The Randomized Controlled Cocoa-Appetite Trial

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Dietary Supplement: Procyanidins; Dietary Supplement: Lo-Flav; Dietary Supplement: Epicatechin; Dietary Supplement: Hi-Flav

• Registration Number: NCT02408289
• Lead Sponsor: Brooklyn College of the City University of New York

Brief Summary

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

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

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-04-02
• Study First Submitted QC: 2015-04-02
• Study First Posted: 2015-04-03
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-12
• Last Update Posted: 2016-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Procyanidins	Procyanidins	Low-flavonoid cocoa powder plus 3.7 mg procyanidins per kg of body weight will be consumed as a beverage.
Lo-Flav	Lo-Flav	Low-flavonoid cocoa powder with 0 mg of procyanidins and 0 mg epicatechin per kg of body weight will be consumed as a beverage
Epicatechin	Epicatechin	Low-flavonoid cocoa powder plus 1 mg epicatechin per kg of body weight will be consumed as a beverage.
Hi-Flav	Hi-Flav	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.

Primary Outcome Measures

Name	Time	Method
Appetite as assessed by amount of pizza eaten.	Two and a half hours	Amount of pizza eaten to be assessed two and one half hours after ingestion of the beverage.

Secondary Outcome Measures

Name	Time	Method
Appetite as assessed by a Visual Analog Scale	Two and one half hours	Visual Analog Scale assessments to be conducted during the two and one half hours after ingestion of the beverage.

Trial Locations

Locations (1)

Brooklyn College of the City University of New York; 🇺🇸 Brooklyn, New York, United States