Dietary Modulation of Neuroinflammation in Age-Related Memory Disorders

Within 25 years, the US population aged 65 and over will double in size to 80 million
bringing, with it an epidemic of aging-related cognitive decline, from normal cognitive aging
to neurodegenerative disorders including Alzheimer's Disease. These conditions impair quality
of life and functional status, impose an enormous burden on individuals, their families, the
healthcare system, and require elucidation of mechanisms and development of new treatments to
prevent or at least slow their progression. The use of plant-based food and drink for health
purposes has a long and well-documented history. Cocoa beans contain a substance that has
multiple beneficial health effects. In this study, the investigators will test the effect of
this substance on brain structures and cognitive outcomes in a 12-week randomized controlled
trial of 146 healthy participants, age 50-69, who will receive this cocoa derivative or a
placebo. The investigators also will examine the role of inflammation in this relationship.
Such a trial has potential for significant clinical impact.

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 screening or management of the subject).

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

3. Age between 50 and 69 years, both inclusive.

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

Exclusion Criteria:

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

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

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.

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. Heart Diseases.

6. Hepatitis B or C positive status.

7. HIV positive status.

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

9. 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.

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

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

12. People who choose to avoid caffeine intake.

13. Current or history of alcoholism or drug/chemical abuse as per Investigator's
judgment.

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

15. Smoking.

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

17. Uncomfortable completing memory and attention tasks in the English language

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

19. Inability to swallow study capsules Interview (at Consent)

20. 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).

MRI RELATED

1. Cardiac Pacemaker

2. Internal Pump

3. Insulin Pump

4. Tattoo eyeliner

5. Wire sutures

6. Internal Metal Objects

7. Metal Slivers in Eye

8. Prosthesis

9. Hearing Aid Implants

10. Neurostimulator

11. Metal Fragments

12. Brain Aneurysm Clips

13. Vascular Clips

14. Breast Expander

15. Vena Cava Filter

16. Heart Valve

17. Metal Stents

18. Asthmatic symptoms within the past 3 years

19. Sickle Cell Disease