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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00999297
Other study ID # PBRC 28016
Secondary ID PBRC28016
Status Completed
Phase N/A
First received October 20, 2009
Last updated November 18, 2015
Start date July 2008
Est. completion date December 2014

Study information

Verified date November 2015
Source Pennington Biomedical Research Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 79
Est. completion date December 2014
Est. primary completion date November 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 60 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Other:
Dihydrocapsiate
Capsules will contain dihydrocapsiate 3 mg/d or 9 mg/d or placebo
Dihydrocapsiate
Capsules will contain dihydrocapsiate 3 mg/d or 9 mg/d or placebo
Dihydrocapsiate
Capsules will contain dihydrocapsiate 3 mg/d or 9 mg/d or placebo

Locations

Country Name City State
United States Pennington Biomedical Research Center Baton Rouge Louisiana

Sponsors (2)

Lead Sponsor Collaborator
Pennington Biomedical Research Center Ajinomoto USA, INC.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Galgani JE, Ryan DH, Ravussin E. Effect of capsinoids on energy metabolism in human subjects. Br J Nutr. 2010 Jan;103(1):38-42. doi: 10.1017/S0007114509991358. Epub 2009 Aug 12. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The consumption of dihydrocapsiate will significantly increase resting energy expenditure and fat oxidation 4 weeks No
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