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Effect of 4-week Dihydrocapsiate Ingestion on Resting Metabolic Rate (CAPSPAL)

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ClinicalTrials.gov Identifier: NCT00999297
Recruitment Status : Completed
First Posted : October 21, 2009
Last Update Posted : November 20, 2015
Sponsor:
Collaborator:
Ajinomoto USA, INC.
Information provided by (Responsible Party):
Eric Ravussin, Pennington Biomedical Research Center

Brief Summary:
A 4 week intake of drug to find a natural substance that may modify energy balance and may enhance health in combination with lifestyle changes with possible decrease in body weight.

Condition or disease Intervention/treatment Phase
Obesity Weight Other: Dihydrocapsiate Not Applicable

Detailed Description:
This study is a double-blind, placebo-controlled, single center, randomized, parallel arm clinical trial to test the impact of Dihydrocapsiate (placebo, 3 and 9 mg/d) ingested for 4 weeks on resting metabolic rate and fat oxidation measured by indirect calorimetry.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Effect of 4-week Dihydrocapsiate Ingestion on Resting Metabolic Rate: A Double-blind Randomized Parallel Arm Study
Study Start Date : July 2008
Actual Primary Completion Date : November 2009
Actual Study Completion Date : December 2014

Arm Intervention/treatment
Placebo Comparator: Sugar pill (Placebo o mg/d)
0 mg/d sugar pill
Other: Dihydrocapsiate
Capsules will contain dihydrocapsiate 3 mg/d or 9 mg/d or placebo
Other Name: Natural Substances present in chili pepper

Active Comparator: Dihydrocapsiate
Drug 3 mg/d or 9 mg/d including Placebo
Other: Dihydrocapsiate
Capsules will contain dihydrocapsiate 3 mg/d or 9 mg/d or placebo
Other Name: Natural Substances present in chili pepper

Active Comparator: 3 mg/d or 9 mg/d Dihydrocapsiate
Drug including Placebo
Other: Dihydrocapsiate
Capsules will contain dihydrocapsiate 3 mg/d or 9 mg/d or placebo
Other Name: Natural Substances present in chili pepper




Primary Outcome Measures :
  1. The consumption of dihydrocapsiate will significantly increase resting energy expenditure and fat oxidation [ Time Frame: 4 weeks ]


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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men between 20-60 years old
  • Healthy as assessed by medical history and standard medical exam
  • Weight-stable
  • Body mass index of 25 to 34.9 kg/m2
  • Non-smoker
  • Sedentary lifestyle: not being physically active grater than 3 days/week for 20 min each time for the previous 6 months, and not participating in regular resistance exercise.

Exclusion Criteria:

  • Subjects enrolled in a diet to increase or decrease body weight
  • Special diet or food aversiions to common foods
  • Has allergy to chilli pepper
  • Eating chilli peppers on a daily basis
  • Usually consuming more than 2 cups of tea or coffee/day
  • Usually consuming more than 4 cans of caffeinated soft drinks a day
  • Usually consuming more than 3 standard alcohol drinks/day
  • Regular use of medications (weight loss drugs, drugs affecting energy metabolism, drugs for depression)
  • Usual intake of illicit substances
  • Claustrophobia
  • Participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00999297


Locations
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70809
Sponsors and Collaborators
Pennington Biomedical Research Center
Ajinomoto USA, INC.
Investigators
Principal Investigator: Eric Ravussin, PhD Pennington Biomedical Research Center

Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eric Ravussin, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT00999297     History of Changes
Other Study ID Numbers: PBRC 28016
PBRC28016 ( Other Identifier: Ajinomoto Co., Inc )
First Posted: October 21, 2009    Key Record Dates
Last Update Posted: November 20, 2015
Last Verified: November 2015

Keywords provided by Eric Ravussin, Pennington Biomedical Research Center:
thermogenesis
respiratory quotient
fat oxidation

Additional relevant MeSH terms:
Capsaicin
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs