Statistical Analysis Center
Dietary Modulation of Neuroinflammation
in Age-Related Memory Disorders
Statistics | Data Management | Coordination
                                                                               
                       


Welcome to the Cocoa Flavanols and Memory Study. This study examines the effect of dietary flavanols on brain activity. Flavanols are a specific group of plant-based nutrients found in cocoa beans, grapes, tea, berries and other fruits and vegetables. The specific flavanols examined in this study are from cocoa.

This brief summary provides some basic study information.

During an online Consent Appointment, you will be asked to read and sign the informed consent form then will complete some forms and evaluations to determine initial eligibility.

If you are eligible, you will be asked to take three capsules containing cocoa flavanols once a day with a meal for 12 weeks.

Before and after this 12-week period, you will complete the following assessments:
  1. Neuropsychological Testing Sessions: a series of computer based and paper/pencil tests to assess memory and attention.
  2. Blood Draw: You will be asked to have fasting blood draws.
  3. MRls: Scans of your brain using a contrast agent called Gadolinium.
Some of these assessments are completed online but some require a visit to the medical center.

This study includes some risks and discomforts: risk of infection with COVID-19 related to travel to the medical center, discomfort from blood draw, cocoa flavanol intake problems, MRI contraindications including a Gadolinium contrast agent administered to you intravenously (i.e., through the vein). The FDA has announced that they are investigating a possible risk of adverse health effects from repeated use of gadolinium for MRI. Although the FDA has not reached a conclusion, you may not participate in this study if you have previously had more than one MRI scan with gadolinium.

This study is voluntary and you do not have to participate if you do not want to. You may stop participating at any time.

To determine whether you are eligible to participate, please complete this brief survey. It will only take 5-10 minutes. Please make sure that you are in a private location. All questions are required. You may stop the survey at any time by closing the tab on your browser. If you do not complete the survey, no information will be saved.

To begin, click the arrow on the right, below. Click on the arrows at the bottom of the screen to move through the survey.

If you are initially eligible, a study research assistant will contact you with more information regarding your participation.

The information you provide is confidential, stored on computers certified as secure by Columbia University Medical Center, and available only to authorized study personnel.

If you have any questions, please contact the study coordinator at psychiatry.bmed@cumc.columbia.edu or (646) 774-8952.

Thank you for your interest!


Department of Biostatistics

Statistical Analysis Center
722 W 168 Street | Rm 610 | New York, NY 10032
sac-biostat@columbia.edu | 212.342.2000
Mailman School of Public Health