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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01974778




Registration number
NCT01974778
Ethics application status
Date submitted
23/10/2013
Date registered
3/11/2013
Date last updated
15/01/2016

Titles & IDs
Public title
A Role for Brown Adipose Tissue in Postprandial Thermogenesis?
Scientific title
A Role for Brown Adipose Tissue in Postprandial Thermogenesis?
Secondary ID [1] 0 0
345-13
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Diabetes 0 0
Cardiovascular Disease 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Meal

Experimental: Active - Meal

Placebo Comparator: Control - Water


Other interventions: Meal
Meal
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
BAT activity
Timepoint [1] 0 0
2 years

Eligibility
Key inclusion criteria
- Males aged 19 - 35 years

- Unmedicated for the previous 2 months

- No major illness

- BMI 17-40 kg/m2
Minimum age
19 Years
Maximum age
35 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Unable to give informed consent

- Smokers

- Participant in research projects involving ionising radiation within the past 5 years,
excluding dual energy x-ray absorptiometry scans conducted in prior studies

- Claustrophobia

- Fasting plasma glucose > 6.0 mmol/L

Study design
Purpose of the study
Basic Science
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2015
Sample size
Target
Accrual to date
Final
4
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Bayside Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Brown adipose (fat) tissue (BAT) is a type of fat tissue found in certain small rodents and
human babies that is capable of extremely high rates of energy burning. We now know that in
adult humans it is present and also able to burn energy.

In addition to increased energy expenditure during cold exposure, energy burning is also
increased after consuming a meal. Animal studies have shown that part of this additional
energy consumption is contributed by BAT. In the present study we will aim to examine whether
BAT activity is increased after a meal.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01974778
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bronwyn Kingwell, Professor
Address 0 0
Baker IDI Heart & Diabetes Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01974778