Capsimax Effect on Metabolic Rate, Satiety and Food Intake

Hunger Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03489226
• Other study ID #: PBRC 2016-011
• Status: Completed
• Phase: N/A
• Start date: May 2, 2016
• Est. completion date: July 12, 2017

Study information

• Verified date: August 2018
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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™.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 12, 2017
• Est. primary completion date: July 12, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Eating
• Energy Metabolism
• Hunger

Intervention

Dietary Supplement:
• Capsimax
Capsimax
• Placebo
Placebo

Other:
• Meal
Meal

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center	OmniActive Health Technologies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resting Metabolic Rate	Metabolic cart measurement difference before and after intervention	up to 5 hours
Secondary	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.	Baseline to 4 hours
Secondary	Food Intake	Meal with unlimited portions	1 hour after intervention