Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000953033
Ethics application status
Approved
Date submitted
4/11/2010
Date registered
8/11/2010
Date last updated
26/02/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
ALPhA Study: Active Living and Physical Activity as modifiers of postprandial lipaemia and other risk factors of cardiovascular disease.
Scientific title
The effect of continuous and intermittent physical activity on postprandial lipaemia in sedentary men and women
Secondary ID [1] 253020 0
None
Universal Trial Number (UTN)
Trial acronym
ALPhA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postprandial Lipaemia 256989 0
inflammation 256990 0
Postprandial Glycaemia 258602 0
Condition category
Condition code
Diet and Nutrition 257143 257143 0 0
Other diet and nutrition disorders
Cardiovascular 258746 258746 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a randomized cross over study, in which, participants will complete the following three, 9 h trials, each separated by at least 7 days: 1) Physical Activity (PA) trial: participants will walk on the treadmill at 60 % of maximal oxygen consumption (VO2max) for 30 min prior to consuming the first meal replacement beverage (MRB) then remained seated for the remainder of the trial; 2) Active Living (AL) trial: participants will walk on the treadmill at the same speed and incline as PA, for 1 min and 40 s every 30 min throughout the trial; and 3) Sedentary (SE) trial: participants will remain seated for the duration. In each trial participants will be fed three MRBs, each providing 0.46 g fat, 0.54 g protein and 1.12 g carbohydrate per kg at 60, 240 and 420 min.
Intervention code [1] 256163 0
Prevention
Intervention code [2] 257556 0
Lifestyle
Comparator / control treatment
No physical activity -The sedentary trial is the control condition. Participants will remain seated for the duration of the 9 hr trial, and be fed three meal replacement beverages each providing 0.46 g fat, 0.54 g protein and 1.12 g carbohydrate per kg at 60, 240 and 420 min.
Control group
Active

Outcomes
Primary outcome [1] 258036 0
Postprandial triglyceride response will be assessed by collecting blood samples at the time points listed below. Concentrations of triglycerides will be measured in each of these samples using enzymatic colorimetric methods
Timepoint [1] 258036 0
Baseline, 30, 45, 60, 120, 180, 210, 225, 240, 300, 360, 420, 450, 465, 480, 540 min after consumption of the first meal
Secondary outcome [1] 263609 0
Postprandial glucose response will be assessed by collecting blood samples at the time points listed below. Concentrations of blood glucose will be measured in each of these samples using enzymatic colorimetric methods.
Timepoint [1] 263609 0
Baseline, 30, 45, 60, 120, 180, 210, 225, 240, 300, 360, 420, 450, 465, 480, 540 min after consumption of the first meal
Secondary outcome [2] 263610 0
Postprandial insulin response will be assessed by collecting blood samples at the time points listed below. Concentrations of blood insulin will be measured in each of these samples using an electrochemiluminescent immunoassay.
Timepoint [2] 263610 0
Baseline, 30, 45, 60, 120, 180, 210, 225, 240, 300, 360, 420, 450, 465, 480, 540 min after consumption of the first meal
Secondary outcome [3] 263611 0
Blood pressure will measured using a sphygmomanometer
Timepoint [3] 263611 0
Baseline, 60, 120, 180, 240, 300, 360, 420, 480, 540 min after consumption of the first meal
Secondary outcome [4] 263612 0
Substrate utilization will be measured by indirect calorimetry
Timepoint [4] 263612 0
Baseline, 60, 120, 180, 240, 300, 360, 420, 480, 540 min after consumption of the first meal

Eligibility
Key inclusion criteria
Healthy men and women who do not regularly undertake more than 3 hours of physical activity a week.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Previously diagnosed cardiovascular disease, diabetes, metabolic disease, high cholesterol or high blood pressure
Resting blood pressure greater than 140/90
History of venous thrombosis or any abnormality of blood clotting
Smoking
Medication known to influence lipid or carbohydrate metabolism

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 will initially attend a screening visit at which blood pressure and fasting lipid will be measured. If blood pressure and lipids are within the acceptable range participants will complete an aerobic capacity test (VO2max). Participants will then complete the three trial conditions in a predetermined randomized order. The randomization code will be sealed in opaque envelopes. An envelope will be opened prior to each participant's first session, and the code contained within will dictate the order the interventions will be completed by that participant
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
STATA software will be used to generate the randomization sequence for the order the interventions will be performed for each participant.
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
7/04/2010
Actual
7/04/2010
Date of last participant enrolment
Anticipated
4/10/2010
Actual
4/10/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
65
Accrual to date
Final
Recruitment outside Australia
Country [1] 2550 0
New Zealand
State/province [1] 2550 0

Funding & Sponsors
Funding source category [1] 256667 0
Self funded/Unfunded
Name [1] 256667 0
Country [1] 256667 0
Primary sponsor type
Individual
Name
Tracy Perry
Address
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin
New Zealand
9054
Country
New Zealand
Secondary sponsor category [1] 255955 0
Individual
Name [1] 255955 0
Nancy Rehrer
Address [1] 255955 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin
New Zealand
9054
Country [1] 255955 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258694 0
University of Otago Human Ethics Committee
Ethics committee address [1] 258694 0
Ethics committee country [1] 258694 0
New Zealand
Date submitted for ethics approval [1] 258694 0
Approval date [1] 258694 0
22/12/2009
Ethics approval number [1] 258694 0
1/09/0239

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30955 0
Dr Tracy Perry
Address 30955 0
Department of Human Nutrition University of Otago PO Box 56 Dunedin New Zealand 9054
Country 30955 0
New Zealand
Phone 30955 0
+64 3 479 7508
Fax 30955 0
Email 30955 0
[email protected]
Contact person for public queries
Name 14202 0
Meredith Peddie
Address 14202 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin
New Zealand
9054
Country 14202 0
New Zealand
Phone 14202 0
+64 3 479 5673
Fax 14202 0
Email 14202 0
[email protected]
Contact person for scientific queries
Name 5130 0
Tracy Perry
Address 5130 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin
New Zealand
9054
Country 5130 0
New Zealand
Phone 5130 0
+64 3 479 7508
Fax 5130 0
Email 5130 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
EmbasePostprandial Metabolic Effects of Accelerometer Measured Spontaneous Low-Level Activity.2015https://dx.doi.org/10.1123/jpah.2014-0298
N.B. These documents automatically identified may not have been verified by the study sponsor.