Dietary Modulation of Neuroinflammation in Age-Related Memory Disorders

Inflammation Clinical Trial

Official title:

Dietary Modulation of Neuroinflammation in Age-Related Memory Disorders

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03723694
• Other study ID #: NYSPI 7665
• Secondary ID: 5R01AG058417
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 146
• Est. completion date: December 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Memory Disorders
• Memory Loss

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	ModBent	modified Benton Recognition Task	12 weeks
Other	ModRey	Modified Rey Auditory Verbal Learning Test	12 weeks
Other	multiple cognitive domains	NIH Toolbox Cognition Battery, which includes adaptive computerized tests of executive function, attention, episodic memory, language, processing speed, and working memory	12 weeks
Primary	HMGB1	circulating levels of the inflammatory marker HMGB1	12 weeks
Secondary	NFkB	TLR4-dependent NFkB	12 weeks
Secondary	TNFa	TLR4-dependent TNFa	12 weeks