Dietary Flavanols and Dentate Gyrus Function

Completed · Not applicable

Conditions studied: Memory Loss

In brief

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

Key facts

Study ID

NCT02312310

Run by

New York State Psychiatric Institute

People needed

211

Starts

2015-12-01

Expected to finish

2020-04-01

Last updated by the study team

2020-06-11

Who can join

Age: 50 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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
• Healthy Male or Female subjects. (Females must be post-menopausal) Telephone Screen
• Age between 50 and 75 years, both inclusive. Telephone Screen
• Body mass index between 18.0 and 35 kg/m², both inclusive. Telephone Screen

You may not qualify if…

• 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

Where it is running

• Columbia University Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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