Capsimax Effect on Metabolic Rate, Satiety and Food Intake

• ClinicalTrials.gov Identifier: NCT03489226
• Recruitment Status: Completed
• First Posted: April 5, 2018
• Last Update Posted: August 31, 2018
• Sponsor: Pennington Biomedical Research Center
• Collaborator: OmniActive Health Technologies
• Information provided by (Responsible Party): Frank Greenway, Pennington Biomedical Research Center

Study Description

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™.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Locations

United States, Louisiana

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States, 70808

Sponsors and Collaborators

Pennington Biomedical Research Center

OmniActive Health Technologies

Investigators

• Principal Investigator: Frank L Greenway, MD; Pennington Biomedical Research Center

More Information

• Responsible Party: Frank Greenway, Medical Director and Professor, Pennington Biomedical Research Center
• ClinicalTrials.gov Identifier: NCT03489226
• Other Study ID Numbers: PBRC 2016-011
• First Posted: April 5, 2018
• Last Update Posted: August 31, 2018
• Last Verified: August 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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