ObesityNCT01143376
High-intensity Intermittent Training for Obese Individuals
A study testing High intensity training, short springs and Moderate intensity exercise in people with Obesity, run by Norwegian University of Science and Technology at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- High intensity training, short springs and Moderate intensity exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteNorway
- Study dates
- May 2010to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- weight stable on the last three months,
- not currently dieting to lose weight
- inactive lifestyle.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High-intensity Intermittent Training to Maximize Metabolic and Cardiovascular Protection in 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
Read the detailed 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:
- 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).
- Conditions
- Obesity
- Being tested
- High intensity training, short springs, Moderate intensity exercise
- Keywords
- Obesity, exercise, body composition, insulin sensitivity, appetite, food intake
- Medical subject headings
- Obesity, Motor Activity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity trainingBehavioural
high-intensity intermittent sprinting (HIIS) (8 sec sprint:12 sec rest) for 12 weeks, 4 times a week
short springsBehavioural
short duration sprints (SDS)(8 sec sprint:12 sec rest) for 12 weeks, 4 times a week
Moderate intensity exerciseBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Moderate intensity exercise | Active comparator | Moderate intensity exercise Receives: Behavioral: Moderate intensity exercise |
| High Intensity training | Experimental | High Intensity intermittent training Receives: Behavioral: High intensity training |
| Short springs | Experimental | short springs training Receives: Behavioral: short springs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in body composition
Body composition assessed by DEXA
Measured: Baseline and after 12 weeks of training
Secondary outcomes (1)
Changes in insulin sensitivity
Insulin will be measured in fasting and for 3h after a test meal
Measured: Baseline and after 12 weeks of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2010 (estimated)
- Study startMay 2010
- Primary completionDec 2012
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Midt-Norge
- Responsible party
- Sponsor
- Investigators
- Catia Martins, PhD, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01143376
- Sponsor's protocol ID
- 2010/447
- Status last verified
- Apr 2017
- First submitted
- 2 Jun 2010
- Last updated
- 20 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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. Int J Sport Nutr Exerc Metab. 2016 Jun;26(3):197-204. doi: 10.1123/ijsnem.2015-0078. Epub 2015 Oct 19.
PubMed 26479856Martins 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 Sep;49(9):1851-1858. doi: 10.1249/MSS.0000000000001296.
PubMed 28398946
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-intensity Intermittent Training to Maximize Metabolic and Cardiovascular Protection in Obese Individuals
- ClinicalTrials.gov ID
- NCT01143376
- Acronym / sponsor ID
- 2010/447
- Conditions
- Obesity
- Keywords
- Obesity, exercise, body composition, insulin sensitivity, appetite, food intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Helse Midt-Norge
- Study start
- May 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 14 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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:
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Moderate intensity exercise | Active comparator | Behavioral: Moderate intensity exerciseModerate intensity exercise |
| High Intensity training | Experimental | Behavioral: High intensity trainingHigh Intensity intermittent training |
| Short springs | Experimental | Behavioral: short springsshort springs training |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- weight stable on the last three months,
- not currently dieting to lose weight
- inactive lifestyle.
Key exclusion criteria (11 listed)
- History of endocrine/cardiovascular/pulmonary/kidney disease,
- anaemia,
- gout,
- depression or other psychological disorders,
- eating disorders,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High intensity traininghigh-intensity intermittent sprinting (HIIS) (8 sec sprint:12 sec rest) for 12 weeks, 4 times a week | Behavioural | High Intensity training |
| short springsshort duration sprints (SDS)(8 sec sprint:12 sec rest) for 12 weeks, 4 times a week | Behavioural | Short springs |
| Moderate intensity exercise | Behavioural | Moderate intensity exercise |
Primary outcome
Changes in body composition
Time frame: Baseline and after 12 weeks of training
Body composition assessed by DEXA
1 secondary outcome
Changes in insulin sensitivity
Time frame: Baseline and after 12 weeks of training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2017.
- Results publication: PubMed 26479856Martins 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. Int J Sport Nutr Exerc Metab. 2016 Jun;26(3):197-204. doi: 10.1123/ijsnem.2015-0078. Epub 2015 Oct 19.
- Results publication: PubMed 28398946Martins 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 Sep;49(9):1851-1858. doi: 10.1249/MSS.0000000000001296.
Related trials for Obesity
Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation Combined With Lifestyle Intervention for Visceral Fat Reduction in Adults With Overweight or Obesity
Overweight, Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Not yet recruitingPhase 3
ELEVATE-LIVER: A Study to Test Whether Survodutide Helps Improve Heart Structure and Function in People With Overweight or Obesity and Fatty Liver Disease
Obesity, Metabolic Dysfunction-associated Steatotic Liver Disease
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catia Martins, PhD principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity training, short springs and Moderate intensity exercise in people with Obesity, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in body composition (time frame: Baseline and after 12 weeks of training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01143376, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2017.