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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Ajinomoto USA, INC.
Information provided by (Responsible Party):
Eric Ravussin, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT00999297
First received: October 20, 2009
Last updated: August 8, 2014
Last verified: August 2014
  Purpose

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 Intervention
Obesity
Weight Control
Other: Dihydrocapsiate

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Effect of 4-week Dihydrocapsiate Ingestion on Resting Metabolic Rate: A Double-blind Randomized Parallel Arm Study

Resource links provided by NLM:


Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • The consumption of dihydrocapsiate will significantly increase resting energy expenditure and fat oxidation [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 86
Study Start Date: July 2008
Estimated Study Completion Date: December 2014
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Pennington Biomedical Research Center

Additional 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: CAPSPAL PBRC28016, PBRC28016
Study First Received: October 20, 2009
Last Updated: August 8, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 30, 2014