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Dietary Modulation of Neuroinflammation in Age-Related Memory Disorders

Recruiting

In this study investigators will test the effects of a compound derived from cocoa, known as a flavanol, on brain structures, cognition, and inflammation in older adults without memory problems. 

Minimum Age Maximum Age Gender Healthy Volunteers
50 Years 69 Years All Yes
January 1, 2019
June 30, 2024
146

  • Females must be post-menopausal
  • Body mass index between 18 and 35

  • Currently undergoing medical treatment, including prescription drugs/medication
  • Significant abnormal values on blood, urine, and other screening tests
  • History or presence of cancer (except basal cell skin cancer or squamous cell skin cancer)
  • Any significant heart, lung, metabolic, kidney, liver, gastrointestinal, endocrinological (with the exception euthyroid struma), blood, skin, venereal, neurological, psychiatric diseases, or other major disorders
  • Seated blood pressure (after resting for 5 minutes in seated position) outside the range of 90 to 140 mmHg for systolic or 50 to 90 mmHg for diastolic and/or resting heart rate when lying horizontally outside the range of 50 to 90 beats per minute
  • Heart diseases
  • Hepatitis B or C positive status
  • HIV positive
  • History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction
  • Use of nonprescription medication, herbal products, or nutritional supplements during the study, and within 4 weeks of study start; occasional use of aspirin, ibuprofen, and acetaminophen permitted
  • Adherence to a vegan or vegetarian diet or to specialty/uncommon diets
  • 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
  • Currently pregnant or lactating within past 6 months
  • Hormone replacement therapy or taking birth control pills
  • Smoking
  • Ability to complete memory and attention tasks in English
  • Montreal Cognitive Assessment score less than 26
  • Metal implants or other conditions that would interfere with ability to undergo magnetic resonance imaging, including cardiac pacemaker, internal pump, insulin pump, tattoo eyeliner, wire sutures, prosthesis, hearing aid implants, asthmatic symptoms within the past 3 years, sickle cell disease

Participants will take a capsule with either 650mg of cocoa derivative or a placebo twice a day with a meal for 12 weeks. 

Name City State Zip Status Primary Contact
Columbia University Medical Center
New York New York 10032 Recruiting Richard Sloan, PhD
646-774-8940
rps7@columbia.edu

New York State Psychiatric Institute

NCT03723694

Dietary Modulation of Neuroinflammation in Age-Related Memory Disorders