Ignite Creation Date:
2024-05-06 @ 3:18 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04582617
Status:
COMPLETED
Last Update Posted:
2023-04-07
First Post:
2019-10-02
Brief Title:
Investigating the Effects of Cocoa Flavanol on Cognition Assessed Online
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
COSMOS Web Investigating the Effects of Cocoa Flavanol on Cognition Assessed Online
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COSMOS-Web
Brief Summary:
The COcoa Supplement and Multivitamin Outcomes Study COSMOS NCT02422745 is a randomized clinical trial of cocoa extract supplement containing a total of 500 mgd flavanols including 80 mg --epicatechin andor a standard multivitamin supplement to reduce the risk of cardiovascular disease and cancer among men aged 60 years and older and women aged 65 years and older This ancillary study COSMOS Web is being conducted among a subset of participants in COSMOS and will examine whether the cocoa extract supplements affects cognitive function in older adults
Detailed Description:
The goal of the COSMOS Web study is to determine whether a dietary intervention with flavanol-containing cocoa extract has an effect on cognitive function in older adults age 60 The study will be conducted in a subset of 4000 participants from the COSMOS study NCT02422745 The investigators recent work Sloan et al submitted showed that cocoa flavanol consumption over 12 weeks led to improvements in immediate recall on the ModRey verbal memory task in healthy older adults
In COSMOS Web the investigators are testing the effect of a dietary intervention with flavanol-containing cocoa extract on a range of aging-related cognitive measures as assessed through a novel online-administered test battery in a cohort of older participants Change in ModRey Modified Rey Auditory Verbal Learning Test immediate recall performance over 1 year of cocoa extract consumption will be our primary outcome measure Secondary endpoints will include change in ModRey performance at 2- and 3-year follow-up and change in performance tests of a novel object recognition task executive functionworking memory and spatial memory at 1- 2- and 3- years follow-up This study will explore whether baseline measures of cognition and nutritional status can predict differential effects of the cocoa extract supplementation This study will also explore the effect of multivitamin intake on the primary and secondary outcomes noted above and test whether multivitamin intake interacts with flavanol intake from cocoa extract to enhance or mitigate effects on cognitive outcomes In a subset of participants evaluated in person this study will examine the impact of cocoa extract intake and explore the main and interacting effects of multivitamins on cognitive changes and brain structure and function appreciated with magnetic resonance imaging over a 2-year period
Leveraging the COSMOS study which has randomized 21442 older adult participants into cocoa extract and placebo interventions the study team at Brigham and Womens Hospital who administer the parent COSMOS trial are recruiting 4000 older adult volunteers to participate in COSMOS Web this study an online cognitive testing battery developed by the team at Columbia University These 4000 participants will complete an initial online cognitive assessment and additional assessments after one two and three years of follow-up In addition approximately 200 COSMOS Web participants who live in the Boston area will complete clinic-based study visits at the Clinical and Translational Science Center at Brigham and Womens Hospital During that visit they will complete a neuropsychological test battery for comparison to their performance online This study will examine the impact of dietary interventions with cocoa extract and explore the main and interacting effects of multivitamin intake on cognitive changes and brain structure and function appreciated with magnetic resonance imaging over a 2-year period
After the COSMOS trial began an advanced method to analyze cocoa flavanols was accredited by AOAC International as a First Action Official Method of Analysis httpsdoiorg101093jaoacintqsaa132 This updated method relies on a reference material RM8403 recently standardized and made commercially available by the US National Institute of Standards and Technology While the actual cocoa flavanol content of the COSMOS intervention remained unchanged throughout the trial the application of this new analytical method led to expected changes in how the total cocoa flavanol content is now reported Applying AOAC 202005RM8403 to the COSMOS intervention the total cocoa flavanol content of the COSMOS intervention is now 500 mgday Reporting of --epicatechin content remained unaffected Going forward we will therefore apply AOAC 202005RM8403 and report that the COSMOS intervention tested 500 mgday of cocoa flavanols including 80 mg of --epicatechin
In COSMOS Web the investigators are testing the effect of a dietary intervention with flavanol-containing cocoa extract on a range of aging-related cognitive measures as assessed through a novel online-administered test battery in a cohort of older participants Change in ModRey Modified Rey Auditory Verbal Learning Test immediate recall performance over 1 year of cocoa extract consumption will be our primary outcome measure Secondary endpoints will include change in ModRey performance at 2- and 3-year follow-up and change in performance tests of a novel object recognition task executive functionworking memory and spatial memory at 1- 2- and 3- years follow-up This study will explore whether baseline measures of cognition and nutritional status can predict differential effects of the cocoa extract supplementation This study will also explore the effect of multivitamin intake on the primary and secondary outcomes noted above and test whether multivitamin intake interacts with flavanol intake from cocoa extract to enhance or mitigate effects on cognitive outcomes In a subset of participants evaluated in person this study will examine the impact of cocoa extract intake and explore the main and interacting effects of multivitamins on cognitive changes and brain structure and function appreciated with magnetic resonance imaging over a 2-year period
Leveraging the COSMOS study which has randomized 21442 older adult participants into cocoa extract and placebo interventions the study team at Brigham and Womens Hospital who administer the parent COSMOS trial are recruiting 4000 older adult volunteers to participate in COSMOS Web this study an online cognitive testing battery developed by the team at Columbia University These 4000 participants will complete an initial online cognitive assessment and additional assessments after one two and three years of follow-up In addition approximately 200 COSMOS Web participants who live in the Boston area will complete clinic-based study visits at the Clinical and Translational Science Center at Brigham and Womens Hospital During that visit they will complete a neuropsychological test battery for comparison to their performance online This study will examine the impact of dietary interventions with cocoa extract and explore the main and interacting effects of multivitamin intake on cognitive changes and brain structure and function appreciated with magnetic resonance imaging over a 2-year period
After the COSMOS trial began an advanced method to analyze cocoa flavanols was accredited by AOAC International as a First Action Official Method of Analysis httpsdoiorg101093jaoacintqsaa132 This updated method relies on a reference material RM8403 recently standardized and made commercially available by the US National Institute of Standards and Technology While the actual cocoa flavanol content of the COSMOS intervention remained unchanged throughout the trial the application of this new analytical method led to expected changes in how the total cocoa flavanol content is now reported Applying AOAC 202005RM8403 to the COSMOS intervention the total cocoa flavanol content of the COSMOS intervention is now 500 mgday Reporting of --epicatechin content remained unaffected Going forward we will therefore apply AOAC 202005RM8403 and report that the COSMOS intervention tested 500 mgday of cocoa flavanols including 80 mg of --epicatechin
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None