NCT02408289

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Mar 2015

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 2, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 3, 2015

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

January 13, 2016

Status Verified

January 1, 2016

Enrollment Period

2 months

First QC Date

April 2, 2015

Last Update Submit

January 12, 2016

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Appetite as assessed by amount of pizza eaten.

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

    Two and a half hours

Secondary Outcomes (1)

  • Appetite as assessed by a Visual Analog Scale

    Two and one half hours

Study Arms (4)

Lo-Flav

PLACEBO COMPARATOR

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

Hi-Flav

ACTIVE COMPARATOR

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

Epicatechin

ACTIVE COMPARATOR

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

Dietary Supplement: Epicatechin

Procyanidins

ACTIVE COMPARATOR

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

Dietary Supplement: Procyanidins

Interventions

Lo-FlavDIETARY_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.

Lo-Flav
Hi-FlavDIETARY_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.

Hi-Flav
EpicatechinDIETARY_SUPPLEMENT

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

Epicatechin
ProcyanidinsDIETARY_SUPPLEMENT

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

Procyanidins

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brooklyn College of the City University of New York

Brooklyn, New York, 11210, United States

Location

Related Publications (1)

  • 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.

    PMID: 27510533DERIVED

MeSH Terms

Conditions

Obesity

Interventions

CatechinProanthocyanidins

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChromansBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFlavonoidsChromonesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingTanninsBiopolymersPolymersMacromolecular Substances

Study Officials

  • James Greenberg, Ph.D

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Department of Health & Nutrition Sciences,

Study Record Dates

First Submitted

April 2, 2015

First Posted

April 3, 2015

Study Start

March 1, 2015

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

January 13, 2016

Record last verified: 2016-01

Locations

US(1)