Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03110809 |
| Other study ID # |
SP0037287 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 17, 2017 |
| Est. completion date |
August 13, 2021 |
Study information
| Verified date |
December 2021 |
| Source |
Northwestern University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This research study is being done to determine whether taking a dietary supplement called
capsinoids, derived from sweet peppers, can activate brown fat that is already present or
even generate new brown fat in individuals with excess weight. Previous studies have
suggested that chronic consumption of capsinoids may be able to generate new brown fat in
thin individuals. Capsinoids may also have a small positive effect on metabolism (increased
calorie-burning) and fat loss. The knowledge gained in this study may eventually lead to more
treatment options for people with excess weight.
Description:
Obesity has become an epidemic in the United States, affecting more than one-third of
American adults and increasing the incidence of diabetes and other comorbidities. Weight loss
elicits adaptive metabolic and hormonal changes, similar to those seen in starvation, which
make maintenance of a reduced body weight more challenging. These changes include a decrease
in energy expenditure that is larger than what would be expected on the basis of changes in
body composition alone. In rodents, it has long been established that brown adipose tissue
(BAT) is the primary site of adaptive thermogenesis or the modulation of energy expenditure
and heat generation during cold exposure and overfeeding. Emerging data suggest that
activated BAT may influence body weight, core body temperature, energy expenditure and blood
sugar and fat metabolism in humans. Capsinoids are nunpungent analogs of capsaicin that
activate BAT by stimulating sensory neurons in the gastrointestinal tract. Chronic ingestion
of capsinoids may stimulate the development or recruitment of new BAT from precursor stem
cells within white adipose tissue depots. The primary goal of the proposed study is to
determine whether chronic ingestion of capsinoids can recruit BAT in obese individuals who
lack it or merely activates BAT in those who already have it. Additional goals are to 1)
ascertain whether common genetic variants influence the response to capsinoids, 2) determine
the metabolic effects of chronic capsinoid ingestion and BAT activation in obesity without
weight loss and 3) establish whether chronic capsinoid ingestion and BAT activation improve
weight loss with a low calorie diet. 42 obese male volunteers, ages 18-50, will be recruited
for a randomized, double-blind, placebo-controlled trial of capsinoid supplementation. The
study will consist of two phases: the first in which subjects maintain their usual diet and
activity level for 8 weeks, and the second in which subjects consume a low-calorie diet for
12 weeks. Subjects will be studied before and after each phase, including measurement of BAT,
core body temperature, energy expenditure at rest, after cold exposure, and after a test
meal, body composition, and blood sugar and insulin levels after a test meal. BAT will be
characterized using Positron Emission Tomography/Magnetic Resonance (PET/MR) and Magnetic
Resonance Imaging (MRI) techniques. If preliminary data are confirmed, BAT recruitment and
activation through chronic capsinoid supplementation may emerge as a safe method to combat
the adaptive changes in energy expenditure that are seen with weight loss in obesity.
