NCT02964442: TACTICAL-II

Brown Adipose Tissue Activation and Energy Expenditure by Capsinoids Stimulation With Trimodality Imaging Using 18-FDG-PET, Fat Fraction MRI and Infrared Thermography

Completed NA Last updated 10 May 2024

What this trial tests

NA trial testing Capsinoids in Brown Adipose Tissue in 30 participants. Completed in 24 October 2023.

Timeline

23 October 2015

Primary endpoint
24 October 2023

24 October 2023

Quick facts

Lead sponsor	Singapore Institute of Food and Biotechnology Innovation
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	other
Enrollment	30
Start date	23 October 2015
Primary completion	24 October 2023
Estimated completion	24 October 2023
Sites	1 location across Singapore

Drugs / interventions tested

• Capsinoids
• Cold Stimulus

Conditions studied

• Brown Adipose Tissue — all drugs for Brown Adipose Tissue →

Sponsor

Singapore Institute of Food and Biotechnology Innovation

Who can join

Adults 21 to 40, any sex, with Brown Adipose Tissue. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. The evolving view of thermogenic fat and its implications in cancer and metabolic diseases.
   Yin X, Chen Y, Ruze R, Xu R, et al · · 2022 · cited 43× · PMID 36114195 · DOI 10.1038/s41392-022-01178-6
2. 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.
   Sun L, Camps SG, Goh HJ, Govindharajulu P, et al · · 2018 · cited 42× · PMID 29381803 · DOI 10.1093/ajcn/nqx025
3. Brown Adipose Tissue: Multimodality Evaluation by PET, MRI, Infrared Thermography, and Whole-Body Calorimetry (TACTICAL-II).
   Sun L, Verma S, Michael N, Chan SP, et al · · 2019 · cited 35× · PMID 31301122 · DOI 10.1002/oby.22560
4. Fibroblast Growth Factor-21, Leptin, and Adiponectin Responses to Acute Cold-Induced Brown Adipose Tissue Activation.
   Sun L, Yan J, Goh HJ, Govindharajulu P, et al · · 2020 · cited 23× · PMID 31912874 · DOI 10.1210/clinem/dgaa005
5. A Feedforward Loop within the Thyroid-Brown Fat Axis Facilitates Thermoregulation.
   Sun L, Goh HJ, Govindharajulu P, Sun L, et al · · 2020 · cited 8× · PMID 32541662 · DOI 10.1038/s41598-020-66697-0
6. Activated brown adipose tissue releases exosomes containing mitochondrial methylene tetrahydrofolate dehydrogenase (NADP dependent) 1-like protein (MTHFD1L).
   Leow MK, Rengaraj A, Narasimhan K, Verma SK, et al · · 2022 · cited 7× · PMID 35502767 · DOI 10.1042/bsr20212543
7. Clinical Application Potential of Small Molecules that Induce Brown Adipose Tissue Thermogenesis by Improving Fat Metabolism.
   Lu KY, Primus Dass KT, Tsai SF, Chuang HM, et al · · 2020 · cited 2× · PMID 32854518 · DOI 10.1177/0963689720927394