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Completed

NCT Number: NCT01143376

High-intensity Intermittent Training for Obese Individuals

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

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Key information

Conditions

Obesity Behavior Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Norwegian University of Science and Technology

Trondheim, 7489, Norway

About this study

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:

  • Three-day food diaries
  • Anthropometric measurements (weight, height, waist and hips) using standard procedures;
  • Body composition using dual energy x-ray absorptiometry (DEXA)
  • RMR and resting respiratory exchange ratio (RER) using indirect calorimetry;
  • Endothelial function assessed by flow-mediated dilation (FMD) of the brachial artery using vascular ultrasound according to current guidelines;
  • Maximal oxygen uptake (VO2max) and fat oxidation, cardiac output and left ventricular function during exercise using a cycle ergometer;
  • Muscle and fat biopsies
  • Fasting and postprandial release of appetite related hormones (and subjective feelings of hunger/fullness using visual analogue scales - VAS).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Intensity Training

Behavioral

high-intensity intermittent sprinting (HIIS) (8 sec sprint:12 sec rest) for 12 weeks, 4 times a week

short springs

Behavioral

short duration sprints (SDS)(8 sec sprint:12 sec rest) for 12 weeks, 4 times a week

Moderate Intensity Exercise

Behavioral

Primary outcomes

  1. Changes in body composition

    Time frame: Baseline and after 12 weeks of training

    Body composition assessed by DEXA

Secondary outcomes

  1. Changes in insulin sensitivity

    Time frame: Baseline and after 12 weeks of training

    Insulin will be measured in fasting and for 3h after a test meal

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Helse Midt-Norge

Registry information

Official study title

High-intensity Intermittent Training to Maximize Metabolic and Cardiovascular Protection in Obese Individuals

Important dates

Study start
2010
Primary completion
2012
Study completion
2014
First posted
Jun 14, 2010
Registry last updated
Apr 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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