Insulin ResistanceGAINHITNCT02177604
Can Brief High-intensity Interval Training Mitigate the Adverse Consequences of High-fat Overfeeding?
A study testing Wingate HIT, Modified HIT and High-fat overfeeding in people with Insulin Resistance, run by University of Adelaide at 1 site in Australia.
Trial summary
Previous research has shown that indulging in 50% more calories than required for as little as 3 days can significantly impact markers of metabolic health in lean and overweight individuals. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- Wingate HIT, Modified HIT and High-fat overfeeding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteAustralia
- Study dates
- Nov 2014to Dec 2016
- 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 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sedentary (no more than 2 sessions of structured moderate intensity aerobic exercise or resistance training per week)
- Overweight (BMI 25-29.9 kg/m2)
Who cannot join
- Personal history of any major illness (i.e. cardiovascular disease, diabetes, hypertension, cancer, renal/liver impairments, major psychiatric disorders, eating disorders etc.)
- History of chest pain (either at rest or during exercise.)
- Abnormal resting ECG at screening visit
- Chronic use of any prescribed or non-prescribed medications (i.e. anti-hypertensive, statins, metformin, anti-inflammatories, antidepressants etc.)
- Blood pressure or blood lipids outside of reference ranges
- Serum ferritin <30ng/mL
Show all 15Show fewer
- Uncontrolled asthma, current fever, or upper respiratory infection
- Current intake of > 140g alcohol/week
- Current smokers of cigarettes/cigars/marijuana
- Current intake of any illicit substance
- Experience claustrophobia in confined spaces
- Donated blood in the past 3 months
- Migraines
- Unable to comprehend study protocol
- Unable to perform exercise on a cycle ergometer at second screening visit
Trial locations and contacts
1 site in 1 country.
Australia1 site
South Australian Health & Medical Research Institute
Adelaide, South Australia, 5000
About this study
Previous research has shown that indulging in 50% more calories than required for as little as 3 days can significantly impact markers of metabolic health in lean and overweight individuals. Here, the investigators will determine if 3 brief sessions of high-intensity interval training can mitigate the adverse consequences of 7 days high-fat overfeeding in sedentary, overweight males.
- Conditions
- Insulin Resistance
- Being tested
- Wingate HIT, Modified HIT, High-fat overfeeding
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wingate HITOther
3 sessions of Wingate based High-Intensity Interval Training (6-8 x 15 second "all out" sprints on a cycle ergometer interspersed by 2 minutes recovery)
Modified HITOther
3 sessions of Modified High-Intensity Interval Training (8 x 60 second sprints at approximately 90-95% VO2 peak on a cycle ergometer interspersed by 60 seconds recovery)
High-fat overfeedingOther
7 days of high-fat overfeeding (50% excess calories)
| Study group | Role | What they receive |
|---|---|---|
| Wingate HIT | Experimental | 7 days of high-fat overfeeding (50% excess calories) in conjunction 3 supervised sessions of Wingate High-intensity Interval Training. Receives: Other: Wingate HIT; Other: High-fat overfeeding |
| Modified HIT | Experimental | 7 days of high-fat overfeeding (50% excess calories) in conjunction with 3 supervised sessions of Modified High-Intensity Interval Training Receives: Other: Modified HIT; Other: High-fat overfeeding |
| No Exercise Control | Active comparator | 7 days of high-fat overfeeding (50% excess calories) with no supervised exercise Receives: Other: High-fat overfeeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glucose metabolism
Changes in insulin and glucose area under the curve assessed via 75g Oral Glucose Tolerance Test.
Measured: 1 week
Secondary outcomes (1)
Change in plasma levels of cytokines
Change in plasma levels of adiponectin, irisin, sex hormone-binding globulin and c-reactive protein
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Adelaide
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Adelaide Hospital, University of South Australia
- Responsible party
- Principal investigator, A/Prof Leonie Heilbronn, University of Adelaide
- Investigators
- Leonie Heilbronn, PhD, Principal investigator, University of Adelaide
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02177604
- Sponsor's protocol ID
- 140319
- Acronym
- GAINHIT
- Status last verified
- May 2018
- First submitted
- 19 Jun 2014
- Last updated
- 25 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Brief High-intensity Interval Training Mitigate the Adverse Consequences of High-fat Overfeeding?
- ClinicalTrials.gov ID
- NCT02177604
- Acronym / sponsor ID
- GAINHIT / 140319
- Conditions
- Insulin Resistance
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of AdelaideUniversity, hospital or other
- Collaborators
- Royal Adelaide Hospital, University of South Australia
- Study start
- Nov 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 27 Jun 2014 (estimated)
- 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.
Previous research has shown that indulging in 50% more calories than required for as little as 3 days can significantly impact markers of metabolic health in lean and overweight individuals. Here, the investigators will determine if 3 brief sessions of high-intensity interval training can mitigate the adverse consequences of 7 days high-fat overfeeding in sedentary, overweight males.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Wingate HIT | Experimental | Other: Wingate HIT, Other: High-fat overfeeding7 days of high-fat overfeeding (50% excess calories) in conjunction 3 supervised sessions of Wingate High-intensity Interval Training. |
| Modified HIT | Experimental | Other: Modified HIT, Other: High-fat overfeeding7 days of high-fat overfeeding (50% excess calories) in conjunction with 3 supervised sessions of Modified High-Intensity Interval Training |
| No Exercise Control | Active comparator | Other: High-fat overfeeding7 days of high-fat overfeeding (50% excess calories) with no supervised exercise |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Sedentary (no more than 2 sessions of structured moderate intensity aerobic exercise or resistance training per week)
- Overweight (BMI 25-29.9 kg/m2)
Key exclusion criteria (15 listed)
- Personal history of any major illness (i.e. cardiovascular disease, diabetes, hypertension, cancer, renal/liver impairments, major psychiatric disorders, eating disorders etc.)
- History of chest pain (either at rest or during exercise.)
- Abnormal resting ECG at screening visit
- Chronic use of any prescribed or non-prescribed medications (i.e. anti-hypertensive, statins, metformin, anti-inflammatories, antidepressants etc.)
- Blood pressure or blood lipids outside of reference ranges
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 |
|---|---|---|
| Wingate HIT3 sessions of Wingate based High-Intensity Interval Training (6-8 x 15 second "all out" sprints on a cycle ergometer interspersed by 2 minutes recovery) | Other | Wingate HIT |
| Modified HIT3 sessions of Modified High-Intensity Interval Training (8 x 60 second sprints at approximately 90-95% VO2 peak on a cycle ergometer interspersed by 60 seconds recovery) | Other | Modified HIT |
| High-fat overfeeding7 days of high-fat overfeeding (50% excess calories) | Other | Modified HIT, No Exercise Control, Wingate HIT |
Primary outcome
Change in glucose metabolism
Time frame: 1 week
Changes in insulin and glucose area under the curve assessed via 75g Oral Glucose Tolerance Test.
1 secondary outcome
Change in plasma levels of cytokines
Time frame: 1 week
Results and safety
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2018.
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Healthy Volunteer
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.
Leonie Heilbronn, PhD principal investigator
University of Adelaide
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wingate HIT, Modified HIT and High-fat overfeeding in people with Insulin Resistance, run by University of Adelaide at 1 site in Australia.
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 2 inclusion and 15 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: stopped early, as of the sponsor's last update on 25 May 2018. 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 Australia. 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 was stopped early (reason given: Lack of funding). Results are not available in the source record.
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 glucose metabolism (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2018.