ObesityNCT01961674
Studying the Effect of Capsinoids on Brown Fat Using Infrared Thermal Imaging.
A study of Obesity and Diabetes, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
Trial summary
The primary hypothesis of this study is that consumption of capsinoids increases brown adipose tissue activity, detectable by infrared thermal imaging. The secondary hypothesis is that consumption of capsinoids can affect an individual's glycaemic response. Read more about this study
- Who is it for?
- Ages 21 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Diabetes, Impaired Glucose Tolerance
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSingapore
- Study dates
- Nov 2013to Jul 2014
- 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 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Chinese ethnicity
- Male
- Healthy
- Age 21 - 30 years
- BMI 18.0 - 22.9 kg/m2
- Not on any prescribed medication
- Infrequent spicy food or chilli user (less than 3 times per week)
Who cannot join
- Smoker
- Fasting blood glucose > 5.5 mmol/L
- Resting blood pressure > 140/90 mmHg
- Any major medical conditions including diabetes, hypertension, cardiovascular disease, thyroid disorders
- Allergic or intolerant to foods presented in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Infrared Thermal Imaging for Assessing the Effect of Capsinoids on Brown Adipose Tissue Activity.
The primary hypothesis of this study is that consumption of capsinoids increases brown adipose tissue activity, detectable by infrared thermal imaging.
The secondary hypothesis is that consumption of capsinoids can affect an individual's glycaemic response.
Read the detailed description
It has been recently established that brown adipose tissue (BAT) exists in adult humans. BAT is a thermogenic tissue which dissipates energy as heat. The primary objective of this study is to use thermal imaging to assess the effect of capsinoids on BAT activity in adult humans, and whether there is a relationship between the increase in energy expenditure and BAT activity after capsinoids intake. The secondary objective is to investigate whether capsinoids will have an effect on an individual's glycaemic response. Lean, healthy male volunteers will be recruited. There will be two test sessions which are randomized, where subjects will consume either capsinoids or placebo capsules, and a standardized amount of white rice (equivalent to 50g carbohydrates). Indirect calorimetry will be used to assess energy expenditure before and after consumption of the test meal. Thermal imaging of supraclavicular BAT, the primary BAT depot in humans, will be undertaken using an infrared thermal camera to assess changes in BAT temperature. Blood glucose levels will be monitored by finger prick blood sampling method. This study aims to investigate whether capsinoids consumption leads to changes in BAT temperatures detectable by the infrared thermal camera, to confirm the feasibility of using thermal imaging as a rapid, noninvasive, and reproducible way of studying BAT activity thus providing a platform to advance research in this emerging field of human BAT.
- Conditions
- Obesity, Diabetes, Impaired Glucose Tolerance
- Being tested
- Capsinoid/placebo and rice
- Medical subject headings
- Obesity, Diabetes Mellitus, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsinoid/placebo and riceDietary supplement
The subject will ingest six capsinoid/placebo capsules and a standardized amount of white rice (equivalent to 50g carbohydrates). Each capsule consists 1.5mg of capsinoids, making a total dose of 9mg capsinoids.
| Study group | Role | What they receive |
|---|---|---|
| Capsinoid arm | Experimental | On capsinoids Receives: Dietary Supplement: Capsinoid/placebo and rice |
| Placebo arm | Placebo comparator | Placebo Receives: Dietary Supplement: Capsinoid/placebo and rice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temperature at supraclavicular region
The temperature at the supraclavicular region following consumption of capsinoids will be determined using infrared thermal imaging.
Measured: 2.5 hours post-consumption
Secondary outcomes (1)
Glycaemic response
The blood glucose response to capsinoids measured over 2.5 hours following their consumption.
Measured: 2.5 hours post-consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2013 (estimated)
- Study startNov 2013
- Primary completionJul 2014
- Study completionJul 2014
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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore Institute of Food and Biotechnology Innovation
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Melvin Leow, Singapore Institute of Food and Biotechnology Innovation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01961674
- Sponsor's protocol ID
- 2013/00785
- Status last verified
- Feb 2016
- First submitted
- 10 Oct 2013
- Last updated
- 2 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infrared Thermal Imaging for Assessing the Effect of Capsinoids on Brown Adipose Tissue Activity.
- ClinicalTrials.gov ID
- NCT01961674
- Acronym / sponsor ID
- 2013/00785
- Conditions
- Obesity, Diabetes, Impaired Glucose Tolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Singapore Institute of Food and Biotechnology InnovationOther government
- Study start
- Nov 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 11 Oct 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.
The primary hypothesis of this study is that consumption of capsinoids increases brown adipose tissue activity, detectable by infrared thermal imaging.
The secondary hypothesis is that consumption of capsinoids can affect an individual's glycaemic response.
Detailed description
It has been recently established that brown adipose tissue (BAT) exists in adult humans. BAT is a thermogenic tissue which dissipates energy as heat. The primary objective of this study is to use thermal imaging to assess the effect of capsinoids on BAT activity in adult humans, and whether there is a relationship between the increase in energy expenditure and BAT activity after capsinoids intake. The secondary objective is to investigate whether capsinoids will have an effect on an individual's glycaemic response. Lean, healthy male volunteers will be recruited. There will be two test sessions which are randomized, where subjects will consume either capsinoids or placebo capsules, and a standardized amount of white rice (equivalent to 50g carbohydrates). Indirect calorimetry will be used to assess energy expenditure before and after consumption of the test meal. Thermal imaging of supraclavicular BAT, the primary BAT depot in humans, will be undertaken using an infrared thermal camera to assess changes in BAT temperature. Blood glucose levels will be monitored by finger prick blood sampling method. This study aims to investigate whether capsinoids consumption leads to changes in BAT temperatures detectable by the infrared thermal camera, to confirm the feasibility of using thermal imaging as a rapid, noninvasive, and reproducible way of studying BAT activity thus providing a platform to advance research in this emerging field of human BAT.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capsinoid arm | Experimental | Dietary Supplement: Capsinoid/placebo and riceOn capsinoids |
| Placebo arm | Placebo comparator | Dietary Supplement: Capsinoid/placebo and ricePlacebo |
Who may qualify
- Ages
- 21 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Chinese ethnicity
- Male
- Healthy
- Age 21 - 30 years
- BMI 18.0 - 22.9 kg/m2
Key exclusion criteria (5 listed)
- Smoker
- Fasting blood glucose > 5.5 mmol/L
- Resting blood pressure > 140/90 mmHg
- Any major medical conditions including diabetes, hypertension, cardiovascular disease, thyroid disorders
- Allergic or intolerant to foods presented in the study
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 |
|---|---|---|
| Capsinoid/placebo and riceThe subject will ingest six capsinoid/placebo capsules and a standardized amount of white rice (equivalent to 50g carbohydrates). Each capsule consists 1.5mg of capsinoids, making a total dose of 9mg capsinoids. | Dietary supplement | Capsinoid arm, Placebo arm |
Primary outcome
Temperature at supraclavicular region
Time frame: 2.5 hours post-consumption
The temperature at the supraclavicular region following consumption of capsinoids will be determined using infrared thermal imaging.
1 secondary outcome
Glycaemic response
Time frame: 2.5 hours post-consumption
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 2 Feb 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Obesity and Diabetes, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
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 7 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: finished, as of the sponsor's last update on 2 Feb 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 Singapore. 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 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 supraclavicular region (time frame: 2.5 hours post-consumption). 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 2 Feb 2016.