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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

Tracking Information
First Submitted Date  ICMJE October 24, 2018
First Posted Date  ICMJE October 29, 2018
Last Update Posted Date June 4, 2020
Actual Study Start Date  ICMJE January 1, 2019
Estimated Primary Completion Date November 25, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 25, 2018)
HMGB1 [ Time Frame: 12 weeks ]
circulating levels of the inflammatory marker HMGB1
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2018)
  • NFkB [ Time Frame: 12 weeks ]
    TLR4-dependent NFkB
  • TNFa [ Time Frame: 12 weeks ]
    TLR4-dependent TNFa
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 2, 2019)
  • ModBent [ Time Frame: 12 weeks ]
    modified Benton Recognition Task
  • ModRey [ Time Frame: 12 weeks ]
    Modified Rey Auditory Verbal Learning Test
  • 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
Original Other Pre-specified Outcome Measures
 (submitted: October 25, 2018)
  • ModBent [ Time Frame: 12 weeks ]
    modified Benton Recognition Task
  • 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
 
Descriptive Information
Brief Title  ICMJE Dietary Modulation of Neuroinflammation in Age-Related Memory Disorders
Official Title  ICMJE Dietary Modulation of Neuroinflammation in Age-Related Memory Disorders
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE
  • Memory Loss
  • Inflammation
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Active Comparator: 650 mg of Cocoapro flavanols
    Daily, each subject will consume either two cocoa flavanol-containing capsules twice a day with a meal.
    Intervention: Dietary Supplement: 650 mg of Cocoapro flavanols
  • Placebo Comparator: 0mg Cocoapro flavanols
    Daily, each subject will consume either ttwo placebo-containing capsules twice a day with a meal.
    Intervention: Dietary Supplement: 0 mg of Cocoapro flavanols
Publications * Brickman AM, Khan UA, Provenzano FA, Yeung LK, Suzuki W, Schroeter H, Wall M, Sloan RP, Small SA. Enhancing dentate gyrus function with dietary flavanols improves cognition in older adults. Nat Neurosci. 2014 Dec;17(12):1798-803. doi: 10.1038/nn.3850. Epub 2014 Oct 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 25, 2018)
146
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2024
Estimated Primary Completion Date November 25, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03723694
Other Study ID Numbers  ICMJE 7665
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Richard Sloan, New York State Psychiatric Institute
Study Sponsor  ICMJE New York State Psychiatric Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account New York State Psychiatric Institute
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP