Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dietary Modulation of Neuroinflammation in Age-Related Memory Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03723694
Recruitment Status : Recruiting
First Posted : October 29, 2018
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Richard Sloan, New York State Psychiatric Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Memory Loss Inflammation Dietary Supplement: 650 mg of Cocoapro flavanols Dietary Supplement: 0 mg of Cocoapro flavanols Not Applicable

Detailed 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Dietary Modulation of Neuroinflammation in Age-Related Memory Disorders
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : November 25, 2023
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
Active Comparator: 650 mg of Cocoapro flavanols
Daily, each subject will consume either two cocoa flavanol-containing capsules twice a day with a meal.
Dietary Supplement: 650 mg of Cocoapro flavanols
12-week period during which participant will be asked to consume two cocoa-flavanol-containing capsules(650mg) twice a day with meals.

Placebo Comparator: 0mg Cocoapro flavanols
Daily, each subject will consume either ttwo placebo-containing capsules twice a day with a meal.
Dietary Supplement: 0 mg of Cocoapro flavanols
12-week period during which participant will be asked to consume two cocoa-flavanol-containing capsules(0mg) twice a day with meals.




Primary Outcome Measures :
  1. HMGB1 [ Time Frame: 12 weeks ]
    circulating levels of the inflammatory marker HMGB1


Secondary Outcome Measures :
  1. NFkB [ Time Frame: 12 weeks ]
    TLR4-dependent NFkB

  2. TNFa [ Time Frame: 12 weeks ]
    TLR4-dependent TNFa


Other Outcome Measures:
  1. ModBent [ Time Frame: 12 weeks ]
    modified Benton Recognition Task

  2. ModRey [ Time Frame: 12 weeks ]
    Modified Rey Auditory Verbal Learning Test

  3. multiple cognitive domains [ Time Frame: 12 weeks ]
    NIH Toolbox Cognition Battery, which includes adaptive computerized tests of executive function, attention, episodic memory, language, processing speed, and working memory



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 screening or management of the subject).
  2. Healthy Male or Female subjects. (Females must be post-menopausal)
  3. Age between 50 and 69 years, both inclusive.
  4. Body mass index between 18.0 and 35 kg/m², both inclusive.

Exclusion Criteria:

  1. Currently undergoing medical treatment, including prescription drugs/medication.
  2. Clinically significant abnormal hematology, biochemistry, urinalysis, or coagulation screening tests, as judged by the Investigator.
  3. 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.
  4. 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
  5. Heart Diseases.
  6. Hepatitis B or C positive status.
  7. HIV positive status.
  8. History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
  9. 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.
  10. Adherence to a vegan or vegetarian diet or to specialty/uncommon diets.
  11. Food Allergies to tree nuts, soy, cocoa and cocoa-containing products.
  12. People who choose to avoid caffeine intake.
  13. Current or history of alcoholism or drug/chemical abuse as per Investigator's judgment.
  14. Hormone Replacement Therapy; Currently pregnant; Pregnant or Interview\ lactating within past 6 months; Hormonal birth control (pill).
  15. Smoking.
  16. Unwilling to have blood drawn or anxiety/nausea during a blood draw.
  17. Uncomfortable completing memory and attention tasks in the English language
  18. Montreal Cognitive Assessment (MoCA) score less than 26.
  19. Inability to swallow study capsules Interview (at Consent)
  20. 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

  1. Cardiac Pacemaker
  2. Internal Pump
  3. Insulin Pump
  4. Tattoo eyeliner
  5. Wire sutures
  6. Internal Metal Objects
  7. Metal Slivers in Eye
  8. Prosthesis
  9. Hearing Aid Implants
  10. Neurostimulator
  11. Metal Fragments
  12. Brain Aneurysm Clips
  13. Vascular Clips
  14. Breast Expander
  15. Vena Cava Filter
  16. Heart Valve
  17. Metal Stents
  18. Asthmatic symptoms within the past 3 years
  19. Sickle Cell Disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03723694


Locations
Layout table for location information
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Richard Sloan, PhD    646-774-8940    rps7@columbia.edu   
Contact: Richard Sloan, PhD    6467748940    rps7@columbia.edu   
Sponsors and Collaborators
New York State Psychiatric Institute
  Study Documents (Full-Text)

Documents provided by Richard Sloan, New York State Psychiatric Institute:
Informed Consent Form  [PDF] April 16, 2019

Publications:
Layout table for additonal information
Responsible Party: Richard Sloan, Nathaniel Wharton Professor of Behavioral Medicine, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT03723694    
Other Study ID Numbers: 7665
First Posted: October 29, 2018    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Memory Disorders
Inflammation
Pathologic Processes
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases