Capsimax Effect on Metabolic Rate, Satiety and Food Intake

• ClinicalTrials.gov Identifier: NCT03489226
• Recruitment Status: Completed
• First Posted: April 5, 2018
• Last Update Posted: August 31, 2018
• Sponsor: Pennington Biomedical Research Center
• Collaborator: OmniActive Health Technologies
• Information provided by (Responsible Party): Frank Greenway, Pennington Biomedical Research Center

Tracking Information

• First Submitted Date: December 18, 2017
• First Posted Date: April 5, 2018
• Last Update Posted Date: August 31, 2018
• Actual Study Start Date: May 2, 2016
• Actual Primary Completion Date: July 12, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 4, 2018)

Resting Metabolic Rate [ Time Frame: up to 5 hours ]

Metabolic cart measurement difference before and after intervention

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 28, 2018)

• Satiety by Visual Analog Scale (hunger, fullness, prospective food intake and satisfaction) [ Time Frame: 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 [ Time Frame: 1 hour after intervention ]
  Meal with unlimited portions

Original Secondary Outcome Measures (submitted: April 4, 2018)

• Satiety by Visual Analog Scale (hunger, fullness, prospective food intake and satisfaction) [ Time Frame: Baseline to 4 hours ]
  Difference in area under the curve from baseline of the Mean Visual Analog
• Food Intake [ Time Frame: 1 hour after intervention ]
  Meal with unlimited portions

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Capsimax Effect on Metabolic Rate, Satiety and Food Intake
• Official Title: 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.
• 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™.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

4 arm crossover trial

Masking: Double (Participant, Investigator)
Masking Description:

Supplement and placebo capsules with identical appearance

Primary Purpose: Treatment

Condition

• Energy Metabolism
• Eating
• Hunger

Intervention

• Dietary Supplement: Capsimax
  Capsimax
• Dietary Supplement: Placebo
  Placebo
• Other: Meal
  Meal

Study Arms

• Active Comparator: Capsimax 2 mg
  single dose with satiety measures and metabolic rate measured before and after. Food intake measured 1 hour after dose.
  Intervention: Dietary Supplement: Capsimax
• Placebo Comparator: Placebo
  single dose with satiety measures and metabolic rate measured before and after. Food intake measured 1 hour after dose.
  Intervention: Dietary Supplement: Placebo
• Active Comparator: Capsimax 4 mg plus 250 kcal meal
  single dose with 250 kcal meal with satiety measures and metabolic rate measured before and after. Food intake measured 1 hour after dose.
  Interventions:

  • Dietary Supplement: Capsimax
  • Other: Meal
• Placebo Comparator: Placebo plus 250 kcal meal
  single dose with 250 kcal meal with satiety measures and metabolic rate measured before and after. Food intake measured 1 hour after dose.
  Interventions:

  • Dietary Supplement: Placebo
  • Other: Meal

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 4, 2018): 24
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: July 12, 2017
• Actual Primary Completion Date: July 12, 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03489226
• Other Study ID Numbers: PBRC 2016-011
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Frank Greenway, Pennington Biomedical Research Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Pennington Biomedical Research Center
• Original Study Sponsor: Same as current
• Collaborators: OmniActive Health Technologies

Investigators

• Principal Investigator: Frank L Greenway, MD; Pennington Biomedical Research Center

• PRS Account: Pennington Biomedical Research Center
• Verification Date: August 2018