Effect of 4-week Dihydrocapsiate Ingestion on Resting Metabolic Rate

Obesity Clinical Trial

— CAPSPAL  

Official title:

Effect of 4-week Dihydrocapsiate Ingestion on Resting Metabolic Rate: A Double-blind Randomized Parallel Arm Study

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

• Obesity
• Weight

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

External Links

•   Effect of capsinoids on energy metabolism in human subjects
•   Effect of dihydrocapsiate on resting metabolic rate in humans.