Dietary Cocoa Flavanols and Age-Related Memory Decline
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 211
- 试验地点
- 1
- 主要终点
- Modified Benton Recognition Task (ModBent)
研究概览
简要总结
to assess the effect of differing amounts of a cocoa-derived dietary flavanol (epicatechin ) on dentate gyrus function and corresponding cognitive function
详细描述
In this double blinded trial, the participants, age 50-75 years, will be randomized to receive 0, 260, 510, or 770 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 (functional magnetic resonance imaging) 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.
*see note in Record Log regarding the change in the method of assessment of cocoa flavanol content of the capsules
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
- •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
- 另有 2 项未显示
结局指标
主要结局
Modified Benton Recognition Task (ModBent)
时间窗: baseline and 12 weeks
The ModBent task is divided into two parts. During the matching trials (top), participants were shown a complex stimulus for 10 s. Following a 1-s inter-trial interval, they were required to select, via a key press, which of two stimuli matched the one they had just studied, as quickly and as accurately as possible. Following 41 matching trials, participants were shown a series of 82 stimuli (bottom), 41 of which appeared on the initial study set during the matching trials and 41 of which were foils. They were required to indicate, as quickly as possible, whether each stimulus appeared earlier (yes response) or was new (no response). The primary variable of the ModBent task is the mean RT for correct rejections of foils during the recognition trials
次要结局
- Dentate Gyrus Cerebral Blood Volume(baseline and 12 weeks)
- NIH Toolbox Cognition Battery (NIHTB-CB): The List Sorting Test(Baseline and 12 Weeks)
- Modified Benton Recognition Task (ModBent)(20 weeks)
- Modified Rey Auditory Verbal Learning Test(Baseline and 12 Weeks)
研究者
Richard Sloan
Research Scientist / Professor of Behavioral Medicine (in Psychiatry)
New York State Psychiatric Institute