Brown Adipose Tissue Activation and Energy Expenditure by Capsinoids Stimulation With Trimodality Imaging Using 18-FDG-PET, Fat Fraction MRI and Infrared Thermography
TACTICAL-II
1 other identifier
interventional
30
1 country
1
Brief Summary
Brown adipose tissue (BAT) thermogenesis can be assessed by IR thermography, the accompanying increase metabolic rate can be measured by whole body calorimetry and BAT volume can be precisely measured by MRI. The aim of the study is to validate IRT for BAT thermogenesis against the present gold standard 18-FDG-PET scan, quantify BAT volume by fat fraction MRI and measure the accompanying increase in BMR by whole body calorimetry among healthy euthyroid subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 23, 2015
CompletedFirst Submitted
Initial submission to the registry
November 4, 2016
CompletedFirst Posted
Study publicly available on registry
November 16, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 24, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 24, 2023
CompletedMay 10, 2024
May 1, 2024
8 years
November 4, 2016
May 9, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
Brown adipose tissue activation detection by Imaging using 18-FDG-PET/ MRI.
post consumption of capsinoids capsules for 2 hours
Energy Expenditure using Whole Body Calorimeter.
post consumption of capsinoids capsules for 2 hours
Brown adipose tissue activation detection by Imaging using Infrared Thermography.
post consumption of capsinoids capsules for 2 hours
Secondary Outcomes (3)
Brown adipose tissue activation detection by Imaging using 18-FDG-PET/ MRI.
post cold stimulus up to 2 hours
Energy Expenditure using Whole Body Calorimeter.
To measure cold stimulus for 2 hours
Brown adipose tissue activation detection by Imaging using Infrared Thermography.
post cold stimulus up to 2 hours
Study Arms (2)
Capsinoids
EXPERIMENTAL8 gel capsules equivalent to 12mg
Cooling Vest
EXPERIMENTALUsing Cooling vest (at approxiamately14 degrees Celsius) to cool the body.
Interventions
Eligibility Criteria
You may qualify if:
- Overtly healthy with no past history of chronic illnesses
- Aged 21-40 years old Male and female gender
- BMI from 18.5 to 29.9 kg/m2 inclusive
- No prior history of thyroid disease.
- Euthyroid biochemically with FT4 and TSH in the normal ranges
You may not qualify if:
- Recent changes in weight of \>5% over the past 6 months.
- Attempts to lose weight over the past 6 months.
- Significant changes in diet over the past 6 months.
- Any use of weight reducing drugs in the past 6 months.
- Previous weight reducing surgery.
- Any use of investigational drugs in the past 6 months.
- Subclinical thyroid dysfunction based on thyroid function test.
- Chronic illnesses such as diabetes mellitus or cancer.
- You have a known history of thyroid, liver or kidney disease.
- Use of any prescription medication that cannot be safely discontinued within 14 days prior to study entry.
- Female subjects who are pregnant.
- Oral medications affecting brown fat activity (eg. alpha agonists or blockers, beta agonists or blockers, sympatholytic agents) which the researchers will clarify with you.
- Chronic topical ointment with menthol or capsaicin or use of nasal decongestants.
- History of surgery with metallic clips, staples or stents.
- Presence of cardiac pacemaker or other foreign body in any part of the body.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Nutrition Research Centre
Singapore, 117599, Singapore
Related Publications (3)
Sun L, Yan J, Goh HJ, Govindharajulu P, Verma S, Michael N, Sadananthan SA, Henry CJ, Velan SS, Leow MK. Fibroblast Growth Factor-21, Leptin, and Adiponectin Responses to Acute Cold-Induced Brown Adipose Tissue Activation. J Clin Endocrinol Metab. 2020 Mar 1;105(3):e520-31. doi: 10.1210/clinem/dgaa005.
PMID: 31912874DERIVEDSun L, Verma S, Michael N, Chan SP, Yan J, Sadananthan SA, Camps SG, Goh HJ, Govindharajulu P, Totman J, Townsend D, Goh JP, Sun L, Boehm BO, Lim SC, Sze SK, Henry CJ, Hu HH, Velan SS, Leow MK. Brown Adipose Tissue: Multimodality Evaluation by PET, MRI, Infrared Thermography, and Whole-Body Calorimetry (TACTICAL-II). Obesity (Silver Spring). 2019 Sep;27(9):1434-1442. doi: 10.1002/oby.22560. Epub 2019 Jul 13.
PMID: 31301122DERIVEDSun L, Camps SG, Goh HJ, Govindharajulu P, Schaefferkoetter JD, Townsend DW, Verma SK, Velan SS, Sun L, Sze SK, Lim SC, Boehm BO, Henry CJ, Leow MK. Capsinoids activate brown adipose tissue (BAT) with increased energy expenditure associated with subthreshold 18-fluorine fluorodeoxyglucose uptake in BAT-positive humans confirmed by positron emission tomography scan. Am J Clin Nutr. 2018 Jan 1;107(1):62-70. doi: 10.1093/ajcn/nqx025.
PMID: 29381803DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 4, 2016
First Posted
November 16, 2016
Study Start
October 23, 2015
Primary Completion
October 24, 2023
Study Completion
October 24, 2023
Last Updated
May 10, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share