Dietary Modulation of Neuroinflammation in Age-Related Memory Disorders

  • STATUS
    Recruiting
  • End date
    Jun 30, 2024
  • participants needed
    146
  • sponsor
    New York State Psychiatric Institute
Updated on 11 July 2021
body mass index
memory disorders
age-related memory disorders
flavanol

Summary

To test the effect of a cocoa-derived dietary flavanol 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. We also will examine the role of inflammation in this relationship.

Description

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.

Details
Condition Amnesia, Inflammation, Memory impairment, Memory Loss, loss of memory
Treatment 650 mg of Cocoapro flavanols, 0 mg of Cocoapro flavanols
Clinical Study IdentifierNCT03723694
SponsorNew York State Psychiatric Institute
Last Modified on11 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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)
Healthy Male or Female subjects. (Females must be post-menopausal)
Age between 50 and 69 years, both inclusive
Body mass index between 18.0 and 35 kg/m, both inclusive

Exclusion Criteria

Currently undergoing medical treatment, including prescription drugs/medication
Clinically significant abnormal hematology, biochemistry, urinalysis, or coagulation screening tests, as judged by the Investigator
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
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
Heart Diseases
Hepatitis B or C positive status
HIV positive status
History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction
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
Adherence to a vegan or vegetarian diet or to specialty/uncommon diets
Food Allergies to tree nuts, soy, cocoa and cocoa-containing products
People who choose to avoid caffeine intake
Current or history of alcoholism or drug/chemical abuse as per Investigator's judgment
Hormone Replacement Therapy; Currently pregnant; Pregnant or Interview\ lactating within past 6 months; Hormonal birth control (pill)
Smoking
Unwilling to have blood drawn or anxiety/nausea during a blood draw
Uncomfortable completing memory and attention tasks in the English language
Montreal Cognitive Assessment (MoCA) score less than 26
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)
MRI RELATED
Cardiac Pacemaker
Internal Pump
Insulin Pump
Tattoo eyeliner
Wire sutures
Internal Metal Objects
Metal Slivers in Eye
Prosthesis
Hearing Aid Implants
Neurostimulator
Metal Fragments
Brain Aneurysm Clips
Vascular Clips
Breast Expander
Vena Cava Filter
Heart Valve
Metal Stents
Asthmatic symptoms within the past 3 years
Sickle Cell Disease
Clear my responses

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