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The Effects of Capsinoids on Brown Adipose Tissue Activation in Obesity (BATCAP)

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ClinicalTrials.gov Identifier: NCT03110809
Recruitment Status : Recruiting
First Posted : April 12, 2017
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Lisa Neff, Northwestern University

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.

Condition or disease Intervention/treatment Phase
Weight Loss Dietary Supplement: Capsinoid Dietary Supplement: Placebo Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Official Title: The Effects of Capsinoids on Brown Adipose Tissue Recruitment and Activation in Obesity
Actual Study Start Date : April 17, 2017
Estimated Primary Completion Date : February 15, 2021
Estimated Study Completion Date : December 31, 2021

Arm Intervention/treatment
Placebo Comparator: BAT Positive Placebo
Participants will be confirmed positive for BAT activity, but on Placebo
Dietary Supplement: Placebo
Placebo for capsinoid. Capsule contains no active ingredients.

Placebo Comparator: BAT Negative Placebo
Participants will be confirmed negative for BAT activity, but on Placebo
Dietary Supplement: Placebo
Placebo for capsinoid. Capsule contains no active ingredients.

Experimental: BAT Positive Capsinoid
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
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.

Experimental: BAT Negative Capsinoid
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
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.




Primary Outcome Measures :
  1. MRI BAT activity maps [ Time Frame: 22 weeks ]
    Develop multi-parametric MRI BAT activity maps by comparing MRI measurements at thermo-neutral, non-shivering thermogenesis and warm-up conditions.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male.
  • 18-50 years old.
  • Non-smoking.
  • Overweight/Obese (BMI 27-45).
  • Generally healthy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03110809


Contacts
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Contact: Beth Hakamy, MBBS 312-503-7203 beth.hakamy@northwestern.edu

Locations
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United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Beth Hakamy    312-503-7203      
Principal Investigator: Lisa M Neff, MD, MS         
Principal Investigator: Jie Deng, PhD         
Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: Lisa M Neff, MD., MS. Northwestern University Feinberg School of Medicine

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Responsible Party: Lisa Neff, Medical Doctor, Northwestern University
ClinicalTrials.gov Identifier: NCT03110809     History of Changes
Other Study ID Numbers: SP0037287
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lisa Neff, Northwestern University:
obesity
brown
fat
weight
loss
Additional relevant MeSH terms:
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Obesity
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes