Studying the Effect of Capsinoids on Brown Fat Using Infrared Thermal Imaging.

Obesity Clinical Trial

Official title:

Infrared Thermal Imaging for Assessing the Effect of Capsinoids on Brown Adipose Tissue Activity.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01961674
• Other study ID #: 2013/00785
• Status: Completed
• Phase: N/A
• First received: October 10, 2013
• Last updated: February 1, 2016
• Start date: November 2013
• Est. completion date: July 2014

Study information

• Verified date: February 2016
• Source: Clinical Nutrition Research Centre, Singapore
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Domain Specific Review Boards
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 30 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Diabetes
• Glucose Intolerance
• Impaired Glucose Tolerance
• Obesity

Intervention

Dietary Supplement:
• Capsinoid/placebo and rice
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.

Locations

Country	Name	City	State
Singapore	Clinical Nutrition Research Centre	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Nutrition Research Centre, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Temperature at supraclavicular region	The temperature at the supraclavicular region following consumption of capsinoids will be determined using infrared thermal imaging.	2.5 hours post-consumption	No
Secondary	Glycaemic response	The blood glucose response to capsinoids measured over 2.5 hours following their consumption.	2.5 hours post-consumption	No