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

Primary Purpose

Obesity, Obesity; Endocrine, Insulin Sensitivity

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Sprint Interval Training
Sponsored by
University of New Brunswick
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Metabolic flexibility, Insulin sensitivity, Sprint interval training, Obesity, Exercise intensity

Eligibility Criteria

19 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • University of New Brunswick - Kinesiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Normal Weight

Individuals living with Obesity

Arm Description

BMI ≥ 18.5 < 25.0 km/m2 Sprint Interval Training

BMI ≥ 30.0 km/m2 Sprint Interval Training

Outcomes

Primary Outcome Measures

Change in Metabolic Flexibility
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.
Change in Insulin Sensitivity
Insulin sensitivity will be measure with the Matsuda Index

Secondary Outcome Measures

Change in Irisin
This hormone will be quantified in the plasma during one acute session of exercise.

Full Information

First Posted
May 3, 2018
Last Updated
March 24, 2020
Sponsor
University of New Brunswick
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1. Study Identification

Unique Protocol Identification Number
NCT03527446
Brief Title
Acute and Chronic Metabolic Flexibility in Individuals Living With Obesity: The i-FLEX Study
Acronym
i-FLEX
Official Title
Sprint Interval Training: Insulin Sensitivity and Acute-Chronic Metabolic Flexibility in Individuals Living With Obesity: The i-FLEX Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
July 3, 2018 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
February 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of New Brunswick

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Obesity; Endocrine, Insulin Sensitivity, Exercise
Keywords
Metabolic flexibility, Insulin sensitivity, Sprint interval training, Obesity, Exercise intensity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal Weight
Arm Type
Experimental
Arm Description
BMI ≥ 18.5 < 25.0 km/m2 Sprint Interval Training
Arm Title
Individuals living with Obesity
Arm Type
Experimental
Arm Description
BMI ≥ 30.0 km/m2 Sprint Interval Training
Intervention Type
Behavioral
Intervention Name(s)
Sprint Interval Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Metabolic Flexibility
Description
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.
Time Frame
Baseline and post-intervention (4 weeks)
Title
Change in Insulin Sensitivity
Description
Insulin sensitivity will be measure with the Matsuda Index
Time Frame
Baseline and post-intervention (4 weeks)
Secondary Outcome Measure Information:
Title
Change in Irisin
Description
This hormone will be quantified in the plasma during one acute session of exercise.
Time Frame
Baseline and post-intervention (4 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Senechal, PhD
Organizational Affiliation
University of New Brunswick
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of New Brunswick - Kinesiology
City
Fredericton
State/Province
New Brunswick
ZIP/Postal Code
E3B 5A3
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
25480291
Citation
Muoio DM. Metabolic inflexibility: when mitochondrial indecision leads to metabolic gridlock. Cell. 2014 Dec 4;159(6):1253-62. doi: 10.1016/j.cell.2014.11.034.
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Acute and Chronic Metabolic Flexibility in Individuals Living With Obesity: The i-FLEX Study

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