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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01AG058417 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 650 mg of Cocoapro flavanols | Active Comparator | Daily, each subject will consume either two cocoa flavanol-containing capsules twice a day with a meal. |
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| 0mg Cocoapro flavanols | Placebo Comparator | Daily, each subject will consume either ttwo placebo-containing capsules twice a day with a meal. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| HMGB1 | circulating levels of the inflammatory marker HMGB1 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| NFkB | TLR4-dependent NFkB | 12 weeks |
| TNFa | TLR4-dependent TNFa | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| ModBent | modified Benton Recognition Task | 12 weeks |
| ModRey | Modified Rey Auditory Verbal Learning Test | 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
MRI RELATED
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| Name | Affiliation | Role |
|---|---|---|
| Richard P. Sloan, PhD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Irving Medical Center | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25344629 | Background | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 16, 2025 | |
| Reset | Feb 7, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 16, 2025 | Feb 7, 2025 |
| ID | Term |
|---|---|
| D008569 | Memory Disorders |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| 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. |
|
| 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 |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |