Exercise Training and Fitness in Severe Obesity (INTFMOBE)

July 20, 2015 updated by: Istituto Auxologico Italiano

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • VB
      • Verbania, VB, Italy, 28921
        • Istituto Auxologico Italiano, Ospedale San Giuseppe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fatmax group
Group who performed a continuous training program at the intensity eliciting the maximal fat oxidation
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)
Experimental: HIIT group
Group who performed a continuous training program with high intensity interval
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
After two-wk-long of Fatmax or HIIT traning
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
After two-wk-long of Fatmax or HIIT traning

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HOMA-IR
Time Frame: After two-wk-long of Fatmax or HIIT traning
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
Non-esterified fatty acid (NEFA)
Time Frame: After two-wk-long of Fatmax or HIIT traning
Resting NEFA at the end of Fatmax or HIIT training period
After two-wk-long of Fatmax or HIIT traning
Insulin
Time Frame: After two-wk-long of Fatmax or HIIT traning
Resting Insulin at the end of Fatmax or HIIT training period
After two-wk-long of Fatmax or HIIT traning

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Auxologico Italiano

Collaborators

University of Lausanne

Investigators

  • Principal Investigator: Stefano Lanzi, MSc, University of Lausanne, Department of Physiology
  • Study Director: Alberto Salvadori, MD, Istituto Auxologico Italiano, Pulmonary Rehabilitation Department
  • Principal Investigator: Franco Codecasa, MD, Istituto Auxologico Italiano, Pulmonary Rehabilitation Department
  • Study Chair: Mauro Cornacchia, MD, Istituto Auxologico Italiano, Pulmonary Rehabilitation Department
  • Study Director: Davide Malatesta, PhD, University of Lausanne, Institute of Sport Sciences
  • Study Chair: Paolo Fanari, MD, Istituto Auxologico Italiano, Pulmonary Rehabilitation Department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

September 29, 2014

First Submitted That Met QC Criteria

September 29, 2014

First Posted (Estimate)

October 1, 2014

Study Record Updates

Last Update Posted (Estimate)

July 21, 2015

Last Update Submitted That Met QC Criteria

July 20, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06C301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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