Effect of Dihydrocapsiate on Energy Expenditure in Women

Study Overview
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Brief Summary
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The objective of this study is to test the effect of dihydrocapsiate on energy expenditure in women.

Detailed Description
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Capsaicin, a substance found in chili pepper, is known to stimulate thermogenesis. Dihydrocapsiate, a capsinoid, found in the non-pungent CH-19 sweet pepper has similar thermogenic effects without the gastrointestinal side effects. The objective of this project is to test the effect of 12 weeks of daily consumption of 9 mg dihydrocapsiate on resting energy expenditure relative to baseline when compared to a control group consuming products without DCT.

Official Title
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Randomized, Controlled, Parallel Trial to Evaluate the Effects of Dihydrocapsiate on Energy Expenditure in Women

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: Dihydrocapsiate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI: 18.5-34.5 kg/m2 Good general health Low to mild physical activity Willing to maintain habitual diet and physical activity patterns throughout the study period Premenopausal and cycling regularly or using oral contraceptives Willing to attend study visits only during the follicular phase or bleed phase of their menstrual cycle Understands study procedures and signs forms providing informed consent to participate in the study Have spoken and written English literacy Exclusion Criteria: Diabetes mellitus or any conditions that might affect energy metabolism Weight change ±2 kg over previous three months Known sensitivity or allergy to ingredients of the study products Non-breakfast eater Recent use of antibiotics History of smoking during the six months prior to study Recent signs or symptoms of infection, including cold or flu-like symptoms Concurrent or recent intervention study participation Instability in breathing patterns or energy expenditure measures History of drug or alcohol abuse Lipid-lowering, anti-hypertensive or anti-inflammatory steroid medication use Weight loss medication Pregnant or lactating Unwilling to be randomized to any experimental group and unable to meet all requirements of the study

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

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: Placebo 0 mg/d<br>0 mg/d of Dihydrocapsiate will be consumed in ready to ear cereal, cereal bars or crackers | Dietary Supplement: Dihydrocapsiate<br>* Kellogg's ready to eat cereal, cereal bars, and crackers will contain dihyrocapsiate or placebo. Daily consumption of dihydrocapsiate is 9mg/d or 0mg/d.<br>* Other names: Natural substances present in sweet chili peppers;|
| Active Comparator: Dihydrocapsiate 9 mg/d<br>9 mg/d of Dihydrocapsiate will be consumed in ready to ear cereal, cereal bars or crackers | Dietary Supplement: Dihydrocapsiate<br>* Kellogg's ready to eat cereal, cereal bars, and crackers will contain dihyrocapsiate or placebo. Daily consumption of dihydrocapsiate is 9mg/d or 0mg/d.<br>* Other names: Natural substances present in sweet chili peppers;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resting Energy Expenditure |  | Change from Baseline at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thermic effect of feeding |  | Change from baseline at 12 weeks | 
| Body Composition |  | Change from baseline at 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Body Weight, Body Composition, Metabolism, Resting Energy Expenditure