Capsimax Effect on Metabolic Rate, Satiety and Food Intake

Pennington Biomedical Research Center

Status: Completed

Conditions: Energy Metabolism; Hunger; Eating

Treatments: Dietary Supplement: Capsimax; Dietary Supplement: Placebo; Other: Meal

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03489226

PBRC 2016-011

Details and patient eligibility

About

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

Full 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™.

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 4 patient groups, including a placebo group

Capsimax 2 mg

Active Comparator group

Description:

single dose with satiety measures and metabolic rate measured before and after. Food intake measured 1 hour after dose.

Treatment:

Dietary Supplement: Capsimax

Placebo

Placebo Comparator group

Description:

single dose with satiety measures and metabolic rate measured before and after. Food intake measured 1 hour after dose.

Treatment:

Dietary Supplement: Placebo

Capsimax 4 mg plus 250 kcal meal

Active Comparator group

Description:

single dose with 250 kcal meal with satiety measures and metabolic rate measured before and after. Food intake measured 1 hour after dose.

Treatment:

Other: Meal

Dietary Supplement: Capsimax

Placebo plus 250 kcal meal

Placebo Comparator group

Description:

single dose with 250 kcal meal with satiety measures and metabolic rate measured before and after. Food intake measured 1 hour after dose.

Treatment:

Dietary Supplement: Placebo

Other: Meal