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Cocoa Supplementation, Inflammaging, and Epigenetic Aging

Primary Purpose

Aging, Inflammation, Cardiovascular Diseases

Status
Active
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Cocoa extract
Multivitamin
Cocoa extract placebo
Multivitamin placebo
Sponsored by
Augusta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Aging

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Inclusion Criteria:

  • Provided blood samples at baseline, Year 1, and Year 2 of follow-up.
  • Opted to use EMSI for longitudinal blood collections, during which seated BPs were additionally measured.

Exclusion Criteria:

• Did not collect blood samples at baseline, Year 1, or Year 2 of follow-up.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    Cocoa extract + multivitamin

    Cocoa extract + multivitamin placebo

    Cocoa extract placebo + multivitamin

    Cocoa extract placebo + multivitamin placebo

    Arm Description

    Two capsules/day for 600 mg/day of cocoa flavanols One tablet/day of multivitamin

    Two capsules/day for 600 mg/day of cocoa flavanols Multivitamin placebo

    Cocoa extract placebo One tablet/day of multivitamin

    Cocoa extract placebo Multivitamin placebo

    Outcomes

    Primary Outcome Measures

    Epigenetic age acceleration
    A cumulative epigenetic aging index (DNAm age) that predicts DNAm age will be calculated. The residual from regressing DNAm age on chronological age provides a measure of epigenetic age acceleration.
    Inflammaging
    An index constructed using several inflammation markers reflecting inflammaging.

    Secondary Outcome Measures

    Blood pressure
    Systolic and diastolic blood pressure in mmHg.
    Body mass index
    Body mass index in kg/m2 will be calculated using height and weight
    Pulse wave velocity
    Pulse wave velocity in m/s from the carotid to the femoral artery will be measured.

    Full Information

    First Posted
    September 15, 2021
    Last Updated
    August 19, 2022
    Sponsor
    Augusta University
    Collaborators
    Brigham and Women's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05510375
    Brief Title
    Cocoa Supplementation, Inflammaging, and Epigenetic Aging
    Official Title
    Effect of Randomized Cocoa Supplementation on Inflammaging and Epigenetic Aging
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Active, not recruiting
    Study Start Date
    June 2015 (Actual)
    Primary Completion Date
    July 2022 (Actual)
    Study Completion Date
    September 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Augusta University
    Collaborators
    Brigham and Women's Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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 mg/d flavanols, including 80 mg. (-)-epicatechins), and 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 is being conducted among participants in COSMOS and will examine whether the cocoa extract supplement or the multivitamin supplement has an anti-aging effect (epigenetic aging and inflammaging) and examining these findings in the context of CVD risk factors and outcomes.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Aging, Inflammation, Cardiovascular Diseases

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Factorial Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    21442 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cocoa extract + multivitamin
    Arm Type
    Active Comparator
    Arm Description
    Two capsules/day for 600 mg/day of cocoa flavanols One tablet/day of multivitamin
    Arm Title
    Cocoa extract + multivitamin placebo
    Arm Type
    Active Comparator
    Arm Description
    Two capsules/day for 600 mg/day of cocoa flavanols Multivitamin placebo
    Arm Title
    Cocoa extract placebo + multivitamin
    Arm Type
    Active Comparator
    Arm Description
    Cocoa extract placebo One tablet/day of multivitamin
    Arm Title
    Cocoa extract placebo + multivitamin placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Cocoa extract placebo Multivitamin placebo
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Cocoa extract
    Intervention Description
    2 capsules each day containing a total of 500 mg cocoa flavanols, including 80 mg (-)-epicatechin, and 50 mg theobromine
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Multivitamin
    Intervention Description
    Multivitamin
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Cocoa extract placebo
    Intervention Description
    Cocoa extract placebo
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Multivitamin placebo
    Intervention Description
    Multivitamin placebo
    Primary Outcome Measure Information:
    Title
    Epigenetic age acceleration
    Description
    A cumulative epigenetic aging index (DNAm age) that predicts DNAm age will be calculated. The residual from regressing DNAm age on chronological age provides a measure of epigenetic age acceleration.
    Time Frame
    2 years
    Title
    Inflammaging
    Description
    An index constructed using several inflammation markers reflecting inflammaging.
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    Blood pressure
    Description
    Systolic and diastolic blood pressure in mmHg.
    Time Frame
    2 years
    Title
    Body mass index
    Description
    Body mass index in kg/m2 will be calculated using height and weight
    Time Frame
    2 years
    Title
    Pulse wave velocity
    Description
    Pulse wave velocity in m/s from the carotid to the femoral artery will be measured.
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Participants in COSMOS (NCT02422745) who meet the following criteria are eligible to participate in this ancillary study: Inclusion Criteria: Provided blood samples at baseline, Year 1, and Year 2 of follow-up. Opted to use EMSI for longitudinal blood collections, during which seated BPs were additionally measured. Exclusion Criteria: • Did not collect blood samples at baseline, Year 1, or Year 2 of follow-up.

    12. IPD Sharing Statement

    Learn more about this trial

    Cocoa Supplementation, Inflammaging, and Epigenetic Aging

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