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Completed

NCT Number: NCT02408289

The Randomized Controlled Cocoa-Appetite Trial

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Brooklyn College of the City University of New York

Brooklyn, New York, 11210, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lo-Flav

Dietary Supplement

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

Hi-Flav

Dietary Supplement

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.

Epicatechin

Dietary Supplement

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

Procyanidins

Dietary Supplement

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

Primary outcomes

  1. Appetite as assessed by amount of pizza eaten.

    Time frame: Two and a half hours

    Amount of pizza eaten to be assessed two and one half hours after ingestion of the beverage.

Secondary outcomes

  1. Appetite as assessed by a Visual Analog Scale

    Time frame: Two and one half hours

    Visual Analog Scale assessments to be conducted during the two and one half hours after ingestion of the beverage.

Sponsors and collaborators

Lead sponsor

Brooklyn College of the City University of New York

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 3, 2015
Registry last updated
Jan 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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