Capsimax Effect on Metabolic Rate, Satiety and Food Intake

Not Applicable

Completed

• Conditions: Energy Metabolism; Eating; Hunger
• Interventions: Dietary Supplement: Capsimax; Dietary Supplement: Placebo; Other: Meal

• Registration Number: NCT03489226
• Lead Sponsor: Pennington Biomedical Research Center

Brief Summary

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

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 Timeline

• Study Start: 2016-05-02
• Primary Completion: 2017-07-12
• Study Completion: 2017-07-12
• Study First Submitted: 2017-12-18
• Study First Submitted QC: 2018-04-04
• Study First Posted: 2018-04-05
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-28
• Last Update Posted: 2018-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Capsimax 2 mg	Capsimax	single dose with satiety measures and metabolic rate measured before and after. Food intake measured 1 hour after dose.
Placebo	Placebo	single dose with satiety measures and metabolic rate measured before and after. Food intake measured 1 hour after dose.
Capsimax 4 mg plus 250 kcal meal	Capsimax	single dose with 250 kcal meal with satiety measures and metabolic rate measured before and after. Food intake measured 1 hour after dose.
Capsimax 4 mg plus 250 kcal meal	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 plus 250 kcal meal	Placebo	single dose with 250 kcal meal with satiety measures and metabolic rate measured before and after. Food intake measured 1 hour after dose.
Placebo plus 250 kcal meal	Meal	single dose with 250 kcal meal with satiety measures and metabolic rate measured before and after. Food intake measured 1 hour after dose.

Primary Outcome Measures

Name	Time	Method
Resting Metabolic Rate	up to 5 hours	Metabolic cart measurement difference before and after intervention

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States