Clinical trial NCT02254200: Exercise Training and Fitness in Severe Obesity
Official title: Effect of Short-term High-intensity Interval and Fatmax Training on Aerobic and Metabolic Fitness in Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: exercise
fat oxidation
indirect calorimetry
insulin sensitivity
weight management
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
Collaborators: name: University of Lausanne
First posted: 2014-10-01
Enrollment: 19
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 \[Body Mass Index (BMI): \> 40 kg\*m-2\]. 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.

Eligibility criteria: Inclusion Criteria:

* BMI ≥ 35 kg\*m-2

Exclusion Criteria:

* Hypertension (blood pressure \> 130/90)
* Impaired fasting glucose (\> 6.1 mmol\*L-1)
* Type 2 diabetes
* Abnormal ECG readings at rest

Primary outcomes:
measure: Maximal Oxygen consumption (VO2 max)
timeFrame: After two-wk-long of Fatmax or HIIT traning
measure: Fat oxidation rates (FORs)
timeFrame: After two-wk-long of Fatmax or HIIT traning
Secondary outcomes:
measure: HOMA-IR
timeFrame: After two-wk-long of Fatmax or HIIT traning
measure: Non-esterified fatty acid (NEFA)
timeFrame: After two-wk-long of Fatmax or HIIT traning
measure: Insulin
timeFrame: After two-wk-long of Fatmax or HIIT traning
Other outcomes:
Locations:
city: Verbania
country: Italy
facility: Istituto Auxologico Italiano, Ospedale San Giuseppe
state: VB
Study officials:
affiliation: University of Lausanne, Department of Physiology
name: Stefano Lanzi, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Istituto Auxologico Italiano, Pulmonary Rehabilitation Department
name: Alberto Salvadori, MD
role: STUDY_DIRECTOR
affiliation: Istituto Auxologico Italiano, Pulmonary Rehabilitation Department
name: Franco Codecasa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Istituto Auxologico Italiano, Pulmonary Rehabilitation Department
name: Mauro Cornacchia, MD
role: STUDY_CHAIR
affiliation: University of Lausanne, Institute of Sport Sciences
name: Davide Malatesta, PhD
role: STUDY_DIRECTOR
affiliation: Istituto Auxologico Italiano, Pulmonary Rehabilitation Department
name: Paolo Fanari, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: Houmard 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.
citation: Dumortier 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.
citation: Bordenave 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.
citation: Burgomaster 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.
citation: Whyte 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.
citation: Trilk 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.
citation: Lanzi 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.