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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
259
12-week period during which participant will be asked to consume two cocoa-flavanol-containing capsules(650mg) twice a day with meals.
12-week period during which participant will be asked to consume two cocoa-flavanol-containing capsules(0mg) twice a day with meals.
Columbia University Irving Medical Center
New York, New York, United States
HMGB1
circulating levels of the inflammatory marker HMGB1
Time frame: 12 weeks
NFkB
TLR4-dependent NFkB
Time frame: 12 weeks
TNFa
TLR4-dependent TNFa
Time frame: 12 weeks
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