Capsimax Effect on Metabolic Rate, Satiety and Food Intake

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

Detailed Description
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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™.

Official Title
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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.

Conditions
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Energy Metabolism, Eating, Hunger

Intervention / Treatment
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* Dietary Supplement: Capsimax
* Dietary Supplement: Placebo
* Other: Meal


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 4 arm crossover trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Capsimax 2 mg<br>single dose with satiety measures and metabolic rate measured before and after. Food intake measured 1 hour after dose. | Dietary Supplement: Capsimax<br>* Capsimax<br>|
| Placebo Comparator: Placebo<br>single dose with satiety measures and metabolic rate measured before and after. Food intake measured 1 hour after dose. | Dietary Supplement: Placebo<br>* Placebo<br>|
| Active Comparator: Capsimax 4 mg plus 250 kcal meal<br>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<br>* Capsimax<br>Other: Meal<br>* Meal<br>|
| Placebo Comparator: Placebo plus 250 kcal meal<br>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<br>* Placebo<br>Other: Meal<br>* Meal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resting Metabolic Rate | Metabolic cart measurement difference before and after intervention | up to 5 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Food Intake | Meal with unlimited portions | 1 hour after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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capsaicin, energy expenditure, satiety, food intake