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ObesityCAPSNCT03859583

Capsaicin Energy Expenditure and Glucose Metabolism

A study testing Capsaicin in people with Obesity and Insulin Resistance, run by George Mason University at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Insulin Resistance
What is being tested?
Capsaicin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteUnited States
Study dates
29 May 2018to Aug 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 9Show fewer
  • More than 5 kg of weight change over the past 6 months
  • Claustrophobic
  • Consumes capsaicin foods habitually 3x/week

Trial locations and contacts

1 site in 1 country.

Elisabeth de Jonge, PhD contact

7039935153

edejonge@gmu.edu

Rafia VIrk, BSc contact

7039935153

rvirk@gmu.edu

United States1 site, 1 recruiting
  • George Mason University

    Fairfax, Virginia, 22030

    Elisabeth de Jonge, 703-993-5153, edejonge@gmu.edu

    Rafia Virk, 7039935153, rvirk@gmu.edu

    Recruiting

Other trials in United States

About this study

Official title: Capsaicin Consumption on Resting Energy Expenditure and Glucose Metabolism

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.

Read the 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.

Being tested
Capsaicin, Control
Keywords
capsaicin, resting metabolic rate, glucose
Medical subject headings
Obesity, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CapsaicinDietary supplement

    4 tsp of cayenne in a breakfast omelette

  • ControlDietary supplement

    breakfast omelette without cayenne pepper

Study groups in NCT03859583
Study groupRoleWhat they receive
CapsaicinExperimental4 tsp of cayenne pepper in a 60g omelette
Receives: Dietary Supplement: Capsaicin
ControlPlacebo comparator60 g omelette
Receives: Dietary Supplement: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postprandial substrate oxidation

    The change in substrate oxidation after a meal as measured by the ratio of carbondioxide production and oxygen consumption measured by indirect calorimetry

    Measured: 3 hours

Secondary outcomes (1)
  1. postprandial energy expenditure

    Change in resting energy expenditure after meal consumption as measured by indirect calorimetry

    Measured: 3 hrs

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2019
  2. Study start29 May 2018
  3. Primary completionAug 2019 (estimated)
  4. Study completionAug 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03859583
Sponsor's protocol ID
1157054-1
Acronym
CAPS
Status last verified
Feb 2019
First submitted
27 Feb 2019
Last updated
1 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Capsaicin in people with Obesity and Insulin Resistance, run by George Mason University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Elisabeth de Jonge, PhD (7039935153, edejonge@gmu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postprandial substrate oxidation (time frame: 3 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2019.

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