Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03527446
Recruitment Status : Completed
First Posted : May 17, 2018
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
Martin Senechal, University of New Brunswick

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Obesity Obesity; Endocrine Insulin Sensitivity Exercise Behavioral: Sprint Interval Training Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Individuals living with obesity (BMI ≥ 30 km/m2; n=15) as well as normal weight (BMI ≥ 18.5 < 25.0 km/m2; n=15) adults (aged between 19 to 60 years) will be recruited to participate in the study. All participants will be asked to come in for a total of two visits and participate in a 4-week intervention.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Sprint Interval Training: Insulin Sensitivity and Acute-Chronic Metabolic Flexibility in Individuals Living With Obesity: The i-FLEX Study
Actual Study Start Date : July 3, 2018
Actual Primary Completion Date : February 28, 2020
Actual Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.

  2. Change in Insulin Sensitivity [ Time Frame: Baseline and post-intervention (4 weeks) ]
    Insulin sensitivity will be measure with the Matsuda Index


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03527446


Locations
Layout table for location information
Canada, New Brunswick
University of New Brunswick - Kinesiology
Fredericton, New Brunswick, Canada, E3B 5A3
Sponsors and Collaborators
University of New Brunswick
Investigators
Layout table for investigator information
Principal Investigator: Martin Senechal, PhD University of New Brunswick
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Martin Senechal, Assistant Professor, University of New Brunswick
ClinicalTrials.gov Identifier: NCT03527446    
Other Study ID Numbers: UNewBrunswick
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Martin Senechal, University of New Brunswick:
Metabolic flexibility
Insulin sensitivity
Sprint interval training
Obesity
Exercise intensity
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity
Insulin Resistance
Hypersensitivity
Overnutrition
Nutrition Disorders
Overweight
 Body Weight
Immune System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases