Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000965000
Ethics application status
Not yet submitted
Date submitted
28/10/2010
Date registered
9/11/2010
Date last updated
9/11/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of exercise and green tea consumption on fat loss
Scientific title
The effect of high intensity intermittent exercise and green tea consumption on fat loss and insulin resistance of overweight men
Secondary ID [1] 252778 0
There are no secondary IDs
Universal Trial Number (UTN)
Trial acronym
No trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight 258278 0
Insulin resistance 258279 0
Condition category
Condition code
Metabolic and Endocrine 258470 258470 0 0
Diabetes
Metabolic and Endocrine 258759 258759 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will include 12 weeks of high intensity intermittent exercise and ingestion of green tea. Groups will be control, exercise, green tea, and green tea/exercise. The exercise group will perform high intensity intermittent exercise (HIIE) three times per week for 12 weeks. Each session will be 20 minutes duration and will involve sprinting on a stationary bike for 8 seconds and easy pedaling for 12 seconds. This is repeated for the 20 minutes. Each session will be supervised and heart rate will be monitored throughout. The speed of pedaling will be 110 revolutions per minute and the resistance on the bike will be 60% of each subject's VO2max which will be assessed at the start and end of the trial. Typically, the resistance on the bike will be from .75 to 1.5 kg. The green supplementation group will ingest 1500 mg of commercial green tea (GNC Herbal Plus) in capsule form (3 capsules), containing 375 mg of epigallocatechin gallate (EGCG). Each capsule, containing 125 mg EGCG, will be ingested after each meal. This is the standard dose in these kinds of green tea trials. The exercise/green tea group will ingest the green tea and perform the exercise.
Intervention code [1] 257295 0
Lifestyle
Intervention code [2] 257575 0
Prevention
Intervention code [3] 257576 0
Other interventions
Comparator / control treatment
The control group will have the same pre and posttesting carried out but will carry on with their daily lifestyle for 12 weeks. Diet will be assessed pre and post.
Control group
Active

Outcomes
Primary outcome [1] 259306 0
Body fat will be assessed by DEXA and two scans of computed tomography at St Vincents Hospital pre and post only. Bioimpedance (Tanita) will be used to monitor weekly body composition.
Timepoint [1] 259306 0
Pre and post after 12 weeks
Secondary outcome [1] 266268 0
Insulin resistance will be assessed by fasting insulin and glucose (HOMA). Bloods will be taken by qualified personnel at 0, 3, 6, and 12 weeks.
Timepoint [1] 266268 0
0, 3, 6, and 12 weeks.

Eligibility
Key inclusion criteria
Male, 18-35 years, BMI 25-30
Minimum age
18 Years
Maximum age
35 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Type 2 diabetes and cardiovascular disease (e.g., hypertension or any disease or condition that would prevent or impede regular participation in exercise. The eligible participants will be deemed healthy.

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)
A subject number (e.g., 1 for control, etc) will be randomly chosen from a box in a blinded manner.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Each subject number will be specific for a particular group: 1 = control, 2 = exercise only, 3 = exercise and green tea, and 4 = green tea only.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
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
5/01/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257730 0
Self funded/Unfunded
Name [1] 257730 0
Country [1] 257730 0
Australia
Primary sponsor type
University
Name
University New South Wales
Address
High Street
Randwick 2052
Sydney NSW
Country
Australia
Secondary sponsor category [1] 256946 0
None
Name [1] 256946 0
Address [1] 256946 0
Country [1] 256946 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 259785 0
Ethics committee address [1] 259785 0
Ethics committee country [1] 259785 0
Date submitted for ethics approval [1] 259785 0
04/10/2010
Approval date [1] 259785 0
Ethics approval number [1] 259785 0
10204

Summary
Brief summary
This project aims to determine if 12 weeks (three times per week) of high intensity intermittent exercise (HIIE) and green tea consumption leads to significant fat loss and improvements in metabolic markers for diabetes and cardiovascular disease in overweight men. We have shown that HIIE leads to significant fat loss and increase in insulin sensitivity in women and now want to demonstrate this effect in men. The ability of HIIE to increase catecholamline secretion may be the reason why this form of exercise combined with green tea consumption results in more fat loss compared to exercise such as walking and jogging.

We hypothesize that exposure to 12 weeks of HIIE and green tea will result in:
- significant subcutaneous and visceral fat loss
- significant increases in insulin sensitivity
- significant increases in aerobic and anaerobic fitness

We also hypothesize that:
- greater hepatic fat loss will occur when green tea is consumed with HIIE
Trial website
None
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 31710 0
Address 31710 0
Country 31710 0
Phone 31710 0
Fax 31710 0
Email 31710 0
Contact person for public queries
Name 14957 0
Steve Boutcher
Address 14957 0
University New South Wales
4 Arthur St
Randwick 2031
Sydney NSW
Country 14957 0
Australia
Phone 14957 0
+61 2 9385 2877
Fax 14957 0
Email 14957 0
[email protected]
Contact person for scientific queries
Name 5885 0
Steve Boutcher
Address 5885 0
University New South Wales
4 Arthur St
Randwick 2031
Sydney NSW
Country 5885 0
Australia
Phone 5885 0
+61 2 9385 2877
Fax 5885 0
Email 5885 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.