AgingPhase 4NCT05510375
Cocoa Supplementation, Inflammaging, and Epigenetic Aging
A Phase 4 study testing Cocoa extract and Multivitamin in people with Aging and Inflammation, run by Augusta University.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Inflammation, Cardiovascular Diseases
- What is being tested?
- Cocoa extract and Multivitamin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21,442 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to 30 Sep 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Did not collect blood samples at baseline, Year 1, or Year 2 of follow-up.
About this study
Official title: Effect of Randomized Cocoa Supplementation on Inflammaging and Epigenetic Aging
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.
- Conditions
- Aging, Inflammation, Cardiovascular Diseases
- Being tested
- Cocoa extract, Multivitamin, Cocoa extract placebo, Multivitamin placebo
- Medical subject headings
- Inflammation, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cocoa extractDietary supplement
2 capsules each day containing a total of 500 mg cocoa flavanols, including 80 mg (-)-epicatechin, and 50 mg theobromine
MultivitaminDietary supplement
Multivitamin
Cocoa extract placeboDietary supplement
Cocoa extract placebo
Multivitamin placeboDietary supplement
Multivitamin placebo
| Study group | Role | What they receive |
|---|---|---|
| Cocoa extract + multivitamin | Active comparator | Two capsules/day for 600 mg/day of cocoa flavanols One tablet/day of multivitamin Receives: Dietary Supplement: Cocoa extract; Dietary Supplement: Multivitamin |
| Cocoa extract + multivitamin placebo | Active comparator | Two capsules/day for 600 mg/day of cocoa flavanols Multivitamin placebo Receives: Dietary Supplement: Cocoa extract; Dietary Supplement: Multivitamin placebo |
| Cocoa extract placebo + multivitamin | Active comparator | Cocoa extract placebo One tablet/day of multivitamin Receives: Dietary Supplement: Multivitamin; Dietary Supplement: Cocoa extract placebo |
| Cocoa extract placebo + multivitamin placebo | Placebo comparator | Cocoa extract placebo Multivitamin placebo Receives: Dietary Supplement: Cocoa extract placebo; Dietary Supplement: Multivitamin placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Inflammaging
An index constructed using several inflammation markers reflecting inflammaging.
Measured: 2 years
Secondary outcomes (3)
Blood pressure
Systolic and diastolic blood pressure in mmHg.
Measured: 2 years
Body mass index
Body mass index in kg/m2 will be calculated using height and weight
Measured: 2 years
Pulse wave velocity
Pulse wave velocity in m/s from the carotid to the femoral artery will be measured.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study startJun 2015
- Primary completionJul 2022
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21,442 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05510375
- Sponsor's protocol ID
- 1687423
- Status last verified
- Aug 2022
- First submitted
- 15 Sep 2021
- Last updated
- 22 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Randomized Cocoa Supplementation on Inflammaging and Epigenetic Aging
- ClinicalTrials.gov ID
- NCT05510375
- Acronym / sponsor ID
- 1687423
- Conditions
- Aging, Inflammation, Cardiovascular Diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21,442 participants (actual)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Study start
- Jun 2015 (actual)
- Primary completion
- Jul 2022 (actual)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 22 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cocoa extract + multivitamin | Active comparator | Dietary Supplement: Cocoa extract, Dietary Supplement: MultivitaminTwo capsules/day for 600 mg/day of cocoa flavanols One tablet/day of multivitamin |
| Cocoa extract + multivitamin placebo | Active comparator | Dietary Supplement: Cocoa extract, Dietary Supplement: Multivitamin placeboTwo capsules/day for 600 mg/day of cocoa flavanols Multivitamin placebo |
| Cocoa extract placebo + multivitamin | Active comparator | Dietary Supplement: Multivitamin, Dietary Supplement: Cocoa extract placeboCocoa extract placebo One tablet/day of multivitamin |
| Cocoa extract placebo + multivitamin placebo | Placebo comparator | Dietary Supplement: Cocoa extract placebo, Dietary Supplement: Multivitamin placeboCocoa extract placebo Multivitamin placebo |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Did not collect blood samples at baseline, Year 1, or Year 2 of follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cocoa extract2 capsules each day containing a total of 500 mg cocoa flavanols, including 80 mg (-)-epicatechin, and 50 mg theobromine | Dietary supplement | Cocoa extract + multivitamin, Cocoa extract + multivitamin placebo |
| MultivitaminMultivitamin | Dietary supplement | Cocoa extract + multivitamin, Cocoa extract placebo + multivitamin |
| Cocoa extract placeboCocoa extract placebo | Dietary supplement | Cocoa extract placebo + multivitamin, Cocoa extract placebo + multivitamin placebo |
| Multivitamin placeboMultivitamin placebo | Dietary supplement | Cocoa extract + multivitamin placebo, Cocoa extract placebo + multivitamin placebo |
Primary outcome
Epigenetic age acceleration
Time frame: 2 years
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
Time frame: 2 years
An index constructed using several inflammation markers reflecting inflammaging.
3 secondary outcomes
Blood pressure
Time frame: 2 years
Body mass index
Time frame: 2 years
Pulse wave velocity
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cocoa extract and Multivitamin in people with Aging and Inflammation, run by Augusta University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epigenetic age acceleration (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2022.