Exercise Training and Fitness in Severe Obesity

Obesity Clinical Trial

— INTFMOBE  

Official title:

Effect of Short-term High-intensity Interval and Fatmax Training on Aerobic and Metabolic Fitness in Obese Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02254200
• Other study ID #: 06C301
• Status: Completed
• Phase: N/A
• First received: September 29, 2014
• Last updated: July 20, 2015
• Start date: January 2013
• Est. completion date: January 2014

Study information

• Verified date: July 2015
• Source: Istituto Auxologico Italiano
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical 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]. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• Fatmax group
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 group
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

Locations

Country	Name	City	State
Italy	Istituto Auxologico Italiano, Ospedale San Giuseppe	Verbania	VB

Sponsors (2)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano	University of Lausanne

Country where clinical trial is conducted

Italy, 

References & Publications (7)

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. — View 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. Epub 2007 Nov 8. — View 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. — View 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. Epub 2003 Sep 12. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal Oxygen consumption (VO2 max)	VO2 max at incremental test performed at the end of Fatmax or HIIT training period	After two-wk-long of Fatmax or HIIT traning	No
Primary	Fat oxidation rates (FORs)	FORs at incremental test performed at the end of Fatmax or HIIT training period	After two-wk-long of Fatmax or HIIT traning	No
Secondary	HOMA-IR	Insulin sensitivity assessed by homeostasis model assessment of insulin resistance (HOMA-IR) at the end of Fatmax or HIIT training period	After two-wk-long of Fatmax or HIIT traning	No
Secondary	Non-esterified fatty acid (NEFA)	Resting NEFA at the end of Fatmax or HIIT training period	After two-wk-long of Fatmax or HIIT traning	No
Secondary	Insulin	Resting Insulin at the end of Fatmax or HIIT training period	After two-wk-long of Fatmax or HIIT traning	No