Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000188831
Ethics application status
Not yet submitted
Date submitted
10/02/2012
Date registered
14/02/2012
Date last updated
14/02/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of green tea and high intensity intermittent exercise on blood fat levels after consuming a high fat meal
Scientific title
Effect of green tea and high intensity intermittent exercise on postprandial lipemia after consuming a high fat meal in young males
Secondary ID [1] 279915 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postprandial lipemia 285824 0
Diabetes 285825 0
Condition category
Condition code
Metabolic and Endocrine 286004 286004 0 0
Metabolic disorders
Metabolic and Endocrine 286005 286005 0 0
Diabetes
Cardiovascular 286016 286016 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each subject will be involved with four arms of the trial which will consist of: a placebo, a green tea capsule, an exercise bout, and a green tea capsule and exercise bout condition. The green tea and placebo capsules will be ingested with lunch and dinner on the day before the high fat meal and in the morning, 1.5 hour before the high fat meal. The high fat meal will be consumed after overnight fasting early in the morning. exercise will be performed 12 hours before consumption of the high fat meal. The green tea will consist of a standardized green tea (total of 340 mg polyphenols and 136 mg EGCG), maltodextrin, microcrystalline cellulose, sodium croscarmellose, stearic acid, silicon dioxide, magnesium stearate (vegetable origin), hydroxypropylmethyl cellulose coating, and glycerine (vegetable origin). The amount of green tea contained in each capsule will be equivalent to three cups of green tea. Exercise will consist of cycling on a stationary bike for 20 minutes. The high fat 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). Percent fat is about 92%. This meal has been successfully used in previous studies to induce postprandial lipemia. Twelve hours before the high fat meal subjects will perform 20 minutes of high intensity intermittent exercise when in the exerclse alone or exercise/green tea condition. Exercise will consist of cycling flat out for 8 s then resting (turn the pedals over slowly) for 12 s continuously for a 20-min period. Thus, in a 20-min period subjects will cycle vigorously for 8 min and cycle slowly for 12 min (60 sprints). Load will be determined from subject’s maximal oxygen uptake values. Heart rates are typically between 150 and 160 bpm during this protocol. Period between conditions will be one week. One order out of a possible six different order of the above conditions will be randomly assigned to subjects'
Intervention code [1] 284242 0
Lifestyle
Intervention code [2] 284243 0
Prevention
Comparator / control treatment
Subjects will ingest a placebo capsule that will contain 500 mg of cellulose.
Control group
Placebo

Outcomes
Primary outcome [1] 286494 0
We hypothesize that high intensity intermittent exercise and green tea will result in a:

* significant decrease in blood levels of triglyceride after consumption of the high fat meal
Timepoint [1] 286494 0
After a high fat meal consumed along with green tea capsules and a bout of prior exercise blood fats will peak about 3-4 hours later but it is expected that their levels will be significantly lower after green tea and exercise. Two blood samples will be collected at baseline, and three during the resting phase (one per hour). Thus, 5 samples per subject will be analyzed.
Primary outcome [2] 286506 0
We hypothesize that high intensity intermittent exercise and green tea will result in a:

* significant decrease in fat oxidation levels after consumption of the high fat meal
Timepoint [2] 286506 0
Fat oxidation will be assessed through a metabolic cart and canopy. Gases will collected throughout the 3-hour period after the high fat meal.
Secondary outcome [1] 296041 0
Secondary outcomes will be the assessment of glycerol and growth hormone from the blood samples which are expected to be larger in the green tea and exercise conditions.
Timepoint [1] 296041 0
Two blood samples will be collected at baseline, and three during the resting phase (one per hour).

Eligibility
Key inclusion criteria
Male, aged between 18 and 30 years. No history of exercise or consumption of green tea. exercise history will be assessed by a lifestyle questionnaire and use of the seven day physical activity recall questionnaire. Exclusion will be based on an exercise regimen that involves moderately hard exercise for more than two times per week.
Minimum age
18 Years
Maximum age
30 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion
- Smokers
- On any regular medication
- Regular green tea consumption
- Suffering from diabetes or any cardiovascular diseases
- Any other clinical conditions which may prevent them from participating in this clinical trial

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)
All subjects will complete four conditions:
1. Placebo
2. Exercise
3. Green tea ingestion
4. Exercise and green tea ingestion

Allocation will be by sealed opaque envelopes. Allocation will be concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Order of conditions will be balanced across subjects. One order out of a possible six different order of the above conditions will be randomly assigned to subjects. Order of conditions to each subject will be decided by drawing each subject order from 24 possible permutations from a hat.
Masking / blinding
Blinded (masking 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
1/04/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284692 0
Self funded/Unfunded
Name [1] 284692 0
Country [1] 284692 0
Primary sponsor type
University
Name
University New South wales
Address
High Street
Randwick
Sydney 2052
New South Wales
Country
Australia
Secondary sponsor category [1] 283593 0
None
Name [1] 283593 0
Address [1] 283593 0
Country [1] 283593 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286689 0
Ethics committee address [1] 286689 0
Ethics committee country [1] 286689 0
Date submitted for ethics approval [1] 286689 0
10/02/2012
Approval date [1] 286689 0
Ethics approval number [1] 286689 0

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

Contacts
Principal investigator
Name 33760 0
Address 33760 0
Country 33760 0
Phone 33760 0
Fax 33760 0
Email 33760 0
Contact person for public queries
Name 17007 0
Stephen H Boutcher
Address 17007 0
4 Arthur St
School of Medical Sciences
Faculty of Medicine
University New South Wales
Randwick NSW 2031
Country 17007 0
Australia
Phone 17007 0
61 (2) 9385 2877
Fax 17007 0
Email 17007 0
[email protected]
Contact person for scientific queries
Name 7935 0
Stephen H Boutcher
Address 7935 0
4 Arthur St
School of Medical Sciences
Faculty of Medicine
University New South Wales
Randwick NSW 2031
Country 7935 0
Australia
Phone 7935 0
61 (2) 9385 2877
Fax 7935 0
Email 7935 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.