ObesityNCT02408289
The Randomized Controlled Cocoa-Appetite Trial
A study testing Lo-Flav, Hi-Flav and Epicatechin in people with Obesity, run by Brooklyn College of the City University of New York at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Lo-Flav, Hi-Flav and Epicatechin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brooklyn College of the City University of New York
Brooklyn, New York, 11210
About this study
Official title: 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.
Read the detailed description
The study is a four-way randomized double-blinded crossover trial with randomization balanced for beverage and lab visit order.
- Conditions
- Obesity
- Being tested
- Lo-Flav, Hi-Flav, Epicatechin, Procyanidins
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
EpicatechinDietary supplement
Low-flavonoid cocoa powder plus 1 mg epicatechin per kg of body weight will be consumed as a beverage
ProcyanidinsDietary supplement
Low-flavonoid cocoa powder plus 3.7 mg procyanidins per kg of body weight will be consumed as a beverage.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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. Receives: 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. Receives: Dietary Supplement: Procyanidins |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two and a half hours
Secondary outcomes (1)
Appetite as assessed by a Visual Analog Scale
Visual Analog Scale assessments to be conducted during the two and one half hours after ingestion of the beverage.
Measured: Two and one half hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brooklyn College of the City University of New York
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Greenberg, Brooklyn College of the City University of New York
- Investigators
- James Greenberg, Ph.D, Principal investigator, Department of Health & Nutritional Sciences, Brooklyn College of the City University of New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02408289
- Sponsor's protocol ID
- PSC-CUNY 66522-0044
- Status last verified
- Jan 2016
- First submitted
- 2 Apr 2015
- Last updated
- 13 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27510533
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Human Trial on The Effects of Cocoa on Appetite.
- ClinicalTrials.gov ID
- NCT02408289
- Acronym / sponsor ID
- PSC-CUNY 66522-0044
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Brooklyn College of the City University of New YorkUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 3 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
The study is a four-way randomized double-blinded crossover trial with randomization balanced for beverage and lab visit order.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lo-Flav | Placebo comparator | Dietary Supplement: Lo-FlavLow-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 | Active comparator | Dietary Supplement: Hi-FlavCocoa 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 | Active comparator | Dietary Supplement: EpicatechinLow-flavonoid cocoa powder plus 1 mg epicatechin per kg of body weight will be consumed as a beverage. |
| Procyanidins | Active comparator | Dietary Supplement: ProcyanidinsLow-flavonoid cocoa powder plus 3.7 mg procyanidins per kg of body weight will be consumed as a beverage. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lo-Flavlow-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-FlavHigh-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. | Dietary supplement | Hi-Flav |
| EpicatechinLow-flavonoid cocoa powder plus 1 mg epicatechin per kg of body weight will be consumed as a beverage | Dietary supplement | Epicatechin |
| ProcyanidinsLow-flavonoid cocoa powder plus 3.7 mg procyanidins per kg of body weight will be consumed as a beverage. | Dietary supplement | Procyanidins |
Primary outcome
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.
1 secondary outcome
Appetite as assessed by a Visual Analog Scale
Time frame: Two and one half hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2016.
- Derived from this study: PubMed 27510533Greenberg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Greenberg, Ph.D principal investigator
Department of Health & Nutritional Sciences, Brooklyn College of the City University of New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lo-Flav, Hi-Flav and Epicatechin in people with Obesity, run by Brooklyn College of the City University of New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appetite as assessed by amount of pizza eaten. (time frame: Two and a half hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02408289, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2016.