Effect of 4-week Dihydrocapsiate Ingestion on Resting Metabolic Rate

Not Applicable

Completed

• Conditions: Obesity; Weight
• Interventions: Other: Dihydrocapsiate

• Registration Number: NCT00999297
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2008-07
• Study First Submitted: 2009-10-20
• Study First Submitted QC: 2009-10-20
• Study First Posted: 2009-10-21
• Primary Completion: 2009-11
• Study Completion: 2014-12
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-18
• Last Update Posted: 2015-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dihydrocapsiate	Dihydrocapsiate	Drug 3 mg/d or 9 mg/d including Placebo
3 mg/d or 9 mg/d Dihydrocapsiate	Dihydrocapsiate	Drug including Placebo
Sugar pill (Placebo o mg/d)	Dihydrocapsiate	0 mg/d sugar pill

Primary Outcome Measures

Name	Time	Method
The consumption of dihydrocapsiate will significantly increase resting energy expenditure and fat oxidation	4 weeks

Trial Locations

Locations (1)

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States