NCT03110809

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 12, 2017

Completed
5 days until next milestone

Study Start

First participant enrolled

April 17, 2017

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 13, 2021

Completed
Last Updated

December 14, 2021

Status Verified

December 1, 2021

Enrollment Period

4.3 years

First QC Date

March 20, 2017

Last Update Submit

December 10, 2021

Conditions

Keywords

obesitybrownfatweightloss

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 COMPARATOR

Participants will be confirmed positive for BAT activity, but on Placebo

Dietary Supplement: Placebo

BAT Negative Placebo

PLACEBO COMPARATOR

Participants will be confirmed negative for BAT activity, but on Placebo

Dietary Supplement: Placebo

BAT Positive Capsinoid

EXPERIMENTAL

Participants will be confirmed positive for BAT activity, but taking Capsinoids. Capsinoids are a derivative of sweet peppers that may activate and recruit BAT.

Dietary Supplement: Capsinoid

BAT Negative Capsinoid

EXPERIMENTAL

Participants will be confirmed negative for BAT activity, but taking Capsinoids. Capsinoids are a derivative of sweet peppers that may activate and recruit BAT.

Dietary Supplement: Capsinoid

Interventions

CapsinoidDIETARY_SUPPLEMENT

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.

BAT Negative CapsinoidBAT Positive Capsinoid
PlaceboDIETARY_SUPPLEMENT

Placebo for capsinoid. Capsule contains no active ingredients.

BAT Negative PlaceboBAT Positive Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

MeSH Terms

Conditions

Weight LossObesityPlatelet Glycoprotein IV DeficiencyBody Weight

Condition Hierarchy (Ancestors)

Body Weight ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Lisa M Neff, MD., MS.

    Northwestern University Feinberg School of Medicine

    PRINCIPAL INVESTIGATOR

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

Locations