Obesityi-FLEXNCT03527446
Acute and Chronic Metabolic Flexibility in Individuals Living With Obesity: The i-FLEX Study
A study testing Sprint Interval Training in people with Obesity and Obesity; Endocrine, run by University of New Brunswick at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Obesity; Endocrine, Insulin Sensitivity
- What is being tested?
- Sprint Interval Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteCanada
- Study dates
- 3 Jul 2018to 28 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Show all 9Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of New Brunswick - Kinesiology
Fredericton, New Brunswick, E3B 5A3
About this study
Official title: 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.
- Conditions
- Obesity, Obesity; Endocrine, Insulin Sensitivity, Exercise
- Being tested
- Sprint Interval Training
- Keywords
- Metabolic flexibility, Insulin sensitivity, Sprint interval training, Obesity, Exercise intensity
- Medical subject headings
- Obesity, Insulin Resistance, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sprint Interval TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Normal Weight | Experimental | BMI ≥ 18.5 < 25.0 km/m2 Sprint Interval Training Receives: Behavioral: Sprint Interval Training |
| Individuals living with Obesity | Experimental | BMI ≥ 30.0 km/m2 Sprint Interval Training Receives: Behavioral: Sprint Interval Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and post-intervention (4 weeks)
Change in Insulin Sensitivity
Insulin sensitivity will be measure with the Matsuda Index
Measured: Baseline and post-intervention (4 weeks)
Secondary outcomes (1)
Change in Irisin
This hormone will be quantified in the plasma during one acute session of exercise.
Measured: Baseline and post-intervention (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start3 Jul 2018
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Brunswick
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Senechal, University of New Brunswick
- Investigators
- Martin Senechal, PhD, Principal investigator, University of New Brunswick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03527446
- Sponsor's protocol ID
- UNewBrunswick
- Acronym
- i-FLEX
- Status last verified
- Mar 2020
- First submitted
- 3 May 2018
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25480291
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sprint Interval Training: Insulin Sensitivity and Acute-Chronic Metabolic Flexibility in Individuals Living With Obesity: The i-FLEX Study
- ClinicalTrials.gov ID
- NCT03527446
- Acronym / sponsor ID
- i-FLEX / UNewBrunswick
- Conditions
- Obesity, Obesity; Endocrine, Insulin Sensitivity, Exercise
- Keywords
- Metabolic flexibility, Insulin sensitivity, Sprint interval training, Obesity, Exercise intensity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of New BrunswickUniversity, hospital or other
- Study start
- 3 Jul 2018 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 17 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Normal Weight | Experimental | Behavioral: Sprint Interval TrainingBMI ≥ 18.5 < 25.0 km/m2 Sprint Interval Training |
| Individuals living with Obesity | Experimental | Behavioral: Sprint Interval TrainingBMI ≥ 30.0 km/m2 Sprint Interval Training |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sprint Interval TrainingThe 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. | Behavioural | Individuals living with Obesity, Normal Weight |
Primary outcome
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.
Change in Insulin Sensitivity
Time frame: Baseline and post-intervention (4 weeks)
Insulin sensitivity will be measure with the Matsuda Index
1 secondary outcome
Change in Irisin
Time frame: Baseline and post-intervention (4 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Background: PubMed 25480291Muoio 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Senechal, PhD principal investigator
University of New Brunswick
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sprint Interval Training in people with Obesity and Obesity; Endocrine, run by University of New Brunswick at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Metabolic Flexibility (time frame: Baseline and post-intervention (4 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03527446, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.