The Randomized Controlled Cocoa-Appetite Trial

Study Overview
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Brief Summary
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The purpose of this study is to determine whether high-flavonoid cocoa can decrease appetite in humans. In addition the study is designed to test epicatechin, a compound found in cocoa and procyanidins, a class of compounds found in cocoa, for their ability to decrease appetite in humans.

Detailed Description
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The study is a four-way randomized double-blinded crossover trial with randomization balanced for beverage and lab visit order.

Official Title
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A Pilot Randomized Human Trial on The Effects of Cocoa on Appetite.

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: Lo-Flav
* Dietary Supplement: Hi-Flav
* Dietary Supplement: Epicatechin
* Dietary Supplement: Procyanidins


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: stable-weight, as indicated by weight gain or loss of <2% in the past 6 months; engaging in only mild exercise< twice a week; moderate alcohol users, <2 drinks/day; willing to eat pizza. mentally and physically healthy. Exclusion Criteria: smokers regular; frequent drinkers of coffee, tea or cola sodas, >daily; underweight or obese (BMI: <18.5 or >30 Kg/m2); allergies to chocolate, cocoa, green tea, coffee or pizza; using medication; interested in registering in the future for the course Health & Nutrition Sciences 2140, Introduction to the U.S. Health Care System, that is often taught by the PI of the proposed study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Male

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Lo-Flav<br>Low-flavonoid cocoa powder with 0 mg of procyanidins and 0 mg epicatechin per kg of body weight will be consumed as a beverage | Dietary Supplement: Lo-Flav<br>* low-flavonoid cocoa powder with 0 mg of procyanidins and 0 mg epicatechin per kg of body weight will be consumed as a beverage.<br>|
| Active Comparator: Hi-Flav<br>Cocoa powder with 3.8 mg procyanidins per kg of body weight and 0.6 mg Epicatechin per kg of body weight will be consumed as a beverage. | Dietary Supplement: Hi-Flav<br>* High-flavonoid cocoa powder with 3.8 mg procyanidins per kg of body weight and 0.6 mg Epicatechin per kg of body weight will be consumed as a beverage.<br>|
| Active Comparator: Epicatechin<br>Low-flavonoid cocoa powder plus 1 mg epicatechin per kg of body weight will be consumed as a beverage. | Dietary Supplement: Epicatechin<br>* Low-flavonoid cocoa powder plus 1 mg epicatechin per kg of body weight will be consumed as a beverage<br>|
| Active Comparator: Procyanidins<br>Low-flavonoid cocoa powder plus 3.7 mg procyanidins per kg of body weight will be consumed as a beverage. | Dietary Supplement: Procyanidins<br>* Low-flavonoid cocoa powder plus 3.7 mg procyanidins per kg of body weight will be consumed as a beverage.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appetite as assessed by amount of pizza eaten. | Amount of pizza eaten to be assessed two and one half hours after ingestion of the beverage. | Two and a half hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appetite as assessed by a Visual Analog Scale | Visual Analog Scale assessments to be conducted during the two and one half hours after ingestion of the beverage. | Two and one half hours |