Acute and Chronic Metabolic Flexibility in Individuals Living With Obesity: The i-FLEX Study (i-FLEX)

March 24, 2020 updated by: Martin Senechal, University of New Brunswick

Sprint Interval Training: Insulin Sensitivity and Acute-Chronic Metabolic Flexibility in Individuals Living With Obesity: The i-FLEX Study

Regular exercise is a cornerstone in the prevention and the management of cardio-metabolic risk factors. Some of the beneficial effect of exercise training occurs through metabolic flexibility' enhancement. Metabolic flexibility is the ability to respond or adapt to conditional changes in metabolic demand, and previous literature has shown that individuals living with obesity have an impaired metabolic flexibility compared to lean individuals. However, there is a lack of empirical evidence on the impact of sprint interval training on metabolic flexibility and whether this translates into clinically meaningful outcomes.

This study will evaluate the impact of 4-week sprint interval training in normal weight individuals as well as individuals living with obesity on acute and chronic metabolic flexibility, irisin secretion and insulin sensitivity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

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

  • Canada
    • New Brunswick
      • Fredericton, New Brunswick, Canada, E3B 5A3
        • University of New Brunswick - Kinesiology

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

19 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults (Ages 19-60)
  • Physically inactive for individuals living with obesity (not meeting Canadian Physical Activity Guidelines)
  • Normal Weight (BMI ≥ 18.5 < 25.0 km/m2)
  • Obesity (BMI ≥ 30.0 km/m2)

Exclusion Criteria:

  • Individuals with Type 2 Diabetes.
  • Individuals with impaired glucose tolerance.
  • Individuals living with obesity that partake in regular exercise training / meet the Canadian Physical Activity Guidelines.
  • Individuals with a condition or injury that may impact the ability to perform exercise or may be worsened by exercise.
  • Individuals currently being treated with corticosteroids or atypical antipsychotics, as these agents significantly influence carbohydrate metabolism.
  • have experienced >10% weight loss or enrolled in weight loss program within six months of enrolment.
  • require use of medication(s) known to affect insulin sensitivity or secretion within the last 30 days.
  • Medication(s) known to cause weight gain.
  • weight loss medication(s).

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: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Normal Weight
BMI ≥ 18.5 < 25.0 km/m2 Sprint Interval Training
Behavioral: Sprint Interval Training
The 4-week sprint interval intervention will consist of a work-rest ratio of four 30-s intervals of exercise at maximal capacity and 4-min of passive recovery at 50% of maximal capacity between intervals. There will be three sessions per week.
EXPERIMENTAL: Individuals living with Obesity
BMI ≥ 30.0 km/m2 Sprint Interval Training
Behavioral: Sprint Interval Training
The 4-week sprint interval intervention will consist of a work-rest ratio of four 30-s intervals of exercise at maximal capacity and 4-min of passive recovery at 50% of maximal capacity between intervals. There will be three sessions per week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Metabolic Flexibility
Time Frame: Baseline and post-intervention (4 weeks)
Chronic and acute metabolic flexibility will be quantified from the respiratory quotient (RQ) at rest and from the respiratory exchange ratio (RER) during a 4-6 minutes steady rate exercise bout.
Baseline and post-intervention (4 weeks)
Change in Insulin Sensitivity
Time Frame: Baseline and post-intervention (4 weeks)
Insulin sensitivity will be measure with the Matsuda Index
Baseline and post-intervention (4 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Irisin
Time Frame: Baseline and post-intervention (4 weeks)
This hormone will be quantified in the plasma during one acute session of exercise.
Baseline and post-intervention (4 weeks)

Collaborators and Investigators

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

Sponsor

University of New Brunswick

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 (ACTUAL)

July 3, 2018

Primary Completion (ACTUAL)

February 28, 2020

Study Completion (ACTUAL)

February 28, 2020

Study Registration Dates

First Submitted

May 3, 2018

First Submitted That Met QC Criteria

May 15, 2018

First Posted (ACTUAL)

May 17, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 25, 2020

Last Update Submitted That Met QC Criteria

March 24, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UNewBrunswick

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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