ObesityINTFMOBENCT02254200
Exercise Training and Fitness in Severe Obesity
A study testing Fatmax group and HIIT group in people with Obesity, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial summary
Obesity is commonly associated with insulin resistance and hyperinsulinemia, which seem to be linked with an impaired ability to oxidize lipids, particularly in class III obese individuals [Body Mass Index (BMI): > 40 kg*m-2]. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Fatmax group and HIIT group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2013to 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI ≥ 35 kg*m-2
Who cannot join
- Hypertension (blood pressure > 130/90)
- Impaired fasting glucose (> 6.1 mmol*L-1)
- Type 2 diabetes
- Abnormal ECG readings at rest
Trial locations and contacts
1 site in 1 country.
Italy1 site
Istituto Auxologico Italiano, Ospedale San Giuseppe
Verbania, VB, 28921
About this study
Official title: Effect of Short-term High-intensity Interval and Fatmax Training on Aerobic and Metabolic Fitness in Obese Subjects
Obesity is commonly associated with insulin resistance and hyperinsulinemia, which seem to be linked with an impaired ability to oxidize lipids, particularly in class III obese individuals [Body Mass Index (BMI): > 40 kg*m-2]. Exercise training is an effective strategy to improve insulin sensitivity and to reduce the risk of type 2 diabetes.
This study aimed to compare the effects of two different 2-wk-long training modalities [continuous at the intensity eliciting the maximal fat oxidation (Fatmax) versus adapted high intensity interval training (HIIT)] on aerobic and metabolic fitness of class II and III obese men. It was hypothesized that, because of the nature of HIIT in the stimulation of rapid changes, aerobic fitness, fat oxidation rates during exercise and insulin sensitivity would be improved to a greater extent when adapted HIIT compared to Fatmax training.
Read the detailed description
Obesity is commonly associated with insulin resistance and hyperinsulinemia, which seem to be linked with an impaired ability to oxidize lipids, particularly in class III obese individuals [Body Mass Index (BMI): > 40 kg*m-2] (1). Exercise training is an effective strategy to improve insulin sensitivity and to reduce the risk of type 2 diabetes (2). It has been suggested that 8 (3) or 10 wk (4) of an individualized moderate exercise training program at intensity (Fatmax) that elicits maximal fat oxidation (MFO) may significantly increase the fat oxidation rates (FORs) during exercise; it may also increase the muscle oxidative capacity in overweight and class I obese men. The effects of an individualized Fatmax training program of a shorter duration have never been investigated.
High-intensity interval training (Wingate-based HIIT) has been shown to induce similar adaptations as traditional training at a moderate intensity following 6 wk of training in healthy adults despite the lower training volume (5). This suggests that HIIT may be a time-efficient alternative (6). Recently, HIIT was also reported to rapidly induce adaptations that are linked to improved health-related outcomes in sedentary and overweight/obese individuals (7, 8).
This study aimed to compare the effects of two different 2-wk-long training modalities [continuous at the intensity eliciting the maximal fat oxidation (Fatmax) versus adapted high intensity interval training (HIIT)] on aerobic and metabolic fitness of class II and III obese men. It was hypothesized that, because of the nature of HIIT in the stimulation of rapid changes, aerobic fitness, fat oxidation rates during exercise and insulin sensitivity would be improved to a greater extent when trained with adapted HIIT compared to Fatmax training.
A group of twenty obese men (BMI≥35 kg*m-2) will be assigned to Fatmax group or to adapted HIIT group. Both groups will perform 8 cycling-sessions matched for mechanical work spread over 14 days [40-50 min continuous exercise at ~60-70% of the maximal heart rate (Fatmax) or 10x60-s cycling intervals a ~90% maximal heart rate interspersed with 60-s recovery (HIIT)]. Aerobic fitness and fat oxidation rates (FORs) during exercise will be assessed prior to and following the training with a maximal incremental test. Blood samples will also be drawn to determine hormones and plasma metabolites levels. Insulin sensitivity was assessed by the homeostasis model assessment of insulin resistance (HOMA).
The experimental design will consist of the following: 1) maximal ramp incremental test, to determine peak power output of each subject. 2) pre training test with blood samples, maximal incremental test (Incr) to determine the whole-body fat oxidation kinetics and Fatmax in the first phase (IncrP1) and the maximal parameters in the second phase (IncrP2) of the test. 3) 2-wk training intervention, Fatmax or HIIT and 4) post-training test, control maximal incremental test with blood samples.
A 3-way repeated-measures ANOVA (time x group x exercise intensity) will be performed to compare the investigated variables.
- Conditions
- Obesity
- Being tested
- Fatmax group, HIIT group
- Keywords
- exercise, fat oxidation, indirect calorimetry, insulin sensitivity, weight management
- 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.
Fatmax groupOther
For the Fatmax group each session will consist of 40-50 min of continuous exercise with an intensity that corresponded to the individual Fatmax (moderate intensity)
HIIT groupOther
For HIIT group, each session will consist of 10x60-s cycling intervals interspersed with 60-s of recovery. The workloads will be selected to elicit a heart rate of ~90% maximal heart rate during the intervals with a pedal rate of 90-100 revolutions.min-1, whereas during recovery, the participants will be allowed to pedal against a resistance of 50 W
| Study group | Role | What they receive |
|---|---|---|
| Fatmax group | Experimental | Group who performed a continuous training program at the intensity eliciting the maximal fat oxidation Receives: Other: Fatmax group |
| HIIT group | Experimental | Group who performed a continuous training program with high intensity interval Receives: Other: HIIT group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Oxygen consumption (VO2 max)
VO2 max at incremental test performed at the end of Fatmax or HIIT training period
Measured: After two-wk-long of Fatmax or HIIT traning
Fat oxidation rates (FORs)
FORs at incremental test performed at the end of Fatmax or HIIT training period
Measured: After two-wk-long of Fatmax or HIIT traning
Secondary outcomes (3)
HOMA-IR
Insulin sensitivity assessed by homeostasis model assessment of insulin resistance (HOMA-IR) at the end of Fatmax or HIIT training period
Measured: After two-wk-long of Fatmax or HIIT traning
Non-esterified fatty acid (NEFA)
Resting NEFA at the end of Fatmax or HIIT training period
Measured: After two-wk-long of Fatmax or HIIT traning
Insulin
Resting Insulin at the end of Fatmax or HIIT training period
Measured: After two-wk-long of Fatmax or HIIT traning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study startJan 2013
- Primary completionDec 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- 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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lausanne
- Responsible party
- Sponsor
- Investigators
- Stefano Lanzi, MSc, Principal investigator, University of Lausanne, Department of PhysiologyAlberto Salvadori, MD, Study director, Istituto Auxologico Italiano, Pulmonary Rehabilitation DepartmentFranco Codecasa, MD, Principal investigator, Istituto Auxologico Italiano, Pulmonary Rehabilitation DepartmentMauro Cornacchia, MD, Study chair, Istituto Auxologico Italiano, Pulmonary Rehabilitation DepartmentDavide Malatesta, PhD, Study director, University of Lausanne, Institute of Sport SciencesPaolo Fanari, MD, Study chair, Istituto Auxologico Italiano, Pulmonary Rehabilitation Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02254200
- Sponsor's protocol ID
- 06C301
- Acronym
- INTFMOBE
- Status last verified
- Jul 2015
- First submitted
- 29 Sep 2014
- Last updated
- 21 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Houmard JA. Intramuscular lipid oxidation and obesity. Am J Physiol Regul Integr Comp Physiol. 2008 Apr;294(4):R1111-6. doi: 10.1152/ajpregu.00396.2007. Epub 2008 Feb 6.
PubMed 18256136Houmard JA, Tanner CJ, Slentz CA, Duscha BD, McCartney JS, Kraus WE. Effect of the volume and intensity of exercise training on insulin sensitivity. J Appl Physiol (1985). 2004 Jan;96(1):101-6. doi: 10.1152/japplphysiol.00707.2003. Epub 2003 Sep 12.
PubMed 12972442Dumortier M, Brandou F, Perez-Martin A, Fedou C, Mercier J, Brun JF. Low intensity endurance exercise targeted for lipid oxidation improves body composition and insulin sensitivity in patients with the metabolic syndrome. Diabetes Metab. 2003 Nov;29(5):509-18. doi: 10.1016/s1262-3636(07)70065-4.
PubMed 14631328Bordenave S, Metz L, Flavier S, Lambert K, Ghanassia E, Dupuy AM, Michel F, Puech-Cathala AM, Raynaud E, Brun JF, Mercier J. Training-induced improvement in lipid oxidation in type 2 diabetes mellitus is related to alterations in muscle mitochondrial activity. Effect of endurance training in type 2 diabetes. Diabetes Metab. 2008 Apr;34(2):162-8. doi: 10.1016/j.diabet.2007.11.006.
PubMed 18396088Burgomaster KA, Howarth KR, Phillips SM, Rakobowchuk M, Macdonald MJ, McGee SL, Gibala MJ. Similar metabolic adaptations during exercise after low volume sprint interval and traditional endurance training in humans. J Physiol. 2008 Jan 1;586(1):151-60. doi: 10.1113/jphysiol.2007.142109. Epub 2007 Nov 8.
PubMed 17991697Whyte LJ, Gill JM, Cathcart AJ. Effect of 2 weeks of sprint interval training on health-related outcomes in sedentary overweight/obese men. Metabolism. 2010 Oct;59(10):1421-8. doi: 10.1016/j.metabol.2010.01.002. Epub 2010 Feb 12.
PubMed 20153487Trilk JL, Singhal A, Bigelman KA, Cureton KJ. Effect of sprint interval training on circulatory function during exercise in sedentary, overweight/obese women. Eur J Appl Physiol. 2011 Aug;111(8):1591-7. doi: 10.1007/s00421-010-1777-z. Epub 2010 Dec 29.
PubMed 21190036Lanzi S, Codecasa F, Cornacchia M, Maestrini S, Capodaglio P, Brunani A, Fanari P, Salvadori A, Malatesta D. Short-term HIIT and Fat max training increase aerobic and metabolic fitness in men with class II and III obesity. Obesity (Silver Spring). 2015 Oct;23(10):1987-94. doi: 10.1002/oby.21206. Epub 2015 Sep 3.
PubMed 26335027
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Short-term High-intensity Interval and Fatmax Training on Aerobic and Metabolic Fitness in Obese Subjects
- ClinicalTrials.gov ID
- NCT02254200
- Acronym / sponsor ID
- INTFMOBE / 06C301
- Conditions
- Obesity
- Keywords
- exercise, fat oxidation, indirect calorimetry, insulin sensitivity, weight management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Collaborators
- University of Lausanne
- Study start
- Jan 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 1 Oct 2014 (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.
Obesity is commonly associated with insulin resistance and hyperinsulinemia, which seem to be linked with an impaired ability to oxidize lipids, particularly in class III obese individuals [Body Mass Index (BMI): > 40 kg*m-2]. Exercise training is an effective strategy to improve insulin sensitivity and to reduce the risk of type 2 diabetes.
This study aimed to compare the effects of two different 2-wk-long training modalities [continuous at the intensity eliciting the maximal fat oxidation (Fatmax) versus adapted high intensity interval training (HIIT)] on aerobic and metabolic fitness of class II and III obese men. It was hypothesized that, because of the nature of HIIT in the stimulation of rapid changes, aerobic fitness, fat oxidation rates during exercise and insulin sensitivity would be improved to a greater extent when adapted HIIT compared to Fatmax training.
Detailed description
Obesity is commonly associated with insulin resistance and hyperinsulinemia, which seem to be linked with an impaired ability to oxidize lipids, particularly in class III obese individuals [Body Mass Index (BMI): > 40 kg*m-2] (1). Exercise training is an effective strategy to improve insulin sensitivity and to reduce the risk of type 2 diabetes (2). It has been suggested that 8 (3) or 10 wk (4) of an individualized moderate exercise training program at intensity (Fatmax) that elicits maximal fat oxidation (MFO) may significantly increase the fat oxidation rates (FORs) during exercise; it may also increase the muscle oxidative capacity in overweight and class I obese men. The effects of an individualized Fatmax training program of a shorter duration have never been investigated.
High-intensity interval training (Wingate-based HIIT) has been shown to induce similar adaptations as traditional training at a moderate intensity following 6 wk of training in healthy adults despite the lower training volume (5). This suggests that HIIT may be a time-efficient alternative (6). Recently, HIIT was also reported to rapidly induce adaptations that are linked to improved health-related outcomes in sedentary and overweight/obese individuals (7, 8).
This study aimed to compare the effects of two different 2-wk-long training modalities [continuous at the intensity eliciting the maximal fat oxidation (Fatmax) versus adapted high intensity interval training (HIIT)] on aerobic and metabolic fitness of class II and III obese men. It was hypothesized that, because of the nature of HIIT in the stimulation of rapid changes, aerobic fitness, fat oxidation rates during exercise and insulin sensitivity would be improved to a greater extent when trained with adapted HIIT compared to Fatmax training.
A group of twenty obese men (BMI≥35 kg*m-2) will be assigned to Fatmax group or to adapted HIIT group. Both groups will perform 8 cycling-sessions matched for mechanical work spread over 14 days [40-50 min continuous exercise at ~60-70% of the maximal heart rate (Fatmax) or 10x60-s cycling intervals a ~90% maximal heart rate interspersed with 60-s recovery (HIIT)]. Aerobic fitness and fat oxidation rates (FORs) during exercise will be assessed prior to and following the training with a maximal incremental test. Blood samples will also be drawn to determine hormones and plasma metabolites levels. Insulin sensitivity was assessed by the homeostasis model assessment of insulin resistance (HOMA).
The experimental design will consist of the following: 1) maximal ramp incremental test, to determine peak power output of each subject. 2) pre training test with blood samples, maximal incremental test (Incr) to determine the whole-body fat oxidation kinetics and Fatmax in the first phase (IncrP1) and the maximal parameters in the second phase (IncrP2) of the test. 3) 2-wk training intervention, Fatmax or HIIT and 4) post-training test, control maximal incremental test with blood samples.
A 3-way repeated-measures ANOVA (time x group x exercise intensity) will be performed to compare the investigated variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fatmax group | Experimental | Other: Fatmax groupGroup who performed a continuous training program at the intensity eliciting the maximal fat oxidation |
| HIIT group | Experimental | Other: HIIT groupGroup who performed a continuous training program with high intensity interval |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI ≥ 35 kg*m-2
Key exclusion criteria (4 listed)
- Hypertension (blood pressure > 130/90)
- Impaired fasting glucose (> 6.1 mmol*L-1)
- Type 2 diabetes
- Abnormal ECG readings at rest
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 |
|---|---|---|
| Fatmax groupFor the Fatmax group each session will consist of 40-50 min of continuous exercise with an intensity that corresponded to the individual Fatmax (moderate intensity) | Other | Fatmax group |
| HIIT groupFor HIIT group, each session will consist of 10x60-s cycling intervals interspersed with 60-s of recovery. The workloads will be selected to elicit a heart rate of ~90% maximal heart rate during the intervals with a pedal rate of 90-100 revolutions.min-1, whereas during recovery, the participants will be allowed to pedal against a resistance of 50 W | Other | HIIT group |
Primary outcome
Maximal Oxygen consumption (VO2 max)
Time frame: After two-wk-long of Fatmax or HIIT traning
VO2 max at incremental test performed at the end of Fatmax or HIIT training period
Fat oxidation rates (FORs)
Time frame: After two-wk-long of Fatmax or HIIT traning
FORs at incremental test performed at the end of Fatmax or HIIT training period
3 secondary outcomes
HOMA-IR
Time frame: After two-wk-long of Fatmax or HIIT traning
Non-esterified fatty acid (NEFA)
Time frame: After two-wk-long of Fatmax or HIIT traning
Insulin
Time frame: After two-wk-long of Fatmax or HIIT traning
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 21 Jul 2015.
- Background: PubMed 18256136Houmard JA. Intramuscular lipid oxidation and obesity. Am J Physiol Regul Integr Comp Physiol. 2008 Apr;294(4):R1111-6. doi: 10.1152/ajpregu.00396.2007. Epub 2008 Feb 6.
- Background: PubMed 12972442Houmard JA, Tanner CJ, Slentz CA, Duscha BD, McCartney JS, Kraus WE. Effect of the volume and intensity of exercise training on insulin sensitivity. J Appl Physiol (1985). 2004 Jan;96(1):101-6. doi: 10.1152/japplphysiol.00707.2003. Epub 2003 Sep 12.
- Background: PubMed 14631328Dumortier M, Brandou F, Perez-Martin A, Fedou C, Mercier J, Brun JF. Low intensity endurance exercise targeted for lipid oxidation improves body composition and insulin sensitivity in patients with the metabolic syndrome. Diabetes Metab. 2003 Nov;29(5):509-18. doi: 10.1016/s1262-3636(07)70065-4.
- Background: PubMed 18396088Bordenave S, Metz L, Flavier S, Lambert K, Ghanassia E, Dupuy AM, Michel F, Puech-Cathala AM, Raynaud E, Brun JF, Mercier J. Training-induced improvement in lipid oxidation in type 2 diabetes mellitus is related to alterations in muscle mitochondrial activity. Effect of endurance training in type 2 diabetes. Diabetes Metab. 2008 Apr;34(2):162-8. doi: 10.1016/j.diabet.2007.11.006.
- Background: PubMed 17991697Burgomaster KA, Howarth KR, Phillips SM, Rakobowchuk M, Macdonald MJ, McGee SL, Gibala MJ. Similar metabolic adaptations during exercise after low volume sprint interval and traditional endurance training in humans. J Physiol. 2008 Jan 1;586(1):151-60. doi: 10.1113/jphysiol.2007.142109. Epub 2007 Nov 8.
- Background: PubMed 20153487Whyte LJ, Gill JM, Cathcart AJ. Effect of 2 weeks of sprint interval training on health-related outcomes in sedentary overweight/obese men. Metabolism. 2010 Oct;59(10):1421-8. doi: 10.1016/j.metabol.2010.01.002. Epub 2010 Feb 12.
- Background: PubMed 21190036Trilk JL, Singhal A, Bigelman KA, Cureton KJ. Effect of sprint interval training on circulatory function during exercise in sedentary, overweight/obese women. Eur J Appl Physiol. 2011 Aug;111(8):1591-7. doi: 10.1007/s00421-010-1777-z. Epub 2010 Dec 29.
- Derived from this study: PubMed 26335027Lanzi S, Codecasa F, Cornacchia M, Maestrini S, Capodaglio P, Brunani A, Fanari P, Salvadori A, Malatesta D. Short-term HIIT and Fat max training increase aerobic and metabolic fitness in men with class II and III obesity. Obesity (Silver Spring). 2015 Oct;23(10):1987-94. doi: 10.1002/oby.21206. Epub 2015 Sep 3.
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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.
Stefano Lanzi, MSc principal investigator
University of Lausanne, Department of Physiology
Alberto Salvadori, MD study director
Istituto Auxologico Italiano, Pulmonary Rehabilitation Department
Franco Codecasa, MD principal investigator
Istituto Auxologico Italiano, Pulmonary Rehabilitation Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fatmax group and HIIT group in people with Obesity, run by Istituto Auxologico Italiano at 1 site in Italy.
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 1 inclusion and 4 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 21 Jul 2015. 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 Italy. 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?
Maximal Oxygen consumption (VO2 max) (time frame: After two-wk-long of Fatmax or HIIT traning). The study lists 2 primary outcomes in all. 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 NCT02254200, which also lists 8 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 21 Jul 2015.