- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03489226
Capsimax Effect on Metabolic Rate, Satiety and Food Intake
August 28, 2018 updated by: Frank Greenway, Pennington Biomedical Research Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Louisiana
-
Baton Rouge, Louisiana, United States, 70808
- Pennington Biomedical Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- BMI between 25 and 40 kg/m2 inclusive
- Healthy
- If of child-bearing potential, use of effective contraception
Exclusion Criteria:
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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Capsimax 2 mg
single dose with satiety measures and metabolic rate measured before and after.
Food intake measured 1 hour after dose.
|
Capsimax
|
Placebo Comparator: Placebo
single dose with satiety measures and metabolic rate measured before and after.
Food intake measured 1 hour after dose.
|
Placebo
|
Active Comparator: Capsimax 4 mg plus 250 kcal meal
single dose with 250 kcal meal with satiety measures and metabolic rate measured before and after.
Food intake measured 1 hour after dose.
|
Capsimax
Meal
|
Placebo Comparator: Placebo plus 250 kcal meal
single dose with 250 kcal meal with satiety measures and metabolic rate measured before and after.
Food intake measured 1 hour after dose.
|
Placebo
Meal
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Resting Metabolic Rate
Time Frame: up to 5 hours
|
Metabolic cart measurement difference before and after intervention
|
up to 5 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Satiety by Visual Analog Scale (hunger, fullness, prospective food intake and satisfaction)
Time Frame: Baseline to 4 hours
|
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.
|
Baseline to 4 hours
|
Food Intake
Time Frame: 1 hour after intervention
|
Meal with unlimited portions
|
1 hour after intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 2, 2016
Primary Completion (Actual)
July 12, 2017
Study Completion (Actual)
July 12, 2017
Study Registration Dates
First Submitted
December 18, 2017
First Submitted That Met QC Criteria
April 4, 2018
First Posted (Actual)
April 5, 2018
Study Record Updates
Last Update Posted (Actual)
August 31, 2018
Last Update Submitted That Met QC Criteria
August 28, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PBRC 2016-011
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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