NCT03527446

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 17, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

July 3, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2020

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

1.7 years

First QC Date

May 3, 2018

Last Update Submit

March 24, 2020

Conditions

Keywords

Metabolic flexibilityInsulin sensitivitySprint interval trainingObesityExercise intensity

Outcome Measures

Primary Outcomes (2)

  • 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.

    Baseline and post-intervention (4 weeks)

  • Change in Insulin Sensitivity

    Insulin sensitivity will be measure with the Matsuda Index

    Baseline and post-intervention (4 weeks)

Secondary Outcomes (1)

  • Change in Irisin

    Baseline and post-intervention (4 weeks)

Study Arms (2)

Normal Weight

EXPERIMENTAL

BMI ≥ 18.5 \< 25.0 km/m2 Sprint Interval Training

Behavioral: Sprint Interval Training

Individuals living with Obesity

EXPERIMENTAL

BMI ≥ 30.0 km/m2 Sprint Interval Training

Behavioral: Sprint Interval Training

Interventions

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.

Individuals living with ObesityNormal Weight

Eligibility Criteria

Age19 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of New Brunswick - Kinesiology

Fredericton, New Brunswick, E3B 5A3, Canada

Location

Related Publications (1)

  • 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.

    PMID: 25480291BACKGROUND

MeSH Terms

Conditions

ObesityInsulin ResistanceMotor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesBehavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Martin Senechal, PhD

    University of New Brunswick

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 3, 2018

First Posted

May 17, 2018

Study Start

July 3, 2018

Primary Completion

February 28, 2020

Study Completion

February 28, 2020

Last Updated

March 25, 2020

Record last verified: 2020-03

Locations