N/A
N=211
Dietary Flavanols and Dentate Gyrus Function
Memory Loss
Bottom Line
View on ClinicalTrials.gov: NCT02312310 ↗Enrolled (actual)
211
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcome: Primary: Modified Benton Recognition Task (ModBent) — 2807.98; 2579.94; 2603.65; 2732.79 ms — p=.393
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cocoa Flavanol (Dietary_supplement)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- New York State Psychiatric Institute
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Modified Benton Recognition Task (ModBent) |
2542.76; 2475.35; 2373.78; 2550.18 | — |
| SECONDARY Dentate Gyrus Cerebral Blood Volume |
2.44; 2.17; 2.11; 1.85; 2.25; 2.11 | — |
| SECONDARY Modified Benton Recognition Task (ModBent) |
2542.76; 2475.35; 2373.78; 2550.18 | — |
| SECONDARY Modified Rey Auditory Verbal Learning Test |
38.91; 37.25; 39.75; 39.96; 39.49; 38.69 | — |
| SECONDARY NIH Toolbox Cognition Battery (NIHTB-CB): The List Sorting Test |
52.89; 56.81; 54.60; 55.18; 53.34; 56.10 | — |
Summary
to assess the effect of differing amounts of a cocoa-derived dietary flavanol (epicatechin ) on dentate gyrus function and corresponding cognitive function
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
- 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
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 Inter
Data sourced from ClinicalTrials.gov (NCT02312310). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.