Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001230842
Ethics application status
Approved
Date submitted
31/10/2012
Date registered
21/11/2012
Date last updated
21/11/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The Role of Exercise Intensity in the Understanding of Metabolic Flexibility in Healthy Lean, Overweight and Obese Individuals
Scientific title
The Role of Exercise Intensity in the Understanding of Metabolic Flexibility in Healthy Lean, Overweight and Obese Individuals
Secondary ID [1] 281478 0
None
Secondary ID [2] 281560 0
Nil
Universal Trial Number (UTN)
U1111-1136-5794
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight and Obesity 287738 0
Metabolic Flexibility 287842 0
Condition category
Condition code
Human Genetics and Inherited Disorders 288079 288079 0 0
Other human genetics and inherited disorders
Physical Medicine / Rehabilitation 288080 288080 0 0
Other physical medicine / rehabilitation
Diet and Nutrition 288186 288186 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be asked to perform exercise tests during two testing sessions. One exercise test will involve a single bout of cycle ergometer exercise at 80% (HI) VO2max for 38 minutes which expends ~400 kcal). This is a crossover study with the order of the exercise tests being randomised. The second test will occur a minimum of 1 week following the commencment of first exercise test (maximum of up to 4 weeks). This washout period will be based on participant availability, work place availability, and human physiology (ie: females will be asked to perform exercise trials only within the proliferative phase of their menstral cycle).
Intervention code [1] 285982 0
Prevention
Intervention code [2] 285983 0
Treatment: Other
Intervention code [3] 285984 0
Behaviour
Comparator / control treatment
Lean, overweight and obese participants will be there own controls (crossover study). Participants will be asked to perform a single bout of cycle ergometer exercise at 40% (LO) VO2max for 70 minutes which expends ~400 kcal
Control group
Active

Outcomes
Primary outcome [1] 288286 0
Identify key differences in cellular pathways involved in energy metabolism at rest and following an acute bouts of exercise between healthy lean, overweight and obese individuals by using metabolomic technologies to analysis serum and muscle samples, and genomic technologies to examine genetic differences.
Timepoint [1] 288286 0
At baseline/prior to exercise (DNA, serum & muscle), every 10 minutes during exercise (serum), immediately following exercise (serum and muscle), 15 minutes following exercise (serum), and 3 hours following exercise (serum and muscle).
Secondary outcome [1] 299763 0
Nil
Timepoint [1] 299763 0
Nil

Eligibility
Key inclusion criteria
Participants will be considered relatively healthy lean, overweight and obese individuals. Participants will be included if they have adequate glucose handling (no diagnosed diabetes, fasting blood glucose must be less than 7.0 mmol/L), not performing any regular fitness training (i.e. greater than 30 minutes, 3 times per week) for the past 6 months, not taking contraindicated prescription medication (i.e. thyroid, hyperlipidmeic, hypoglycemic, or antihypertensive), non-pregnant, not peri- or post-menopausal, must have physician approval (overweight and obese participants only), and not current involvement in other research studies.
Minimum age
20 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded from participating within the project for the following reasons: diagnosed diabetes (fasting blood glucose greater than 7.0 mmol/L), performing any regular fitness training (i.e. greater than 30 minutes, 3 times per week) for the past 6 months, taking contraindicated prescription medication (i.e. thyroid, hyperlipidmeic, hypoglycemic, or antihypertensive), pregnant, peri- and post-menopausal women, no physician approval (overweight and obese participants only), and current involvement in other research studies.

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation of the order in which each participant will perform exercise tests will be made by coin-tossing.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 286248 0
University
Name [1] 286248 0
Victoria University
Country [1] 286248 0
Australia
Primary sponsor type
University
Name
Victoria University
Address
Address: McKechnie Street, St Albans VIC 3021
Country
Australia
Secondary sponsor category [1] 285051 0
None
Name [1] 285051 0
Address [1] 285051 0
Country [1] 285051 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288325 0
Victoria University Human Research Ethics Committte
Ethics committee address [1] 288325 0
Address: Ballarat Rd, Footscray VIC 3011
Ethics committee country [1] 288325 0
Australia
Date submitted for ethics approval [1] 288325 0
25/10/2012
Approval date [1] 288325 0
Ethics approval number [1] 288325 0
1/12/0197

Summary
Brief summary
The aim of this project is to identify key differences in cellular pathways involved in energy metabolism at rest and following an acute bout of exercise between healthy overweight and obese and lean individuals. Forty age-matched and fitness-matched (20 lean, 20 overweight and/or obese) healthy males and females between the ages of 20 and 50 years will be recruited. Participants will perform a buccal swab and donate a venous blood sample to obtain a genetic and metabolic signature profile at rest. Participants will perform a low (40% VO2peak-LO) and high-intensity (80% VO2peak-HI) exercise bout for approximately 70 and 38 minutes, respectively, separated by 2 weeks. A DEXA scan will be performed prior to the first exercise test. Venous blood will be sampled prior to, immediately after, 15 minutes, and 3 hours following completion of the exercise. Muscle biopsies will be sampled prior to, 15 minutes and 3 hours following completion of the exercise. Urine samples will be collected prior to, 90 minutes and 3 hours following the completion of the exercise. This proposed project will allow parallel measurement of metabolism in response to exercise intensity and to be mapped against variations in genetic disposition. This will help identify and contextualize biomarkers of metabolic flexibility or inflexibility in healthy overweight and obese individuals. These biomarkers can then be used as targets for exercise, nutrition and pharmacological interventions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34901 0
Address 34901 0
Country 34901 0
Phone 34901 0
Fax 34901 0
Email 34901 0
Contact person for public queries
Name 18148 0
Miss Jessica Danaher
Address 18148 0
Address: Victoria University (St Albans Campus)McKechnie Street, St Albans VIC 3021
Country 18148 0
Australia
Phone 18148 0
+61 421 479 868
Fax 18148 0
Email 18148 0
[email protected]
Contact person for scientific queries
Name 9076 0
Miss Jessica Danaher
Address 9076 0
Address: Victoria University (St Albans Campus)McKechnie Street, St Albans VIC 3021
Country 9076 0
Australia
Phone 9076 0
+61 421 479 868
Fax 9076 0
Email 9076 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.