Capsimax Effect on Metabolic Rate, Satiety and Food Intake

NCT03489226 | Completed

• 1 other identifier: PBRC 2016-011
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Energy Metabolism; Eating; Hunger

Keywords

capsaicin; energy expenditure; satiety; food intake

Outcome Measures

Primary Outcomes (1)

• Resting Metabolic Rate

  Metabolic cart measurement difference before and after intervention

  up to 5 hours

Secondary Outcomes (2)

• Satiety by Visual Analog Scale (hunger, fullness, prospective food intake and satisfaction)

  Baseline to 4 hours

• Food Intake

  1 hour after intervention

Study Arms (4)

Capsimax 2 mg

ACTIVE COMPARATOR

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

Dietary Supplement: Capsimax

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Capsimax 4 mg plus 250 kcal meal

ACTIVE COMPARATOR

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; Other: Meal

Placebo plus 250 kcal meal

PLACEBO COMPARATOR

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; Other: Meal

Interventions

Capsimax DIETARY_SUPPLEMENT

Capsimax

Capsimax 2 mg; Capsimax 4 mg plus 250 kcal meal

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo; Placebo plus 250 kcal meal

Meal OTHER

Meal

Capsimax 4 mg plus 250 kcal meal; Placebo plus 250 kcal meal

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI between 25 and 40 kg/m2 inclusive
• Healthy
• If of child-bearing potential, use of effective contraception

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• OmniActive Health Technologies: collaborator

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Interventions

Meals

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Frank L Greenway, MD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Supplement and placebo capsules with identical appearance
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director and Professor

Model Details: 4 arm crossover trial

Study Record Dates

• First Submitted: December 18, 2017
• First Posted: April 5, 2018
• Study Start: May 2, 2016
• Primary Completion: July 12, 2017
• Study Completion: July 12, 2017
• Last Updated: August 31, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)