The Effects of Capsinoids on Brown Adipose Tissue Activation in Obesity
BATCAP
1 other identifier
interventional
19
1 country
1
Brief 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.
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 Apr 2017
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
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2017
CompletedFirst Posted
Study publicly available on registry
April 12, 2017
CompletedStudy Start
First participant enrolled
April 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 13, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 13, 2021
CompletedDecember 14, 2021
December 1, 2021
4.3 years
March 20, 2017
December 10, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
MRI BAT activity maps
Develop multi-parametric MRI BAT activity maps by comparing MRI measurements at thermo-neutral, non-shivering thermogenesis and warm-up conditions.
22 weeks
Study Arms (4)
BAT Positive Placebo
PLACEBO COMPARATORParticipants will be confirmed positive for BAT activity, but on Placebo
BAT Negative Placebo
PLACEBO COMPARATORParticipants will be confirmed negative for BAT activity, but on Placebo
BAT Positive Capsinoid
EXPERIMENTALParticipants will be confirmed positive for BAT activity, but taking Capsinoids. Capsinoids are a derivative of sweet peppers that may activate and recruit BAT.
BAT Negative Capsinoid
EXPERIMENTALParticipants will be confirmed negative for BAT activity, but taking Capsinoids. Capsinoids are a derivative of sweet peppers that may activate and recruit BAT.
Interventions
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.
Placebo for capsinoid. Capsule contains no active ingredients.
Eligibility Criteria
You may qualify if:
- Male.
- years old.
- Non-smoking.
- Overweight/Obese (BMI 27-45).
- Generally healthy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Northwestern University
Chicago, Illinois, 60611, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lisa M Neff, MD., MS.
Northwestern University Feinberg School of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor
Study Record Dates
First Submitted
March 20, 2017
First Posted
April 12, 2017
Study Start
April 17, 2017
Primary Completion
August 13, 2021
Study Completion
August 13, 2021
Last Updated
December 14, 2021
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share