Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Capsimax Effect on Metabolic Rate, Satiety and Food Intake

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03489226
Recruitment Status : Completed
First Posted : April 5, 2018
Last Update Posted : August 31, 2018
Sponsor:
Collaborator:
OmniActive Health Technologies
Information provided by (Responsible Party):
Frank Greenway, Pennington Biomedical Research Center

Brief Summary:
Comparison of Capsimax™ 2mg and 4mg of capsicum extract vs. placebo on metabolic rate and satiety.

Condition or disease Intervention/treatment Phase
Energy Metabolism Eating Hunger Dietary Supplement: Capsimax Dietary Supplement: Placebo Other: Meal Not Applicable

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™.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 4 arm crossover trial
Masking: Double (Participant, Investigator)
Masking Description: Supplement and placebo capsules with identical appearance
Primary Purpose: Treatment
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.
Actual Study Start Date : May 2, 2016
Actual Primary Completion Date : July 12, 2017
Actual Study Completion Date : July 12, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Capsaicin

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.
Dietary Supplement: Capsimax
Capsimax

Placebo Comparator: Placebo
single dose with satiety measures and metabolic rate measured before and after. Food intake measured 1 hour after dose.
Dietary Supplement: Placebo
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.
Dietary Supplement: Capsimax
Capsimax

Other: Meal
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.
Dietary Supplement: Placebo
Placebo

Other: Meal
Meal




Primary Outcome Measures :
  1. Resting Metabolic Rate [ Time Frame: up to 5 hours ]
    Metabolic cart measurement difference before and after intervention


Secondary Outcome Measures :
  1. 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.

  2. Food Intake [ Time Frame: 1 hour after intervention ]
    Meal with unlimited portions



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03489226


Locations
Layout table for location information
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
OmniActive Health Technologies
Investigators
Layout table for investigator information
Principal Investigator: Frank L Greenway, MD Pennington Biomedical Research Center

Layout table for additonal information
Responsible Party: Frank Greenway, Medical Director and Professor, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT03489226     History of Changes
Other Study ID Numbers: PBRC 2016-011
First Posted: April 5, 2018    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Frank Greenway, Pennington Biomedical Research Center:
capsaicin
energy expenditure
satiety
food intake

Additional relevant MeSH terms:
Layout table for MeSH terms
Capsaicin
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs