ObesityNCT01974778
A Role for Brown Adipose Tissue in Postprandial Thermogenesis?
A study testing Meal in people with Obesity and Diabetes, run by Bayside Health at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Diabetes, Cardiovascular Disease
- What is being tested?
- Meal
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteAustralia
- Study dates
- Mar 2014to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males aged 19 - 35 years
- Unmedicated for the previous 2 months
- No major illness
- BMI 17-40 kg/m2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
The purpose of this project is to measure whether BAT activity (during which BAT increases energy burning) increases in response to ingestion of a meal.
BAT is one of two types of fat, (the other being white fat), which is found in humans and other mammals. In this study we aim to further our understanding of how BAT works in humans. Studies in animals show that in addition to cold exposure, BAT is also activated by ingestion of a meal, and to different amounts depending on the meal composition, and more importantly, total energy content. However we have only a very limited understanding of BAT function in response to meals in humans. Since BAT function is defective in obesity, and its activity and function are impacted by diet, here we will find out whether a single high energy meal composed entirely of lipid (fat) can increase BAT activity. In future these findings and those of subsequent studies may have important implications for the management of obesity and related diseases.
A total of 20 people will participate in this project. Participation will involve a total of 3 visits, including a screening visit, 2 experimental visits consumption of the treatment meal on one visit, and the placebo (dummy) on the other in a randomised order.
- Conditions
- Obesity, Diabetes, Cardiovascular Disease
- Being tested
- Meal
- Medical subject headings
- Obesity, Diabetes Mellitus, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MealDietary supplement
Meal
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Meal Receives: Dietary Supplement: Meal |
| Control | Placebo comparator | Water Receives: Dietary Supplement: Meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
BAT activity
Analysis of PET/CT scans
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2013 (estimated)
- Study startMar 2014
- Primary completionAug 2015
- Study completionAug 2015
Why it stopped: Participant numbers too low. Could not ingest required fat.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayside Health
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ms. Rowan Frew, Bayside Health
- Investigators
- Bronwyn Kingwell, Professor, Principal investigator, Baker IDI Heart & Diabetes Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01974778
- Sponsor's protocol ID
- 345-13
- Status last verified
- Jan 2016
- First submitted
- 23 Oct 2013
- Last updated
- 15 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Role for Brown Adipose Tissue in Postprandial Thermogenesis?
- ClinicalTrials.gov ID
- NCT01974778
- Acronym / sponsor ID
- 345-13
- Conditions
- Obesity, Diabetes, Cardiovascular Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Participant numbers too low. Could not ingest required fat.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Bayside HealthOther government
- Study start
- Mar 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 4 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this project is to measure whether BAT activity (during which BAT increases energy burning) increases in response to ingestion of a meal.
BAT is one of two types of fat, (the other being white fat), which is found in humans and other mammals. In this study we aim to further our understanding of how BAT works in humans. Studies in animals show that in addition to cold exposure, BAT is also activated by ingestion of a meal, and to different amounts depending on the meal composition, and more importantly, total energy content. However we have only a very limited understanding of BAT function in response to meals in humans. Since BAT function is defective in obesity, and its activity and function are impacted by diet, here we will find out whether a single high energy meal composed entirely of lipid (fat) can increase BAT activity. In future these findings and those of subsequent studies may have important implications for the management of obesity and related diseases.
A total of 20 people will participate in this project. Participation will involve a total of 3 visits, including a screening visit, 2 experimental visits consumption of the treatment meal on one visit, and the placebo (dummy) on the other in a randomised order.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Dietary Supplement: MealMeal |
| Control | Placebo comparator | Dietary Supplement: MealWater |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Males aged 19 - 35 years
- Unmedicated for the previous 2 months
- No major illness
- BMI 17-40 kg/m2
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MealMeal | Dietary supplement | Active, Control |
Primary outcome
BAT activity
Time frame: 2 years
Analysis of PET/CT scans
Results and safety
The study was stopped early (reason given: Participant numbers too low. Could not ingest required fat.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bronwyn Kingwell, Professor principal investigator
Baker IDI Heart & Diabetes Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meal in people with Obesity and Diabetes, run by Bayside Health at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Participant numbers too low. Could not ingest required fat.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BAT activity (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2016.