Intensity Training (MIT) program on cardiovascular and metabolic health outcomes in overweight adolescent males. HIIT training may be a potent time-efficient strategy to induce similar metabolic and cardiovascular adaptations typically associated with MIT.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 17 Years to 22 Years

Eligibility

Inclusion Criteria:

• Ages 17-22

• Men

• BMI (25.0 - 35.0 kg/m2)

• Interested in improving health and fitness

Exclusion Criteria:

• Weight loss or gain of >10% of body weight in the past 6 months for any reason.

• Currently taking medication that suppresses or stimulates appetite.

• History of prior surgical procedure for weight control or liposuction.

• Current smoker.

Any major disease, including:

• Active cancer or cancer requiring treatment in the past 2 years (except nonmelanoma skin cancer).

• Active or chronic infections, including self-reported HIV positivity and active tuberculosis.

• Diagnosed heart conditions.

• Uncontrolled hypertension: systolic blood pressure 160 mm Hg or diastolic blood pressure 95 mm Hg on treatment.

• Gastrointestinal disease, including self-reported chronic hepatitis or cirrhosis, any episode of alcoholic hepatitis or alcoholic pancreatitis within past year, inflammatory bowel disease requiring treatment in the past year, recent or significant abdominal surgery (e.g., gastrectomy).

• Asthma.

• Diagnosed diabetes (type 1 or 2), fasting impaired glucose tolerance (blood glucose 118 mg/dL), or use of any anti-diabetic medications.

• Conditions or behaviors likely to effect the conduct of the trial: unable or unwilling to give informed consent; unable to communicate with the pertinent clinic staff; unwilling to accept treatment assignment by randomization; current or anticipated participation in another intervention research project that would interfere with the intervention offered in the trial; likely to move away from participating clinics before trial completed; unable to walk 0.25 mile in 10 minutes.

• Currently taking antidepressant, steroid, or thyroid medication, unless dosage is stable (no change for 6 months).

• Any active use of illegal or illicit drugs.

• Excessive alcohol intake defined as an average consumption of 3 or more alcohol containing beverages daily.

• Unwilling to limit alcohol intake to =2 drink per day (one drink = 4 oz. wine, 12 oz. beer, or ½ shot of liquor).

• Current exerciser (>30 min organized exercise per week).

• Indication of unsuitability of current health for exercise protocol (PARQ).

• Any other conditions which, in opinion of the investigators, would adversely affect the conduct of the trial.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Metabolism
• Physical Fitness

Intervention

Other:
• High Intensity Interval Training

• Moderate Intensity Training

Locations

Country	Name	City	State
United States	UAB Physiology Lab	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	The Coca-Cola Company

Country where clinical trial is conducted

United States, 

References & Publications (1)

Fisher G, Brown AW, Bohan Brown MM, Alcorn A, Noles C, Winwood L, Resuehr H, George B, Jeansonne MM, Allison DB. High Intensity Interval- vs Moderate Intensity- Training for Improving Cardiometabolic Health in Overweight or Obese Males: A Randomized Controlled Trial. PLoS One. 2015 Oct 21;10(10):e0138853. doi: 10.1371/journal.pone.0138853. eCollection 2015. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Composition as measured by DXA		Baseline and 6 weeks	No
Secondary	Body Weight		Baseline and 6 weeks	No
Secondary	Blood Pressure		Baseline and 6 weeks	No
Secondary	Body Mass Index		Baseline and 6 weeks	No
Secondary	Peak uptake of volume of oxygen		Baseline and 6 weeks	No
Secondary	Wingate Cycle test		Baseline and 6 weeks	No
Secondary	LDL Cholesterol		Baseline and 6 weeks	No
Secondary	HDL Cholesterol		Baseline and 6 weeks	No
Secondary	Triglycerides		Baseline and 6 weeks	No
Secondary	Glucose		Baseline and 6 weeks	No
Secondary	Insulin		Baseline and 6 weeks	No
Secondary	Ghrelin		Baseline and 6 weeks	No
Secondary	Leptin		Baseline and 6 weeks	No
Secondary	Adiponectin		Baseline and 6 weeks	No
Secondary	PYY		Baseline and 6 weeks	No
Secondary	IL-6		Baseline and 6 weeks	No
Secondary	TNF-alpha		Baseline and 6 weeks	No
Secondary	Total antioxidant capacity		Baseline and 6 weeks	No
Secondary	Protein Carbonyls	ELISA assay purchased from NW LifeSciences. Prior to analysis, all serum samples were assayed for protein concentration based on the methods of Bradford and adjusted to 4 mg·mL-1 protein using a phosphate buffer. Protein carbonyls, a measure of protein oxidation, were analyzed in duplicate in 50 µl of sera using a commercially available ELISA kit (NWK-PCK01).The intra- and interassay coefficients of variation were 2.7 % and 5%. The lower detection limit of the assay was 0.1 nmol/mg.	Baseline and 6 weeks	No
Secondary	Free living energy expenditure as measured by accelerometer		Baseline and 6 weeks	No
Secondary	Appetite/satiety measures	composite score	baseline & 6 weeks	No
Secondary	Quality & satisfaction with life	composite score	baseline & 6 weeks	No
Secondary	Rate of perceived exertion during exercise via Borg Scale		baseline and 6 weeks	No
Secondary	24-hour dietary recall		pre-baseline, baseline, 6 weeks	No
Secondary	Self Motivation Inventory		baseline and 6 weeks	No
Secondary	Profile of Mood States		baseline & 6 weeks	No

External Links

•   UAB Nutrition Obesity Research Center