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.
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.
United States1 site, 1 recruiting
- Recruiting
George Mason University
Fairfax, Virginia, 22030
Elisabeth de Jonge, 703-993-5153, edejonge@gmu.edu
Rafia Virk, 7039935153, rvirk@gmu.edu
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.
- Conditions
- Obesity, Insulin Resistance
- 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 group | Role | What they receive |
|---|---|---|
| Capsaicin | Experimental | 4 tsp of cayenne pepper in a 60g omelette Receives: Dietary Supplement: Capsaicin |
| Control | Placebo comparator | 60 g omelette Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted1 Mar 2019
- Study start29 May 2018
- Primary completionAug 2019 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- George Mason University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, lilian de Jonge, George Mason University
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capsaicin Consumption on Resting Energy Expenditure and Glucose Metabolism
- ClinicalTrials.gov ID
- NCT03859583
- Acronym / sponsor ID
- CAPS / 1157054-1
- Conditions
- Obesity, Insulin Resistance
- Keywords
- capsaicin, resting metabolic rate, glucose
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- George Mason UniversityUniversity, hospital or other
- Study start
- 29 May 2018 (actual)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 1 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capsaicin | Experimental | Dietary Supplement: Capsaicin4 tsp of cayenne pepper in a 60g omelette |
| Control | Placebo comparator | Dietary Supplement: Control60 g omelette |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 18-45 years of age females or 18-50 males
Key exclusion criteria (9 listed)
- BMI < 23 kg/m2 or >33 kg/m2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capsaicin4 tsp of cayenne in a breakfast omelette | Dietary supplement | Capsaicin |
| Controlbreakfast omelette without cayenne pepper | Dietary supplement | Control |
Primary outcome
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
1 secondary outcome
postprandial energy expenditure
Time frame: 3 hrs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.