Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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