Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000897864
Ethics application status
Approved
Date submitted
21/08/2012
Date registered
23/08/2012
Date last updated
27/08/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Exercise and coronary heart disease (CHD) risk markers in South Asian and European men
Scientific title
The effect of exercise on postprandial plasma triacylglycerol and other coronary heart disease risk markers in South Asian and European men
Secondary ID [1] 281070 0
Nil
Secondary ID [2] 281078 0
Nil
Universal Trial Number (UTN)
U1111-1133-5935
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postprandial lipaemia 287221 0
Blood lipids 287228 0
Markers for inflammation 287229 0
Condition category
Condition code
Cardiovascular 287545 287545 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study consisted of two, 2-day trials (exercise and control). Each trial involved two, nine hour days in a laboratory (8:00 am to 5:00 pm). Participants performed a one-hour treadmill run at approximately 70% of maximum oxygen uptake on day 1 of the exercise trial. All exercise sessions were supervised on a one to one basis by an exercise physiologist. Participants rested on day 1 of the control trial. During day 2 of both trials participants ate standardised meals for breakfast (8:00 am) and lunch (12:00 pm). These meals consisted of white bread, butter, cheese, mayonnaise, crisps, chocolate milk shake powder and high fat milk. The macronutrient content of these meals was 57% fat, 32% carbohydrate and 11% protein and each meal provided 60 kJ (14.3 kcal) per kg body mass for a 70 kg participant. Fourteen, 9 mL venous blood samples were collected during day 2 of each trial via a cannula. Participants were assigned to the trials in a random order and trials were separated by at least one week.
Intervention code [1] 285527 0
Lifestyle
Intervention code [2] 285528 0
Prevention
Intervention code [3] 285529 0
Behaviour
Comparator / control treatment
The control treatment is rest i.e. no exercise
Control group
Active

Outcomes
Primary outcome [1] 287787 0
Plasma triaclyglycerol concentration
Timepoint [1] 287787 0
0, 0.25, 0.5, 1, 2, 3, 4, 4.25, 4.5, 5, 6, 7, 8 and 9 hours on day 2 in both the exercise and control trials
Primary outcome [2] 287788 0
Plasma glucose concentration
Timepoint [2] 287788 0
0, 0.25, 0.5, 1, 2, 3, 4, 4.25, 4.5, 5, 6, 7, 8 and 9 hours on day 2 in both the exercise and control trials
Primary outcome [3] 287789 0
Plasma insulin concentration
Timepoint [3] 287789 0
0, 0.25, 0.5, 1, 2, 3, 4, 4.25, 4.5, 5, 6, 7, 8 and 9 hours on day 2 in both the exercise and control trials
Secondary outcome [1] 298843 0
Plasma interleukin-6 concentration
Timepoint [1] 298843 0
0, 3, 6 and 9 hours on day 2 in both the exercise and control trials
Secondary outcome [2] 298844 0
Plasma soluble intercellular adhesion molecule-1 concentration
Timepoint [2] 298844 0
0, 3, 6 and 9 hours on day 2 in both the exercise and control trials

Eligibility
Key inclusion criteria
South Asian and Eurpoean participants.
Minimum age
18 Years
Maximum age
40 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Smoking;
Known history of cardiovascular disease, metabolic disease or dyslipidaemia;
Not dieting or following extreme dietary habits;
Not on medication affecting digestion or metabolism – medical or illegal

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)
Block randomised trial order
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
Completed
Date of first participant enrolment
Anticipated
8/02/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 4497 0
United Kingdom
State/province [1] 4497 0

Funding & Sponsors
Funding source category [1] 285856 0
University
Name [1] 285856 0
Loughborough University
Country [1] 285856 0
United Kingdom
Primary sponsor type
University
Name
Loughborough University
Address
c/o David Stensel
School of Sport, Exercise and Health Sciences
Loughborough University
Loughborough
Leicestershire
LE11 3TU
Country
United Kingdom
Secondary sponsor category [1] 284676 0
None
Name [1] 284676 0
Address [1] 284676 0
Country [1] 284676 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287877 0
Loughborough University Ethical Advisory Committee
Ethics committee address [1] 287877 0
Research Office
Loughborough University
Loughborough
Leicestershire
LE11 3TU
Ethics committee country [1] 287877 0
United Kingdom
Date submitted for ethics approval [1] 287877 0
Approval date [1] 287877 0
11/01/2010
Ethics approval number [1] 287877 0
R10-P3

Summary
Brief summary
South Asians have a higher than average risk of coronary heart disease. The reasons for this are unclear but physical inactivity and/or poor responsiveness to exercise may play a role. The proposed study compared the prior effect of a single bout of running on CHD risk markers in South Asian and European men.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 34602 0
Address 34602 0
Country 34602 0
Phone 34602 0
Fax 34602 0
Email 34602 0
Contact person for public queries
Name 17849 0
David Stensel
Address 17849 0
School of Sport, Exercise and Health Sciences
Loughborough University
Loughborough
Leicestershire
LE11 3TU
Country 17849 0
United Kingdom
Phone 17849 0
+44 (0)1509 226344
Fax 17849 0
Email 17849 0
[email protected]
Contact person for scientific queries
Name 8777 0
David Stensel
Address 8777 0
School of Sport, Exercise and Health Sciences
Loughborough University
Loughborough
Leicestershire
LE11 3TU
Country 8777 0
United Kingdom
Phone 8777 0
+44 (0)1509 226344
Fax 8777 0
Email 8777 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
SourceTitleYear of PublicationDOI
Dimensions AIExercise and Coronary Heart Disease Risk Markers in South Asian and European Men2013https://doi.org/10.1249/mss.0b013e3182853ecf
N.B. These documents automatically identified may not have been verified by the study sponsor.