Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000179831
Ethics application status
Not yet submitted
Date submitted
6/02/2012
Date registered
9/02/2012
Date last updated
9/02/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Exercise and postprandial lipemia - The effect of exercise and bioactive nutrients on vascular and metabolic response to postprandial lipemia
Scientific title
The effect of exercise and bioactive nutrients on vascular and metabolic response to postprandial lipemia in healthy young males
Secondary ID [1] 279888 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vascular problems related to a high fat meal 285788 0
Condition category
Condition code
Cardiovascular 285964 285964 0 0
Other cardiovascular diseases
Diet and Nutrition 285996 285996 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will consist of three sessions; each session will be separated by a one week wash-out period. In Session 1, subjects will consume a high fat meal (HFM). The fat-rich meal will be in milkshake form and will consist of 270 ml of whipping cream and 65 g of specialty ice cream. The meal will provide 4.1 MJ (980 kcal; 0.05 MJ/kg body weight), 100 g fat (1.1 g/kg); 66.5 g saturated, 29.5 monounsaturated, 4.0 g polyunsaturated, 17 g carbohydrate (0.2 g/kg), and 3 g protein (0.03 g/kg). This meal has been successfully used in previous studies to induce postprandial lipemia. All measures will be assessed at pre and post consumption of a HFM. In Session 2, a combination of a HFM and green tea capsules (GTC) will be consumed by subjects; all measures then will be assessed at pre and post consumption of a HFM and GTC combined. The green tea extract will be in capsule form (3 capsules), which will contain 375 mg of epigallo catechin gallate (EGCG). In Session 3, subjects will consume a HFM and GTC, then 2 hours post consumption of a HFM and GTC subjects will undergo a single bout of exercise. All measures will be assessed at pre and post consumption of a HFM and GTC capsules and post acute exercise. The acute exercise protocol will consist of 30 min of steady state exercise on a stationary Monark bike at 60% of subject’s VO2peak. During exercise, subjects will be supervised and their heart rate will be monitored every 2 min by the tester/researcher.
Intervention code [1] 284208 0
Treatment: Other
Intervention code [2] 284232 0
Prevention
Intervention code [3] 284233 0
Lifestyle
Comparator / control treatment
All subjects will receive the same treatment. They will consume a high fat meal (HFM) only, a HFM and green tea capsules (GTC)combined, and a HFM and GTC combined followed by acute exercise.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286458 0
Vascular function and blood markers following a high fat meal (HFM) assessed at pre and post consumption of a HFM. Vascular function will be assessed using Hokanson Plethysmography and lipid profiles will be assessed using Cholestech casette.
Timepoint [1] 286458 0
In Session 1
Primary outcome [2] 286459 0
Vascular function and blood markers following a high fat meal (HFM) combined with green tea capsules (GTC)assessed at pre and post consumption of a HFM and GTC combined. Vascular function will be assessed using Hokanson Plethysmography and lipid profiles will be assessed using Cholestech casette.
Timepoint [2] 286459 0
In Session 2
Primary outcome [3] 286460 0
Vascular function and blood markers following a high fat meal (HFM) combined with green tea capsules (GTC)assessed at pre and post consumption of a HFM and GTC combined as well as post acute exercise. Vascular function will be assessed using Hokanson Plethysmography and lipid profiles will be assessed using Cholestech casette.
Timepoint [3] 286460 0
In Session 3.
Secondary outcome [1] 295923 0
Nil
Timepoint [1] 295923 0
Nil

Eligibility
Key inclusion criteria
Young healthy individuals with a normal body mass index (BMI) of between 18-25kg.m2. Free of medications and diseases
Minimum age
18 Years
Maximum age
30 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
BMI>25kg.m2; smoker, use of medications; hypertension; diabetes

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised 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)
All subjects will receive the same treatment.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284657 0
Self funded/Unfunded
Name [1] 284657 0
Country [1] 284657 0
Primary sponsor type
University
Name
University of New South Wales
Address
High Street
Randwick, NSW 2052
Country
Australia
Secondary sponsor category [1] 283563 0
None
Name [1] 283563 0
Address [1] 283563 0
Country [1] 283563 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286650 0
HREC University of New Soutch Wales
Ethics committee address [1] 286650 0
Ethics committee country [1] 286650 0
Australia
Date submitted for ethics approval [1] 286650 0
28/11/2011
Approval date [1] 286650 0
Ethics approval number [1] 286650 0

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

Contacts
Principal investigator
Name 33740 0
Address 33740 0
Country 33740 0
Phone 33740 0
Fax 33740 0
Email 33740 0
Contact person for public queries
Name 16987 0
Yati Bouthcer
Address 16987 0
School of Medical Sciences
Faculty of Medicine
University of New South Wales
High Street, Randwick, NSW 2052
Country 16987 0
Australia
Phone 16987 0
+61-2-9385 2419
Fax 16987 0
Email 16987 0
[email protected]
Contact person for scientific queries
Name 7915 0
Yati Bouthcer
Address 7915 0
School of Medical Sciences
Faculty of Medicine
University of New South Wales
High Street, Randwick, NSW 2052
Country 7915 0
Australia
Phone 7915 0
+61-2-9385 2419
Fax 7915 0
Email 7915 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.