Capsimax Effect on Metabolic Rate, Satiety and Food Intake

Sponsor

Pennington Biomedical Research Center (Other)

Overall Status

Completed

CT.gov ID

NCT03489226

Collaborator

OmniActive Health Technologies (Industry)

Enrollment

Location

Arms

14.3

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

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	N/A

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

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

4 arm crossover trial4 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 :

Jul 12, 2017

Actual Study Completion Date :

Jul 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

Resting Metabolic Rate [up to 5 hours]
Metabolic cart measurement difference before and after intervention

Secondary Outcome Measures

Satiety by Visual Analog Scale (hunger, fullness, prospective food intake and satisfaction) [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.
Food Intake [1 hour after intervention]
Meal with unlimited portions

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Apr 5, 2018

Last Update Posted:

Aug 31, 2018

Last Verified:

Aug 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Frank Greenway, Medical Director and Professor, Pennington Biomedical Research Center

Study Results

No Results Posted as of Aug 31, 2018