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Capsaicin Energy Expenditure and Glucose Metabolism (CAPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03859583
Recruitment Status : Recruiting
First Posted : March 1, 2019
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
lilian de Jonge, George Mason University

Brief Summary:
The aim of the study is to investigate the effects of capsaicin rich foods on resting energy expenditure and substrate oxidation. We plan to recruit 30 healthy lean and overweight individuals age 18-45 (women) and age 18-50 (men) who will undergo two test days in random order. During one day they will receive a breakfast of toast, orange juice and an omelette with 4tsp of cayenne pepper while on the other day they will receive the same breakfast without the cayenne pepper. Metabolic rate and Respiratory quotients is measured for 30 minutes before the meal and for 2 hours after the meal. Capillary glucose levels and heart rate and blood pressure are measured before the meal and every 30 minutes thereafter for 2 hours.

Condition or disease Intervention/treatment Phase
Obesity Insulin Resistance Dietary Supplement: Capsaicin Dietary Supplement: Control Not Applicable

Detailed Description:

Participants will be recruited by posters distributed on campus bulletin boards and asked to contact the investigator by phone or e-mail. Participants will complete a screening questionnaire by phone to determine eligibility. Once they pass the screening, they will be invited to the laboratory to sign the consent form, which will be administered by Rafia Virk. They will also be given a demographic survey. The survey will inquire about height, weight, medical conditions, medications and inclusion/exclusion criteria and availability. This survey will be used for screening purposes only and will not contribute to the research data. The survey is included in this application and inclusion and exclusion criteria are outlined. If participants are determined eligible, they will be contacted to set up with two study visits, pre-test instructions will be provided.

*For both appointments, participants will arrive to the test location after a 12-hour fast.

Appointment 1: Participants will arrive at the Nutrition Assessment Laboratory between 7:00am and 7:30am. Details of the study will be re-iterated and informed consent will be obtained first thing on the morning of the first appointment. Eligibility will then then be confirmed by measuring height and weight and BMI calculation, and a over the counter pregnancy test will be performed on women. Demographic survey and 24-hour dietary recall will be obtained for 2 week days and 1 weekend day. Baseline measurements will then be obtained which include: Waist circumference, body compositition by Dual Energy X-ray Absorptiometry (DXA) scan (performed by Dr. de Jonge or Rafia Virk, who will be trained by Dr. de Jonge). The DXA scan involves lying on a table while wearing lose fitting, comfortable clothing. The scanner uses a low dose x-ray to determine the amount of fat, muscle and bone in your body. After lying down for 30 minutes, a metabolic cart will be used to measure resting energy expenditure by indirect calorimetry. For this procedure, a plastic dome will placed over the participants head that will measure their resting energy expenditure (REE). Baseline REE will then be measured for 30 minutes. After getting a baseline measure participants will consume a standard meal. We will continue to measure resting energy expenditure for 120 minutes. Blood glucose using a glucometer will also be determine before and 2 hours after the standardized meal. The REE measurements will be performed by Ms. Rafia Virk. Ms. Virk will be trained in the use of the metabolic cart by Dr. Lilian de Jonge who has over 20 years experience in the use of indirect calorimetry for the assessment of REE. After this test, the subjects will undergo a capsaicin threshold test. For this test, deionized water with red food coloring will serve as the blank. The testing compound will be cayenne pepper. The target samples, containing very low concentrations of cayenne pepper (0-1mg/g), will also have red food coloring so that they will only be distinguishable to participant by sense of taste rather than taste and sight. There will be nine sets of rows, each with 3 sets of samples. Each set will contain 2 blanks and one target sample. The target sample increase in concentration as the participant moves along the row. The participant will be asked to taste test the samples and pick the target sample out of the three. This appointment will take about 3 hours.

The second test day will occur within one week of the first day. The participant will arrive with a 12 hour fast during the first week of the study. They will consume the same standardized meal (provided by Dr. de Jonge) from first appointment but with the addition of capsaicin (cayenne pepper powder form) (4tsp). They will then undergo a metabolic cart test (120 mins). Their blood glucose will also be determined using a glucometer for the following 3 hours post consumption. This appointment will last about 3 hours.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Capsaicin Consumption on Resting Energy Expenditure and Glucose Metabolism
Actual Study Start Date : May 29, 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Capsaicin

Arm Intervention/treatment
Experimental: Capsaicin
4 tsp of cayenne pepper in a 60g omelette
Dietary Supplement: Capsaicin
4 tsp of cayenne in a breakfast omelette

Placebo Comparator: Control
60 g omelette
Dietary Supplement: Control
breakfast omelette without cayenne pepper




Primary Outcome Measures :
  1. Postprandial substrate oxidation [ Time Frame: 3 hours ]
    The change in substrate oxidation after a meal as measured by the ratio of carbondioxide production and oxygen consumption measured by indirect calorimetry


Secondary Outcome Measures :
  1. postprandial energy expenditure [ Time Frame: 3 hrs ]
    Change in resting energy expenditure after meal consumption as measured by indirect calorimetry



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18-45 years of age females or 18-50 males

    • Generally healthy non-diabetic overweight or obese men and women
    • BMI 23-33 kg/m2
    • Willing to abstain from caffeine and alcohol for 3 days prior to testing
    • Able to provide written consent in English
    • Ability to communicate in English (oral and written)

Exclusion Criteria:

  • BMI < 23 kg/m2 or >33 kg/m2

    • Pregnant or Nursing
    • Taking prescribed or over the counter medication affecting fluid balance or metabolism
    • Suffers from hepatic, renal, pulmonary, endocrine or hematological disease
    • Performs more than 3 hours a week of strenuous exercise
    • Consumes, on average, more than 2 alcoholic beverages per day
    • More than 5 kg of weight change over the past 6 months
    • Claustrophobic
    • Consumes capsaicin foods habitually 3x/week

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): NCT03859583


Contacts
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Contact: Elisabeth de Jonge, PhD 7039935153 edejonge@gmu.edu
Contact: Rafia VIrk, BSc 7039935153 rvirk@gmu.edu

Locations
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United States, Virginia
George Mason University Recruiting
Fairfax, Virginia, United States, 22030
Contact: Elisabeth de Jonge    703-993-5153    edejonge@gmu.edu   
Contact: Rafia Virk    7039935153    rvirk@gmu.edu   
Sponsors and Collaborators
George Mason University
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Responsible Party: lilian de Jonge, assistant professor, George Mason University
ClinicalTrials.gov Identifier: NCT03859583    
Other Study ID Numbers: 1157054-1
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 lilian de Jonge, George Mason University:
capsaicin
resting metabolic rate
glucose
Additional relevant MeSH terms:
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Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Capsaicin
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs