Energy Metabolism, Eating, Hunger
Conditions
Keywords
capsaicin, energy expenditure, satiety, food intake
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™.
Sponsors
OmniActive Health Technologies
Pennington Biomedical Research Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Supplement and placebo capsules with identical appearance
Intervention model description
4 arm crossover trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Resting Metabolic Rate | up to 5 hours | Metabolic cart measurement difference before and after intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed