Capsimax Effect on Metabolic Rate, Satiety and Food Intake

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™.

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.