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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02177604




Registration number
NCT02177604
Ethics application status
Date submitted
19/06/2014
Date registered
27/06/2014
Date last updated
25/05/2018

Titles & IDs
Public title
Can Brief High-intensity Interval Training Mitigate the Adverse Consequences of High-fat Overfeeding?
Scientific title
Can Brief High-intensity Interval Training Mitigate the Adverse Consequences of High-fat Overfeeding?
Secondary ID [1] 0 0
140319
Universal Trial Number (UTN)
Trial acronym
GAINHIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insulin Resistance 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Wingate HIT
Other interventions - Modified HIT
Other interventions - High-fat overfeeding

Experimental: Wingate HIT - 7 days of high-fat overfeeding (50% excess calories) in conjunction 3 supervised sessions of Wingate High-intensity Interval Training.

Experimental: Modified HIT - 7 days of high-fat overfeeding (50% excess calories) in conjunction with 3 supervised sessions of Modified High-Intensity Interval Training

Active comparator: No Exercise Control - 7 days of high-fat overfeeding (50% excess calories) with no supervised exercise


Other interventions: Wingate HIT
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)

Other interventions: Modified HIT
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)

Other interventions: High-fat overfeeding
7 days of high-fat overfeeding (50% excess calories)
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in glucose metabolism
Timepoint [1] 0 0
1 week
Secondary outcome [1] 0 0
Change in plasma levels of cytokines
Timepoint [1] 0 0
1 week

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
45 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key 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 design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2016
Sample size
Target
Accrual to date
Final
7
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
South Australian Health & Medical Research Institute - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
University of Adelaide
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Royal Adelaide Hospital
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of South Australia
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief 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. 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.
Trial website
https://clinicaltrials.gov/study/NCT02177604
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Leonie Heilbronn, PhD
Address 0 0
University of Adelaide
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02177604