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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01143376
Other study ID # 2010/447
Secondary ID
Status Completed
Phase N/A
First received June 2, 2010
Last updated April 19, 2017
Start date May 2010
Est. completion date January 2014

Study information

Verified date April 2017
Source Norwegian University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The most appropriate and effective exercise interventions for weight loss remain a matter of continued discussion and there is a need to identify sustainable exercise programs which successfully promote weight loss and benefit health.

The primary objective of this study is to determine if high-intensity intermittent sprinting (HIIS) produces better results in terms of reducing metabolic and cardiovascular risk factors, with special emphasis to fat mass loss and insulin sensitivity in "healthy" obese volunteers compared with an iso-caloric program of moderate-intensity continuous cycling (MICC) (control condition following the international recommendations). We will also assess the impact of short duration sprints (SDS) in the above factors and to understand the potential mechanisms behind different outcomes among training programs.

The overall hypothesis is that HIIS will lead to a greater reduction in metabolic and cardiovascular risk factors compared with MICC in healthy obese volunteers and that SDS will produce similar improvements in cardiovascular risk factors as the longer duration HIIS


Description:

Participants will be randomized to one of three groups: HIIS (8s sprint:12s rest) or MICC (control group) iso-caloric protocols (for the duration needed to induce a 250 kcal energy deficit) or SDS (8s sprint:12s rest) for 10 minutes for 12 weeks. The intervention groups will be matched for age, BMI and male/females ratio and participants will be asked not to change their normal diet throughout the study.

Before and after the exercise intervention (12 weeks), participants will perform the following assessments:

1. Three-day food diaries

2. Anthropometric measurements (weight, height, waist and hips) using standard procedures;

3. Body composition using dual energy x-ray absorptiometry (DEXA)

4. RMR and resting respiratory exchange ratio (RER) using indirect calorimetry;

5. Endothelial function assessed by flow-mediated dilation (FMD) of the brachial artery using vascular ultrasound according to current guidelines;

6. Maximal oxygen uptake (VO2max) and fat oxidation, cardiac output and left ventricular function during exercise using a cycle ergometer;

7. Muscle and fat biopsies

8. Fasting and postprandial release of appetite related hormones (and subjective feelings of hunger/fullness using visual analogue scales - VAS).


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date January 2014
Est. primary completion date December 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- weight stable on the last three months,

- not currently dieting to lose weight

- inactive lifestyle.

Exclusion Criteria:

- History of endocrine/cardiovascular/pulmonary/kidney disease,

- anaemia,

- gout,

- depression or other psychological disorders,

- eating disorders,

- drug or alcohol abuse within the last two years

- current medication known to affect appetite or induce weight loss.

- planned surgery during the study period

- participation in another research study

- restraint score derived from the TFEQ>12

- post-menopausal women

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
High intensity training
high-intensity intermittent sprinting (HIIS) (8 sec sprint:12 sec rest) for 12 weeks, 4 times a week
short springs
short duration sprints (SDS)(8 sec sprint:12 sec rest) for 12 weeks, 4 times a week
Moderate intensity exercise


Locations

Country Name City State
Norway Norwegian University of Science and Technology Trondheim

Sponsors (2)

Lead Sponsor Collaborator
Norwegian University of Science and Technology Helse Midt-Norge

Country where clinical trial is conducted

Norway, 

References & Publications (2)

Martins C, Aschehoug I, Ludviksen M, Holst J, Finlayson G, Wisloff U, Morgan L, King N, Kulseng B. High-Intensity Interval Training, Appetite, and Reward Value of Food in the Obese. Med Sci Sports Exerc. 2017 Apr 11. doi: 10.1249/MSS.0000000000001296. [Ep — View Citation

Martins C, Kazakova I, Ludviksen M, Mehus I, Wisloff U, Kulseng B, Morgan L, King N. High-Intensity Interval Training and Isocaloric Moderate-Intensity Continuous Training Result in Similar Improvements in Body Composition and Fitness in Obese Individuals — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in body composition Body composition assessed by DEXA Baseline and after 12 weeks of training
Secondary Changes in insulin sensitivity Insulin will be measured in fasting and for 3h after a test meal Baseline and after 12 weeks of training
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