Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001115921
Ethics application status
Approved
Date submitted
21/10/2011
Date registered
25/10/2011
Date last updated
25/10/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of walking on responses to high-fat meals in teenage boys
Scientific title
Influence of a 60-minute bout of walking on postprandial triacylglycerol concentrations and endothelial function in adolescent males
Secondary ID [1] 273250 0
Nil
Universal Trial Number (UTN)
U1111-1125-3624
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary heart disease 279011 0
Endothelial dysfunction 279012 0
Hypertriglyceridemia 279013 0
Condition category
Condition code
Cardiovascular 279198 279198 0 0
Normal development and function of the cardiovascular system
Metabolic and Endocrine 279199 279199 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In a randomised cross-over design, participants will either be inactive or complete sixty minutes of moderate intensity exercise (treadmill walking at 60% of peak oxygen uptake) in the late afternoon (4 - 5 pm) prior to the ingestion of a standardised high-fat breakfast and lunch.

The breakfast provides 1.5 g fat (60% Energy), 1.8 g carbohydrate (33%), 0.4 g protein (7%) and 92.9 kJ per kilogram body mass. The lunch provides 1.1 g fat (50%), 1.9 g carbohydrate (37%), 0.6 g protein (13%) and 84.6 kJ per kilogram of body mass. Breakfast is consumed between 08:30 - 09:30 and lunch 3.5 hours later between 12:00 - 13:00.

Each trial will be separated by a period of seven days.
Intervention code [1] 269588 0
Prevention
Intervention code [2] 269602 0
Lifestyle
Comparator / control treatment
Participants will refrain from physical activity the day prior to ingestion of a standardised high-fat breakfast and lunch
Control group
Active

Outcomes
Primary outcome [1] 279833 0
Endothelial function measured as flow-mediated dilation
Timepoint [1] 279833 0
Measurements made pre-breakfast (0 h) and post-breakfast (3 h and 6.5 h)
Primary outcome [2] 279834 0
Plasma triacylglycerol concentration
Timepoint [2] 279834 0
Measurements made pre-breakfast (0 h) and post-breakfast (0.5 h, 1 h, 3 h, 4 h, 4.5 h and 6.5 h)
Secondary outcome [1] 294532 0
Plasma insulin concentration
Timepoint [1] 294532 0
Measurements made pre-breakfast (0 h) and post-breakfast (0.5 h, 1 h, 3 h, 4 h, 4.5 h and 6.5 h)
Secondary outcome [2] 294533 0
Plasma glucose concentration
Timepoint [2] 294533 0
Measurements made pre-breakfast (0 h) and post-breakfast (0.5 h, 1 h, 3 h, 4 h, 4.5 h and 6.5 h)

Eligibility
Key inclusion criteria
1. Aged 12 - 14 years
2. Male
Minimum age
12 Years
Maximum age
14 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Smoking
2. Known metabolic disease
3. On medication that affects lipid or carbohydrate metabolism
4. Individuals with any known bleeding disorder

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)
Participants eligibility was determined prior to a preliminary visit through a health screen. Randomisation was performed on completion of the preliminary visit with the investigator deciding on eligibility not knowing at the time the trial allocation with allocation occuring at a later time point using central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants were randsomised using block randomisation (block size = 2). Randomization table created by a computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Block randomised, counter-balanced, cross-over design with seven days seperating main trials
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/01/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment outside Australia
Country [1] 3919 0
United Kingdom
State/province [1] 3919 0

Funding & Sponsors
Funding source category [1] 270077 0
University
Name [1] 270077 0
Loughborough University
Country [1] 270077 0
United Kingdom
Primary sponsor type
University
Name
Loughborough University
Address
c/o Laura Barrett
School of Sport, Exercise and Health Sciences
Loughborough University
Loughborough
LEICS
LE11 3TU
Country
United Kingdom
Secondary sponsor category [1] 269044 0
None
Name [1] 269044 0
Address [1] 269044 0
Country [1] 269044 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272033 0
Loughborough University's Ethical Advisory Committe
Ethics committee address [1] 272033 0
Research office
Loughborough University
Loughborough
LEICS
LE11 3TU
Ethics committee country [1] 272033 0
United Kingdom
Date submitted for ethics approval [1] 272033 0
01/10/2010
Approval date [1] 272033 0
19/10/2010
Ethics approval number [1] 272033 0
R10-P128

Summary
Brief summary
Background: The ingestion of high-fat meals impairs endothelial function in adults and this impairment is attenuated by exercise. The response of young people to these nutritional and physiological stressors has not been established.

Objectives: To investigate if endothelial function is impaired following the ingestion of a high-fat breakfast and lunch in adolescent boys, and if a bout of moderate-intensity exercise could attenuate any impairment if present.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33293 0
Address 33293 0
Country 33293 0
Phone 33293 0
Fax 33293 0
Email 33293 0
Contact person for public queries
Name 16540 0
Laura Barrett
Address 16540 0
School of Sport, Exercise and Health Sciences
Loughborough University
Loughborough
LEICS
LE11 3TU
Country 16540 0
United Kingdom
Phone 16540 0
+44 01509 226395
Fax 16540 0
Email 16540 0
[email protected]
Contact person for scientific queries
Name 7468 0
Laura Barrett
Address 7468 0
School of Sport, Exercise and Health Sciences
Loughborough University
Loughborough
LEICS
LE11 3TU
Country 7468 0
United Kingdom
Phone 7468 0
+44 01509 226395
Fax 7468 0
Email 7468 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
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