- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02177604
Can Brief High-intensity Interval Training Mitigate the Adverse Consequences of High-fat Overfeeding? (GAINHIT)
May 23, 2018 updated by: A/Prof Leonie Heilbronn, University of Adelaide
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 Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
7
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
South Australia
-
Adelaide, South Australia, Australia, 5000
- South Australian Health & Medical Research Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Sedentary (no more than 2 sessions of structured moderate intensity aerobic exercise or resistance training per week)
- Overweight (BMI 25-29.9 kg/m2)
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Wingate HIT
7 days of high-fat overfeeding (50% excess calories) in conjunction 3 supervised sessions of Wingate High-intensity Interval Training.
|
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)
7 days of high-fat overfeeding (50% excess calories)
|
|
Experimental: Modified HIT
7 days of high-fat overfeeding (50% excess calories) in conjunction with 3 supervised sessions of Modified High-Intensity Interval Training
|
7 days of high-fat overfeeding (50% excess calories)
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)
|
|
Active Comparator: No Exercise Control
7 days of high-fat overfeeding (50% excess calories) with no supervised exercise
|
7 days of high-fat overfeeding (50% excess calories)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in plasma levels of cytokines
Time Frame: 1 week
|
Change in plasma levels of adiponectin, irisin, sex hormone-binding globulin and c-reactive protein
|
1 week
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in mitochondrial metabolism
Time Frame: 1 week
|
Changes in citrate synthase activity, mitochondrial DNA content and protein levels of PGC-1a
|
1 week
|
|
Change in resting energy expenditure
Time Frame: 1 week
|
Changes in resting energy expenditure measured by metabolic cart
|
1 week
|
|
Change in cognitive function
Time Frame: 1 week
|
Changes in cognitive function, assessed by a series of computer tasks involving vigilant attention and speed processing.
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2014
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
June 19, 2014
First Submitted That Met QC Criteria
June 25, 2014
First Posted (Estimate)
June 27, 2014
Study Record Updates
Last Update Posted (Actual)
May 25, 2018
Last Update Submitted That Met QC Criteria
May 23, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 140319
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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