Energy ExpenditureBRIGHTNCT02790255
BRown Fat Activity Measurement With Infrared imaginG tHermography andThermogenesis - the BRIGHT Study
A study testing Cold air and Cold water in people with Energy Expenditure and Obesity, run by Singapore Institute of Food and Biotechnology Innovation.
Trial summary
The whole body calorimeter is sensitive enough to reliably measure cold-induced thermogenesis as a surrogate marker of brown adipose tissue (BAT) activation. The infrared (IR) energy flux from activated BAT can be accurately imaged and quantified using an IR imaging device, and that this IR energy output may be… Read more about this study
- Who is it for?
- Ages 21 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Energy Expenditure, Obesity, Adipose Tissue, Brown
- What is being tested?
- Cold air and Cold water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to 5 Nov 2018
- 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 21 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Ethnic Chinese
- Age between 21 to 35 years
- Body Mass Index 18.5 to 22.9
- Normal resting blood pressure ~120/80 mmHg
- Normal fasting blood glucose level <5.5 mmol/L
Who cannot join
- Do not train for or partake in competitive sports
- Do not have any major diseases
- Not on any prescribed medication
About this study
Official title: BRown Fat Activity Measurement With Infrared imaginG tHermography and Thermogenesis - the BRIGHT Study
The whole body calorimeter is sensitive enough to reliably measure cold-induced thermogenesis as a surrogate marker of brown adipose tissue (BAT) activation.
The infrared (IR) energy flux from activated BAT can be accurately imaged and quantified using an IR imaging device, and that this IR energy output may be correlated to the increased energy expenditure quantified by the whole body calorimeter.
Read the detailed description
The recent rediscovery of functional brown adipose tissue (BAT) in healthy adults has opened up the exciting possibility of manipulating BAT for obesity management, and it is imperative to develop BAT imaging modalities that are non-invasive and safe for repeated use. Given that heat is a specific end-product of uncoupling protein-1 (UCP-1)-mediated BAT, this study examines whether surface body temperature assessed using infrared (IR) thermography can be a non-invasive measure to accurately and precisely predict brown adipose tissue (BAT) activation upon cold stimulation, which involves verifying an semi-automated method for characterizing thermal images. In addition, this study also aims to validate the use of a whole-body calorimeter to pick up changes in energy expenditure upon cold-induced thermogenesis. Lean, healthy male volunteers will be recruited. Thermal imaging of cervical-supraclavicular BAT will be done using an IR camera to assess changes in BAT activation. Blood samples will also be drawn at regular intervals to track changes in serum metabolites upon BAT activation. All in all, this study hopes to provide more supporting evidence that IR thermography is a viable imaging modality that is non-invasive, safe and reproducible of studying BAT activity.
- Conditions
- Energy Expenditure, Obesity, Adipose Tissue, Brown
- Being tested
- Cold air, Cold water
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold airOther
Cold waterOther
| Study group | Role | What they receive |
|---|---|---|
| Cold air | Experimental | Subjects to be seated in an airtight chamber at an ambient temperature between 16 to 20 degrees Celsius for 1 hour. Receives: Other: Cold air |
| Cold water | Experimental | Subjects to be seated in an airtight chamber at an ambient temperature of 24 degrees Celsius, with their hands and feet fully immersed in cold water for 5 minutes. Receives: Other: Cold water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temperature at cervical-supraclavicular region
The temperature at the cervical-supraclavicular region following cold exposure will be determined using infrared thermal imaging.
Measured: 45 minutes cold exposure
Secondary outcomes (1)
Energy expenditure during cold exposure
Energy expenditure during cold exposure will be determined using the whole-body calorimeter.
Measured: 45 minutes cold exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2016 (estimated)
- Study startNov 2014
- Primary completion5 Nov 2018
- Study completion5 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Energy ExpenditureStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore Institute of Food and Biotechnology Innovation
- Sponsor type
- Other government
- Collaborators
- Institute for Infocomm Research
- Responsible party
- Principal investigator, Melvin Leow, Singapore Institute of Food and Biotechnology Innovation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02790255
- Sponsor's protocol ID
- 2014/00721
- Other IDs
- 2014
- Acronym
- BRIGHT
- Status last verified
- May 2019
- First submitted
- 31 May 2016
- Last updated
- 15 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BRown Fat Activity Measurement With Infrared imaginG tHermography and Thermogenesis - the BRIGHT Study
- ClinicalTrials.gov ID
- NCT02790255
- Acronym / sponsor ID
- BRIGHT / 2014/00721
- Conditions
- Energy Expenditure, Obesity, Adipose Tissue, Brown
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Singapore Institute of Food and Biotechnology InnovationOther government
- Collaborators
- Institute for Infocomm Research
- Study start
- Nov 2014
- Primary completion
- 5 Nov 2018 (actual)
- Study completion
- 5 Nov 2018 (actual)
- First posted
- 3 Jun 2016 (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.
The whole body calorimeter is sensitive enough to reliably measure cold-induced thermogenesis as a surrogate marker of brown adipose tissue (BAT) activation.
The infrared (IR) energy flux from activated BAT can be accurately imaged and quantified using an IR imaging device, and that this IR energy output may be correlated to the increased energy expenditure quantified by the whole body calorimeter.
Detailed description
The recent rediscovery of functional brown adipose tissue (BAT) in healthy adults has opened up the exciting possibility of manipulating BAT for obesity management, and it is imperative to develop BAT imaging modalities that are non-invasive and safe for repeated use. Given that heat is a specific end-product of uncoupling protein-1 (UCP-1)-mediated BAT, this study examines whether surface body temperature assessed using infrared (IR) thermography can be a non-invasive measure to accurately and precisely predict brown adipose tissue (BAT) activation upon cold stimulation, which involves verifying an semi-automated method for characterizing thermal images. In addition, this study also aims to validate the use of a whole-body calorimeter to pick up changes in energy expenditure upon cold-induced thermogenesis. Lean, healthy male volunteers will be recruited. Thermal imaging of cervical-supraclavicular BAT will be done using an IR camera to assess changes in BAT activation. Blood samples will also be drawn at regular intervals to track changes in serum metabolites upon BAT activation. All in all, this study hopes to provide more supporting evidence that IR thermography is a viable imaging modality that is non-invasive, safe and reproducible of studying BAT activity.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cold air | Experimental | Other: Cold airSubjects to be seated in an airtight chamber at an ambient temperature between 16 to 20 degrees Celsius for 1 hour. |
| Cold water | Experimental | Other: Cold waterSubjects to be seated in an airtight chamber at an ambient temperature of 24 degrees Celsius, with their hands and feet fully immersed in cold water for 5 minutes. |
Who may qualify
- Ages
- 21 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male
- Ethnic Chinese
- Age between 21 to 35 years
- Body Mass Index 18.5 to 22.9
- Normal resting blood pressure ~120/80 mmHg
Key exclusion criteria (3 listed)
- Do not train for or partake in competitive sports
- Do not have any major diseases
- Not on any prescribed medication
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 |
|---|---|---|
| Cold air | Other | Cold air |
| Cold water | Other | Cold water |
Primary outcome
Temperature at cervical-supraclavicular region
Time frame: 45 minutes cold exposure
The temperature at the cervical-supraclavicular region following cold exposure will be determined using infrared thermal imaging.
1 secondary outcome
Energy expenditure during cold exposure
Time frame: 45 minutes cold exposure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Cold air and Cold water in people with Energy Expenditure and Obesity, run by Singapore Institute of Food and Biotechnology Innovation.
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 6 inclusion and 3 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: finished, as of the sponsor's last update on 15 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Temperature at cervical-supraclavicular region (time frame: 45 minutes cold exposure). 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 May 2019.