Dietary Flavanols and Dentate Gyrus Function
Memory Loss
About this trial
This is an interventional basic science trial for Memory Loss
Eligibility Criteria
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:
- Currently undergoing medical treatment, including prescription drugs/medication. Medical History Interview
- Clinically significant abnormal hematology, biochemistry, urinalysis, or coagulation screening tests, as judged by the Investigator. Medical History Interview
- 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
- 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
Current Depression or Anxiety Symptoms using PHQ-8 (eight-item Patient Health Questionnaire depression scale) and GAD-7 (Generalized Anxiety Disorder 7-item scale). PHQ-8 score >= 10 and/or GAD-7 score >= 10 are excluded.
(Past history of disorders not exclusionary). Interview
- Currently taking SSRI (selective serotonin reuptake inhibitor) medications for any reason. Interview
- Heart Diseases. Medical History Interview
- Hepatitis B or C positive status. Medical History Interview
- HIV positive status. Medical History Interview
- History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction. Medical History Interview
- 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
- Adherence to a vegan or vegetarian diet or to specialty/uncommon diets. Interview
- Food Allergies to tree nuts, soy, cocoa and cocoa-containing products. Interview
- People who choose to avoid caffeine intake. Interview
- Current or history of alcoholism or drug/chemical abuse as per Investigator's judgment. Medical History Interview
- Hormone Replacement Therapy; Currently pregnant; Pregnant or lactating within past 6 mos; Hormonal birth control (pill). Interview
- Smoking. Interview
- Unwilling to have blood drawn or anxiety/nausea during a blood draw. Interview.
- Uncomfortable completing memory and attention tasks in the English language. Interview
- MoCA (Montreal Cognitive Assessment) score less than 26. Montreal Cognitive Assessment
- Inability to swallow study capsules. Interview (at consent).
- 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
- Cardiac Pacemaker Interview
- Internal Pump Interview
- Insulin Pump Interview
- Tattoo eyeliner Interview
- Wire sutures Interview
- Internal Metal Objects Interview
- Metal Slivers in Eye Interview
- Prosthesis Interview
- Hearing Aid Implants Interview
- Neurostimulator Interview
- Metal Fragments Interview
- Brain Aneurysm Clips Interview
- Vascular Clips Interview
- Breast Expander Interview
- Vena Cava Filter Interview
- Heart Valve Interview
- Metal Stents Interview
- Asthma Interview
- Hay-Fever Interview
- Sickle Cell Disease Interview
- Kidney Disease Interview
- Pregnant Interview
- Claustrophobic Interview
- Wheelchair bound Interview
- Machinist or ever worked with heavy metals Interview
- 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 (Chronic obstructive pulmonary disease), 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
- Had more than one previous MRI scans with Gadolinium Interview
Sites / Locations
- Columbia University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Placebo Comparator
Active Comparator
Active Comparator
Active Comparator
F 0 mg
F 260 mg
F 510 mg
F 770 mg
daily consumption of capsules containing 0 mg cocoa flavanol for 12 weeks
daily consumption of capsules containing 260 mg* cocoa flavanol for 12 weeks *see note in Record Log regarding the change in the method of assessment of cocoa flavanol content of the capsules
daily consumption of capsules containing 510 mg cocoa flavanol for 12 weeks
daily consumption of capsules containing 770 mg cocoa flavanol for 12 weeks