The Randomized Controlled Cocoa-Appetite Trial

NCT ID: NCT02408289

Last Updated: 2016-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-05-31

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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Group Type PLACEBO_COMPARATOR

Lo-Flav

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

Hi-Flav

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Epicatechin

Intervention Type DIETARY_SUPPLEMENT

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

Procyanidins

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

Group Type ACTIVE_COMPARATOR

Procyanidins

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Epicatechin

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

Intervention Type DIETARY_SUPPLEMENT

Procyanidins

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

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Brooklyn College of the City University of New York

OTHER

Sponsor Role lead

Responsible Party

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James Greenberg

Associate Professor, Department of Health & Nutrition Sciences,

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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James Greenberg, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Department of Health & Nutritional Sciences, Brooklyn College of the City University of New York

Locations

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Brooklyn College of the City University of New York

Brooklyn, New York, United States

Site Status

Countries

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United States

References

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Greenberg JA, O'Donnell R, Shurpin M, Kordunova D. Epicatechin, procyanidins, cocoa, and appetite: a randomized controlled trial. Am J Clin Nutr. 2016 Sep;104(3):613-9. doi: 10.3945/ajcn.115.129783. Epub 2016 Aug 10.

Reference Type DERIVED
PMID: 27510533 (View on PubMed)

Other Identifiers

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PSC-CUNY 66522-0044

Identifier Type: -

Identifier Source: org_study_id

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