The Randomized Controlled Cocoa-Appetite Trial

January 12, 2016 updated by: James Greenberg, Brooklyn College of the City University of New York

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Brooklyn, New York, United States, 11210
        • Brooklyn College of the City University of New York

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 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
Dietary supplement: 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.
Active Comparator: 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.
Dietary supplement: Hi-Flav
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.
Active Comparator: Epicatechin
Low-flavonoid cocoa powder plus 1 mg epicatechin per kg of body weight will be consumed as a beverage.
Dietary supplement: Epicatechin
Low-flavonoid cocoa powder plus 1 mg epicatechin per kg of body weight will be consumed as a beverage
Active Comparator: Procyanidins
Low-flavonoid cocoa powder plus 3.7 mg procyanidins per kg of body weight will be consumed as a beverage.
Dietary supplement: Procyanidins
Low-flavonoid cocoa powder plus 3.7 mg procyanidins per kg of body weight will be consumed as a beverage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Two and a half hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Two and one half hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brooklyn College of the City University of New York

Investigators

  • Principal Investigator: James Greenberg, Ph.D, Department of Health & Nutritional Sciences, Brooklyn College of the City University of New York

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

April 2, 2015

First Submitted That Met QC Criteria

April 2, 2015

First Posted (Estimate)

April 3, 2015

Study Record Updates

Last Update Posted (Estimate)

January 13, 2016

Last Update Submitted That Met QC Criteria

January 12, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSC-CUNY 66522-0044

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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