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

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:

  1. BMI between 25 and 40 kg/m2 inclusive
  2. Healthy
  3. If of child-bearing potential, use of effective contraception

Exclusion Criteria:

Subjects excluded will:

  1. Have received an investigational product in another trial within 30 days of enrollment.
  2. Have lost 10 or more pounds in the 3 months prior to randomization and maintained the weight loss.
  3. Use tobacco products
  4. Use a nicotine patch or gum.
  5. Take regular medication other than oral contraceptives or estrogen replacement therapy.
  6. Take products containing ephedra or medications known to increase metabolic rate like stimulants taken for attention deficit disorder.
  7. Not eat at regular mealtimes.
  8. Have a history of alcohol or drug abuse in the past year.
  9. Nurse a baby or be a member of a vulnerable population including adults unable to consent, pregnant women, prisoners or minors.
  10. Have a clinically significant history of diabetes, high blood pressure (>140/90), thyroid disease, heart disease, kidney disease or liver disease.
  11. Have a known allergy to capsaicin caffeine, piperine or niacin.
  12. Have clinically significant laboratory findings in the opinion of the investigator.
  13. 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.

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

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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