Effect of 4-week Dihydrocapsiate Ingestion on Resting Metabolic Rate

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obesity, Weight

Intervention / Treatment
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* Other: Dihydrocapsiate
* Other: Dihydrocapsiate
* Other: Dihydrocapsiate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Sugar pill (Placebo o mg/d)<br>0 mg/d sugar pill | Other: Dihydrocapsiate<br>* Capsules will contain dihydrocapsiate 3 mg/d or 9 mg/d or placebo<br>* Other names: Natural Substances present in chili pepper;|
| Active Comparator: Dihydrocapsiate<br>Drug 3 mg/d or 9 mg/d including Placebo | Other: Dihydrocapsiate<br>* Capsules will contain dihydrocapsiate 3 mg/d or 9 mg/d or placebo<br>* Other names: Natural Substances present in chili pepper;|
| Active Comparator: 3 mg/d or 9 mg/d Dihydrocapsiate<br>Drug including Placebo | Other: Dihydrocapsiate<br>* Capsules will contain dihydrocapsiate 3 mg/d or 9 mg/d or placebo<br>* Other names: Natural Substances present in chili pepper;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The consumption of dihydrocapsiate will significantly increase resting energy expenditure and fat oxidation |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thermogenesis, respiratory quotient, fat oxidation