- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01961674
Studying the Effect of Capsinoids on Brown Fat Using Infrared Thermal Imaging.
February 1, 2016 updated by: Melvin Leow, Clinical Nutrition Research Centre, Singapore
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Singapore, Singapore, 117599
- Clinical Nutrition Research Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 30 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Capsinoid arm
On capsinoids
|
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.
|
|
PLACEBO_COMPARATOR: Placebo arm
Placebo
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
2.5 hours post-consumption
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Glycaemic response
Time Frame: 2.5 hours post-consumption
|
The blood glucose response to capsinoids measured over 2.5 hours following their consumption.
|
2.5 hours post-consumption
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2013
Primary Completion (ACTUAL)
July 1, 2014
Study Completion (ACTUAL)
July 1, 2014
Study Registration Dates
First Submitted
October 10, 2013
First Submitted That Met QC Criteria
October 10, 2013
First Posted (ESTIMATE)
October 11, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
February 2, 2016
Last Update Submitted That Met QC Criteria
February 1, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013/00785
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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