Dietary Modulation of Neuroinflammation in Age-Related Memory Disorders

NCT03723694 | Completed

• 2 other identifiers: NYSPI 76655R01AG058417
• Study Type: interventional
• Target: 259
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is 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. Th investigators will also examine the role of inflammation in this relationship.

Conditions

Memory Loss; Inflammation

Keywords

Flavanol; Cocoapro

Outcome Measures

Primary Outcomes (1)

• HMGB1

  circulating levels of the inflammatory marker HMGB1

  12 weeks

Secondary Outcomes (2)

• NFkB

  12 weeks

• TNFa

  12 weeks

Other Outcomes (3)

• ModBent

  12 weeks

• ModRey

  12 weeks

• multiple cognitive domains

  12 weeks

Study Arms (2)

650 mg of Cocoapro flavanols

ACTIVE COMPARATOR

Daily, each subject will consume either two cocoa flavanol-containing capsules twice a day with a meal.

Dietary Supplement: 650 mg of Cocoapro flavanols

0mg Cocoapro flavanols

PLACEBO COMPARATOR

Daily, each subject will consume either ttwo placebo-containing capsules twice a day with a meal.

Dietary Supplement: 0 mg of Cocoapro flavanols

Interventions

650 mg of Cocoapro flavanols DIETARY_SUPPLEMENT

12-week period during which participant will be asked to consume two cocoa-flavanol-containing capsules(650mg) twice a day with meals.

650 mg of Cocoapro flavanols

0 mg of Cocoapro flavanols DIETARY_SUPPLEMENT

12-week period during which participant will be asked to consume two cocoa-flavanol-containing capsules(0mg) twice a day with meals.

0mg Cocoapro flavanols

Eligibility Criteria

• Age: 50 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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/m², both inclusive.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Related Publications (1)

• 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.

  PMID: 25344629 BACKGROUND

MeSH Terms

Conditions

Memory Disorders; Inflammation

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Richard P. Sloan, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nathaniel Wharton Professor of Behavioral Medicine

Study Record Dates

• First Submitted: October 24, 2018
• First Posted: October 29, 2018
• Study Start: January 1, 2019
• Primary Completion: March 5, 2023
• Study Completion: June 26, 2023
• Last Updated: August 27, 2024

Record last verified: 2024-08

Locations

US (1)