NCT03723694

Dietary Modulation of Neuroinflammation in Age-Related Memory Disorders

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 259 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 50 Years – 69 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Memory Loss
• Inflammation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-01-01
• Primary completion: 2023-03-05
• Completion: 2023-06-26
• First posted: 2018-10-29
• Last updated: 2024-08-27

Locations

1 site across 1 country: United States