Energy MetabolismNCT03489226
Capsimax Effect on Metabolic Rate, Satiety and Food Intake
A study testing Capsimax and Meal in people with Energy Metabolism and Eating, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
Comparison of Capsimax™ 2mg and 4mg of capsicum extract vs. placebo on metabolic rate and satiety. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Energy Metabolism, Eating, Hunger
- What is being tested?
- Capsimax and Meal
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2016to 12 Jul 2017
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI between 25 and 40 kg/m2 inclusive
- Healthy
- If of child-bearing potential, use of effective contraception
Who cannot join
- Subjects excluded will:
- Have received an investigational product in another trial within 30 days of enrollment.
- Have lost 10 or more pounds in the 3 months prior to randomization and maintained the weight loss.
- Use tobacco products
- Use a nicotine patch or gum.
- Take regular medication other than oral contraceptives or estrogen replacement therapy.
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- Take products containing ephedra or medications known to increase metabolic rate like stimulants taken for attention deficit disorder.
- Not eat at regular mealtimes.
- Have a history of alcohol or drug abuse in the past year.
- Nurse a baby or be a member of a vulnerable population including adults unable to consent, pregnant women, prisoners or minors.
- Have a clinically significant history of diabetes, high blood pressure (>140/90), thyroid disease, heart disease, kidney disease or liver disease.
- Have a known allergy to capsaicin caffeine, piperine or niacin.
- Have clinically significant laboratory findings in the opinion of the investigator.
- Score greater than 13 on the restraint scale of the 3-factor eating questionnaire.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: A Pilot Study of the Effect of a Dietary Herbal Supplement Containing Capsaicin or Placebo on Satiety, Metabolic Rate and Food Intake in Healthy Adults.
Comparison of Capsimax™ 2mg and 4mg of capsicum extract vs. placebo on metabolic rate and satiety.
Read the detailed description
Capsimax™ is a capsicum extract in a bead technology to avoid oral and gastric burning. Capsimax™ 2mg, Capsimax™ 4 mg and placebo was initially given as a single dose on an empty stomach with measures of metabolic rate, and satiety before and after and food intake at 1 hour after Capsimax™.
- Conditions
- Energy Metabolism, Eating, Hunger
- Being tested
- Capsimax, Placebo, Meal
- Keywords
- capsaicin, energy expenditure, satiety, food intake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapsimaxDietary supplement
Capsimax
PlaceboDietary supplement
Placebo
MealOther
Meal
| Study group | Role | What they receive |
|---|---|---|
| Capsimax 2 mg | Active comparator | single dose with satiety measures and metabolic rate measured before and after. Food intake measured 1 hour after dose. Receives: Dietary Supplement: Capsimax |
| Placebo | Placebo comparator | single dose with satiety measures and metabolic rate measured before and after. Food intake measured 1 hour after dose. Receives: Dietary Supplement: Placebo |
| Capsimax 4 mg plus 250 kcal meal | Active comparator | single dose with 250 kcal meal with satiety measures and metabolic rate measured before and after. Food intake measured 1 hour after dose. Receives: Dietary Supplement: Capsimax; Other: Meal |
| Placebo plus 250 kcal meal | Placebo comparator | single dose with 250 kcal meal with satiety measures and metabolic rate measured before and after. Food intake measured 1 hour after dose. Receives: Dietary Supplement: Placebo; Other: Meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting Metabolic Rate
Metabolic cart measurement difference before and after intervention
Measured: up to 5 hours
Secondary outcomes (2)
Satiety by Visual Analog Scale (hunger, fullness, prospective food intake and satisfaction)
Difference in area under the curve from baseline of the Mean Visual Analog. Each question on the scale ranges from 0 to 100 mm. The two ends of the scale are anchored by the highest and lowest values (e.g. "the hungriest I have ever been" to "no hunger at all"). Some questions have high values on the right and others have high values on the left. Each question (hunger, fullness, prospective food intake and satisfaction) is a sub-scale. Each sub-scale is scored separately.
Measured: Baseline to 4 hours
Food Intake
Meal with unlimited portions
Measured: 1 hour after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start2 May 2016
- Primary completion12 Jul 2017
- Study completion12 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Energy MetabolismStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 4 arm crossover trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- OmniActive Health Technologies
- Responsible party
- Principal investigator, Frank Greenway, Pennington Biomedical Research Center
- Investigators
- Frank L Greenway, MD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03489226
- Sponsor's protocol ID
- PBRC 2016-011
- Status last verified
- Aug 2018
- First submitted
- 18 Dec 2017
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Effect of a Dietary Herbal Supplement Containing Capsaicin or Placebo on Satiety, Metabolic Rate and Food Intake in Healthy Adults.
- ClinicalTrials.gov ID
- NCT03489226
- Acronym / sponsor ID
- PBRC 2016-011
- Conditions
- Energy Metabolism, Eating, Hunger
- Keywords
- capsaicin, energy expenditure, satiety, food intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- OmniActive Health Technologies
- Study start
- 2 May 2016 (actual)
- Primary completion
- 12 Jul 2017 (actual)
- Study completion
- 12 Jul 2017 (actual)
- First posted
- 5 Apr 2018 (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.
Comparison of Capsimax™ 2mg and 4mg of capsicum extract vs. placebo on metabolic rate and satiety.
Detailed description
Capsimax™ is a capsicum extract in a bead technology to avoid oral and gastric burning. Capsimax™ 2mg, Capsimax™ 4 mg and placebo was initially given as a single dose on an empty stomach with measures of metabolic rate, and satiety before and after and food intake at 1 hour after Capsimax™.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- 4 arm crossover trial
| Arm | Type | Receives |
|---|---|---|
| Capsimax 2 mg | Active comparator | Dietary Supplement: Capsimaxsingle dose with satiety measures and metabolic rate measured before and after. Food intake measured 1 hour after dose. |
| Placebo | Placebo comparator | Dietary Supplement: Placebosingle dose with satiety measures and metabolic rate measured before and after. Food intake measured 1 hour after dose. |
| Capsimax 4 mg plus 250 kcal meal | Active comparator | Dietary Supplement: Capsimax, Other: Mealsingle dose with 250 kcal meal with satiety measures and metabolic rate measured before and after. Food intake measured 1 hour after dose. |
| Placebo plus 250 kcal meal | Placebo comparator | Dietary Supplement: Placebo, Other: Mealsingle dose with 250 kcal meal with satiety measures and metabolic rate measured before and after. Food intake measured 1 hour after dose. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI between 25 and 40 kg/m2 inclusive
- Healthy
- If of child-bearing potential, use of effective contraception
Key exclusion criteria (14 listed)
- Have received an investigational product in another trial within 30 days of enrollment.
- Have lost 10 or more pounds in the 3 months prior to randomization and maintained the weight loss.
- Use tobacco products
- Use a nicotine patch or gum.
- Take regular medication other than oral contraceptives or estrogen replacement therapy.
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 |
|---|---|---|
| CapsimaxCapsimax | Dietary supplement | Capsimax 2 mg, Capsimax 4 mg plus 250 kcal meal |
| PlaceboPlacebo | Dietary supplement | Placebo, Placebo plus 250 kcal meal |
| MealMeal | Other | Capsimax 4 mg plus 250 kcal meal, Placebo plus 250 kcal meal |
Primary outcome
Resting Metabolic Rate
Time frame: up to 5 hours
Metabolic cart measurement difference before and after intervention
2 secondary outcomes
Satiety by Visual Analog Scale (hunger, fullness, prospective food intake and satisfaction)
Time frame: Baseline to 4 hours
Food Intake
Time frame: 1 hour after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
- Individual participant dataSharing planned: No
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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.
Frank L Greenway, MD principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capsimax and Meal in people with Energy Metabolism and Eating, run by Pennington Biomedical Research Center 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 3 inclusion and 14 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: finished, as of the sponsor's last update on 31 Aug 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting Metabolic Rate (time frame: up to 5 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 31 Aug 2018.