Dietary Flavanols and Dentate Gyrus Function



Status:Active, not recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:50 - 75
Updated:1/5/2019
Start Date:December 2015
End Date:May 2019

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Dietary Cocoa Flavanols and Age-Related Memory Decline

to assess the effect of differing amounts of a cocoa-derived dietary flavanol (epicatechin )
on dentate gyrus function and corresponding cognitive function

In this double blinded trial, the participants, age 50-75 years, will be randomized to
receive 0, 225, 400, or 650 mg daily for 12 weeks and will be tested before and after the
intervention. Cognitive testing will be conducted prior to randomization, and at weeks 4, 12,
and 20 of the study.

In an optional substudy, fMRI with gadolinium contrast will be conducted to measure dentate
gyrus function before randomization and then after completion of the 12-week intervention
portion of the trial.

Inclusion Criteria:

- 1. Signed and dated informed consent obtained before any trial-related activities.
(Trial-related activities are any procedure that would not have been performed during
normal management of the subject). Telephone Screen

2. Healthy Male or Female subjects. (Females must be post-menopausal) Telephone Screen

3. Age between 50 and 75 years, both inclusive. Telephone Screen

4. Body mass index between 18.0 and 35 kg/m², both inclusive. Telephone Screen

Exclusion Criteria:

1. Currently undergoing medical treatment, including prescription drugs/medication.
Medical History Interview

2. Clinically significant abnormal hematology, biochemistry, urinalysis, or coagulation
screening tests, as judged by the Investigator. Medical History Interview

3. History or presence of cancer (except basal cell skin cancer or squamous cell skin
cancer), or any clinically significant cardiovascular, respiratory, metabolic, renal,
hepatic, gastrointestinal, endocrinological (with the exception euthyroid struma),
haematological, dermatological, venereal, neurological, psychiatric diseases or other
major disorders as judged by the Investigator. Medical History Interview

4. Seated blood pressure at screening (after resting for 5 min in seated position)
outside the range of 90-140 mmHg for systolic or 50-90 mmHg for diastolic (excluding
white-coat hypertension; therefore, if a repeated measurement shows values within the
range, the subject can be included in the trial) and/or resting supine heart rate
outside the range 50-90 beats per minute. Measurement taken at consent before
eligibility is determined

5. Current Depression or Anxiety Symptoms using PHQ-8 and GAD-7. PHQ-8 score >= 10 and/or
GAD-7 score >= 10 are excluded. (Past history of disorders not exclusionary).
Interview

6. Currently taking SSRI medications for any reason. Interview

7. Heart Diseases. Medical History Interview

8. Hepatitis B or C positive status. Medical History Interview

9. HIV positive status. Medical History Interview

10. History of multiple and/or severe allergies to drugs or foods or a history of severe
anaphylactic reaction. Medical History Interview

11. Use of non-prescription medication, herbal products or nutritional supplements during
the study, and within the last 4 weeks before the start of the study (screening), as
judged by the Investigator; occasional use of aspirin, ibuprofen, acetaminophen is
permitted. Interview

12. Adherence to a vegan or vegetarian diet or to specialty/uncommon diets. Interview

13. Food Allergies to tree nuts, soy, cocoa and cocoa-containing products. Interview

14. People who choose to avoid caffeine intake. Interview

15. Current or history of alcoholism or drug/chemical abuse as per Investigator's
judgment. Medical History Interview

16. Hormone Replacement Therapy; Currently pregnant; Pregnant or lactating within past 6
mos; Hormonal birth control (pill). Interview

17. Smoking. Interview

18. Unwilling to have blood drawn or anxiety/nausea during a blood draw. Interview.

19. Uncomfortable completing memory and attention tasks in the English language. Interview

20. Montreal Cognitive Assessment (MoCA) score less than 26. Montreal Cognitive Assessment

21. Inability to swallow study capsules. Interview (at consent).

22. Did not complete the two weeks Run-In Period (Participants who missed more than 2
intake occasions out of 14 days (28 occasions total) or if there are > 8 capsules left
in the bottle after the two weeks will be excluded). Run-In Period.

MRI RELATED

1. Cardiac Pacemaker Interview

2. Internal Pump Interview

3. Insulin Pump Interview

4. Tattoo eyeliner Interview

5. Wire sutures Interview

6. Internal Metal Objects Interview

7. Metal Slivers in Eye Interview

8. Prosthesis Interview

9. Hearing Aid Implants Interview

10. Neurostimulator Interview

11. Metal Fragments Interview

12. Brain Aneurysm Clips Interview

13. Vascular Clips Interview

14. Breast Expander Interview

15. Vena Cava Filter Interview

16. Heart Valve Interview

17. Metal Stents Interview

18. Asthma Interview

19. Hay-Fever Interview

20. Sickle Cell Disease Interview

21. Kidney Disease Interview

22. Pregnant Interview

23. Claustrophobic Interview

24. Wheelchair bound Interview

25. Machinist or ever worked with heavy metals Interview

26. Contraindication to Gadolinium, including prior adverse reaction to gadolinium, past
or current history of severe breathing difficulty that has been treated by a physician
(e.g. asthma, COPD, etc) and sickle cell disease. History of renal impairment or
estimated glomerular filtration rate <30 L/min.1.732m2 is also exclusionary Interview;
Glomerular filtration rate assessed with creatinine via StatSensor monitor

27. Had more than one previous MRI scans with Gadolinium Interview
We found this trial at
1
site
630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Scott A Small, MD
Phone: 646-774-8952
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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mi
from
New York, NY
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