The Randomized Controlled Cocoa-Appetite Trial

Brooklyn College of the City University of New York

Status: Completed

Conditions: Obesity

Treatments: Dietary Supplement: Epicatechin; Dietary Supplement: Hi-Flav; Dietary Supplement: Procyanidins; Dietary Supplement: Lo-Flav

Study type: Interventional

Funder types: Other

Identifiers

NCT02408289

PSC-CUNY 66522-0044

Details and patient eligibility

About

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.

Full description

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

Enrollment: 28 patients

Sex: Male

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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28 participants in 4 patient groups, including a placebo group

Lo-Flav

Placebo Comparator group

Description:

Low-flavonoid cocoa powder with 0 mg of procyanidins and 0 mg epicatechin per kg of body weight will be consumed as a beverage

Treatment:

Dietary Supplement: Lo-Flav

Hi-Flav

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Hi-Flav

Epicatechin

Active Comparator group

Description:

Low-flavonoid cocoa powder plus 1 mg epicatechin per kg of body weight will be consumed as a beverage.

Treatment:

Dietary Supplement: Epicatechin

Procyanidins

Active Comparator group

Description:

Low-flavonoid cocoa powder plus 3.7 mg procyanidins per kg of body weight will be consumed as a beverage.

Treatment:

Dietary Supplement: Procyanidins