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COSMOS Web: Investigating the Effects of Cocoa Flavanol on Cognition Assessed Online

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ClinicalTrials.gov Identifier: NCT04582617
Recruitment Status : Active, not recruiting
First Posted : October 9, 2020
Last Update Posted : January 22, 2021
Sponsor:
Collaborators:
Brigham and Women's Hospital
Fred Hutchinson Cancer Research Center
Mars, Inc.
Information provided by (Responsible Party):
Adam Brickman, Columbia University

Tracking Information
First Submitted Date  ICMJE October 2, 2019
First Posted Date  ICMJE October 9, 2020
Last Update Posted Date January 22, 2021
Actual Study Start Date  ICMJE August 26, 2016
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2020)
ModRey: 1-Year Change in Immediate Recall/Learning/Episodic Memory [ Time Frame: 1-year follow-up ]
A measure of verbal memory. The change in the number of words recalled immediately on the ModRey task (Hale et al., 2019), after one year of cocoa extract/placebo intervention.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2021)
  • ModRey: Longitudinal Change in Immediate Recall/Learning [ Time Frame: 2-year and 3-year follow-ups ]
    A measure of verbal memory. Change in number of words recalled immediately on the ModRey task.
  • ModBent [ Time Frame: 1-year, 2-year and 3-year follow-ups ]
    A measure of pattern separation/object recognition. Change in the mean response time on correct rejection trials on a delayed recognition task.
  • Flanker: Directional Flanker Effect [ Time Frame: 1-year, 2-year and 3-year follow-ups ]
    A measure of executive control. Change in the difference in reaction time (in ms) between directionally congruent and directional incongruent trials in a Flanker task.
  • Spatial Reconstruction: Distortion [ Time Frame: 1-year, 2-year and 3-year follow-ups ]
    A measure of spatial memory. Change in the proportion of stimulus pairs where their relative locations are reconstructed differently than originally shown
  • Self-Reported Memory Change [ Time Frame: 1-year, 2-year and 3-year follow-ups ]
    Self-report of memory change in the last year, on a scale of 1-7
  • In-clinic ModBent [ Time Frame: 2-year follow-up ]
    Change in performance on the ModBent task, administered in-clinic to a subset of 200 participants
  • Interaction of Baseline Diet & Intervention on the ModRey [ Time Frame: 1-year, 2-year and 3-year follow-ups ]
    Interaction of baseline diet (as assessed by the Food Frequency Questionnaire) with the flavanol/multivitamin interventions on the ModRey, a measure of verbal memory (change in number of words recalled)
  • Hippocampal volume change [ Time Frame: 2-year follow-up ]
    Change in hippocampus volume (in cubic mm) in subset of participants with in-clinic MRI scan
  • Global cortical thickness change [ Time Frame: 2-year follow-up ]
    Change in average cortical thickness in the whole brain (in mm) in subset of participants with in-clinic MRI scan
  • Hippocampal cerebral blood volume change [ Time Frame: 2-year follow-up ]
    Change in cerebral blood volume in the hippocampus (in cubic mm) in subset of participants with in-clinic MRI scan
  • Proportions of words recalled on in-clinic list learning task [ Time Frame: 2-year follow-up ]
    Proportions of words recalled on list learning task for subset of participants with in-clinic cognitive testing
Original Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2020)
  • ModRey: Longitudinal Change in Immediate Recall/Learning [ Time Frame: 2-year and 3-year follow-ups ]
    A measure of verbal memory. Change in number of words recalled immediately on the ModRey task.
  • ModBent [ Time Frame: 1-year, 2-year and 3-year follow-ups ]
    A measure of pattern separation/object recognition. Change in the mean response time on correct rejection trials on a delayed recognition task.
  • Flanker: Directional Flanker Effect [ Time Frame: 1-year, 2-year and 3-year follow-ups ]
    A measure of executive control. Change in the difference in reaction time (in ms) between directionally congruent and directional incongruent trials in a Flanker task.
  • Spatial Reconstruction: Distortion [ Time Frame: 1-year, 2-year and 3-year follow-ups ]
    A measure of spatial memory. Change in the proportion of stimulus pairs where their relative locations are reconstructed differently than originally shown
  • Self-Reported Memory Change [ Time Frame: 1-year, 2-year and 3-year follow-ups ]
    Self-report of memory change in the last year, on a scale of 1-7
  • In-clinic ModBent [ Time Frame: 2-year follow-up ]
    Change in performance on the ModBent task, administered in-clinic to a subset of 200 participants
  • Interaction of Baseline Diet & Intervention on the ModRey [ Time Frame: 1-year, 2-year and 3-year follow-ups ]
    Interaction of baseline diet (as assessed by the Food Frequency Questionnaire) with the flavanol/multivitamin interventions on the ModRey, a measure of verbal memory (change in number of words recalled)
  • Hippocampal volume change [ Time Frame: 2-year follow-up ]
    Change in hippocampus volume (in cubic millimeters) in subset of participants with in-clinic MRI scan
  • Global cortical thickness change [ Time Frame: 2-year follow-up ]
    Change in average cortical thickness in the whole brain (in milimeters) in subset of participants with in-clinic MRI scan
  • Hippocampal cerebral blood volume change [ Time Frame: 2-year follow-up ]
    Change in cerebral blood volume in the hippocampus (in cubic millimeters) in subset of participants with in-clinic MRI scan
  • Proportions of words recalled on in-clinic list learning task [ Time Frame: 2-year follow-up ]
    Proportions of words recalled on list learning task for subset of participants with in-clinic cognitive testing
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE COSMOS Web: Investigating the Effects of Cocoa Flavanol on Cognition Assessed Online
Official Title  ICMJE COSMOS Web: Investigating the Effects of Cocoa Flavanol on Cognition Assessed Online
Brief Summary The COcoa Supplement and Multivitamin Outcomes Study (COSMOS; NCT02422745) is a randomized clinical trial of cocoa extract supplement (containing a total of 600 mg/d flavanols, including 80 mg (-)-epicatechin), and/or 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 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 function/working 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 21,444 older adult participants into cocoa extract and placebo interventions, the study team at Brigham and Women's 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 Women's 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Aging
  • Cognitive Change
Intervention  ICMJE
  • Dietary Supplement: Cocoa Extract
    2 capsules each day containing a total of 600 mg cocoa flavanols, including 80 mg (-)-epicatechin, and 50 mg theobromine
  • Dietary Supplement: Cocoa Extract Placebo
    Cocoa extract placebo
  • Dietary Supplement: Multivitamin
    Multivitamin
  • Dietary Supplement: Multivitamin placebo
    Multivitamin placebo
Study Arms  ICMJE
  • Active Comparator: Cocoa extract + multivitamin
    Interventions:
    • Dietary Supplement: Cocoa Extract
    • Dietary Supplement: Multivitamin
  • Active Comparator: Cocoa extract + multivitamin placebo
    Interventions:
    • Dietary Supplement: Cocoa Extract
    • Dietary Supplement: Multivitamin placebo
  • Active Comparator: Cocoa extract placebo + multivitamin
    Interventions:
    • Dietary Supplement: Cocoa Extract Placebo
    • Dietary Supplement: Multivitamin
  • Placebo Comparator: Cocoa extract placebo + multivitamin placebo
    Interventions:
    • Dietary Supplement: Cocoa Extract Placebo
    • Dietary Supplement: Multivitamin placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 5, 2020)
3947
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2021
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Participants in COSMOS (NCT02422745) who meet the following criteria are eligible to participate in this ancillary study:

Inclusion Criteria:

  • Willingness to participate
  • Email and internet access via computer

Exclusion Criteria:

* Analog to COSMOS parent trial

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04582617
Other Study ID Numbers  ICMJE AAAQ8029
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Researchers interested in study data may contact the study principal investigators to request access. Data requests must be submitted in writing for approval by qualified individuals; they will be reviewed by study investigators. External investigators who are granted access to data for analysis must identify a Cosmos Web investigator, who will participate in analyses and manuscript preparation as a co-author. Researchers interested in accessing data related to the Cosmos parent trial (NCT02422745) should contact the administrators of that study.
Supporting Materials: Study Protocol
Supporting Materials: Informed Consent Form (ICF)
Time Frame: After completion of study
Access Criteria: Cosmos-Web Project Proposal Form Approved by Dr. Brickman
Responsible Party Adam Brickman, Columbia University
Study Sponsor  ICMJE Columbia University
Collaborators  ICMJE
  • Brigham and Women's Hospital
  • Fred Hutchinson Cancer Research Center
  • Mars, Inc.
Investigators  ICMJE
Principal Investigator: Adam M Brickman, PhD Columbia University
Principal Investigator: Scott A Small, MD Columbia University
PRS Account Columbia University
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP