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: December 7, 2012
Last verified: December 2012
  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 2013
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
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: December 7, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014