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Trial record 46 of 84 for:    catechin

The Randomized Controlled Cocoa-Appetite Trial

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ClinicalTrials.gov Identifier: NCT02408289
Recruitment Status : Completed
First Posted : April 3, 2015
Last Update Posted : January 13, 2016
Sponsor:
Information provided by (Responsible Party):
James Greenberg, 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.

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Lo-Flav Dietary Supplement: Hi-Flav Dietary Supplement: Epicatechin Dietary Supplement: Procyanidins Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Pilot Randomized Human Trial on The Effects of Cocoa on Appetite.
Study Start Date : March 2015
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02408289


Locations
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United States, New York
Brooklyn College of the City University of New York
Brooklyn, New York, United States, 11210
Sponsors and Collaborators
Brooklyn College of the City University of New York
Investigators
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Principal Investigator: James Greenberg, Ph.D Department of Health & Nutritional Sciences, Brooklyn College of the City University of New York

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: James Greenberg, Associate Professor, Department of Health & Nutrition Sciences,, Brooklyn College of the City University of New York
ClinicalTrials.gov Identifier: NCT02408289     History of Changes
Other Study ID Numbers: PSC-CUNY 66522-0044
First Posted: April 3, 2015    Key Record Dates
Last Update Posted: January 13, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
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Procyanidin
Proanthocyanidin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents