COcoa Supplement and Multivitamin Outcomes Study for the Mind (COSMOS-Mind)
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| ClinicalTrials.gov Identifier: NCT03035201 |
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Recruitment Status :
Completed
First Posted : January 27, 2017
Last Update Posted : September 13, 2022
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| Condition or disease |
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| Cognitive Impairment Dementia Aging |
Identifying a safe, affordable, and well-tolerated intervention that prevents cognitive decline in older adults is of critical public health importance. There is compelling evidence from basic science, and small clinical studies that cocoa flavanols may protect cognitive function in older adults and reduce risk of Alzheimer's disease (AD) and related dementia. Thus, this intervention could have important downstream benefits for health care utilization and cost, caregiver burden, and overall quality of life for older adults. Cocoa flavanol effects on cognition, however, need to be assessed in a definitive clinical trial.
The parent trial (COSMOS) will enroll 21,442 women and men nationwide, drawn from the Women's Health Initiative (WHI) participant cohort and the VITamin D and OmegA-3 TriaL (VITAL) non-randomized respondent cohort, and will be conducted primarily by mail to assess whether high-potency cocoa flavanol extract and a multivitamin - alone or in combination - will reduce risk of cardiovascular disease and cancer over 3 years of follow-up.
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 https://doi.org/10.1093/jaoacint/qsaa132 [secure-web.cisco.com]). This updated method relies on a reference material (RM8403) recently standardized and made commercially available by the U.S. 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 2020.05/RM8403 to the COSMOS intervention, the total cocoa flavanol content of the COSMOS intervention is now 500 mg/day. Reporting of (-)-epicatechin content remained unaffected. Going forward, this record will therefore apply AOAC 2020.05/RM8403 and report that the COSMOS intervention tested 500 mg/day of cocoa flavanols, including 80 mg of (-)-epicatechin.
Once participants are enrolled in COSMOS, the study team at Brigham and Women's Hospital will provide contact information and other parent trial outcomes for COSMOS-Mind participants to the Wake Forest team using a secure web-based data transfer system. This seamless exchange of information between sites will permit timely accounting to ensure that the targeted demographics for enrollment are achieved (e.g. gender, age, race, ethnicity).
COSMOS-Mind will only be administered a telephone cognitive assessment to all participants at enrollment (baseline), and annually for 3 years of follow-up by trained and certified staff of the Wake Forest COSMOS-Mind team.
| Study Type : | Observational |
| Actual Enrollment : | 2262 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | COcoa Supplement and Multivitamin Outcomes Study-Mind |
| Study Start Date : | September 2016 |
| Actual Primary Completion Date : | February 12, 2021 |
| Actual Study Completion Date : | February 12, 2021 |
| Group/Cohort |
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Cocoa extract + multivitamin
2 capsules containing 500 mg/d cocoa extract; daily MTV
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Cocoa extract + multivitamin placebo
2 capsules containing 500 mg/d cocoa extract; daily MTV placebo
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Cocoa extract placebo + multivitamin
Cocoa extract placebo (2 capsules/d); daily MTV
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Cocoa extract placebo + multivitamin placebo
Cocoa extract placebo (2 capsules/d); daily MTV placebo
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- Number of Participants that are not Hearing Impaired [ Time Frame: 4 years ]The number of participants that are not hearing impaired and can be administered the cognitive assessments will be recorded.
- Cocoa extract effects on global cognitive trajectory [ Time Frame: 4 years ]
A composite cognitive measure that combines individual test scores of global cognitive function (TICSm), memory (SR), and executive function (OTMT, Verbal Fluency, Number Span Test, DOT), which will be compared across participants randomized to received daily cocoa extract (with and without co-administration of the the multivitamin) versus placebo (with and without co-administration of the multivitamin).
[Time Frame: Total of 4 years: Baseline + 3 Years of follow-up]
- Multivitamin effects on global cognitive trajectory [ Time Frame: 4 years ]
A composite cognitive measure that combines individual test scores of global cognitive function (TICSm), memory (SR), and executive function (OTMT, Verbal Fluency, Number Span Test, DOT), which will be compared across participants randomized to received daily cocoa extract (with and without co-administration of the the multivitamin) versus placebo (with and without co-administration of the multivitamin).
[Time Frame: Total of 4 years: Baseline + 3 Years of follow-up]
- Treatment effects on incident cognitive impairment [ Time Frame: 4 years ]New cases of mild cognitive impairment, Alzheimer's disease or other dementias will be compared across treatment groups
- Intervention effects on executive function and episodic memory [ Time Frame: 4 years ]
Composite cognitive measures that combine individual test scores of executive function and of episodic memory will be compared across participants randomized to received daily cocoa extract (with and without co-administration of the the multivitamin) versus placebo (with and without co-administration of the multivitamin).
[Time Frame: Total of 4 years: Baseline + 3 Years of follow-up]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 65 Years and older (Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Participants in COSMOS (NCT02422745) who meet the following criteria are eligible to participate in this ancillary study:
Inclusion Criteria -
- Men and women 65 years and older.
- Willingness to participate.
- Ability to answer questions by phone.
Exclusion Criteria -
- Participants who are co-enrolled in the WHI Memory Study.
- Participants with insulin-dependent diabetes.
- Participants who are unable to complete the baseline cognitive assessments.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035201
| United States, North Carolina | |
| Wake Forest School of Medicine | |
| Winston-Salem, North Carolina, United States, 27157 | |
| Principal Investigator: | Laura D Baker, PhD | Wake Forest University Health Sciences | |
| Principal Investigator: | Mark A Espeland, PhD | Wake Forest University Health Sciences | |
| Principal Investigator: | Stephen R Rapp, PhD | Co-Investigator Wake Forest School of Medicine | |
| Principal Investigator: | Sally A Shumaker, PhD | Co-Investigator Wake Forest School of Medicine | |
| Principal Investigator: | JoAnn E Manson, MD | Parent Study Principal Investigator/COSMOS Mind Co-Investigator Brigham and Women's Hospital | |
| Principal Investigator: | Howard Sesso, SCD, MPH | Parent Study Principal Investigator/COSMOS Mind Co-Investigator Brigham and Women's Hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Wake Forest University Health Sciences |
| ClinicalTrials.gov Identifier: | NCT03035201 |
| Other Study ID Numbers: |
IRB00037753 1R01AG050657-01A1 ( U.S. NIH Grant/Contract ) |
| First Posted: | January 27, 2017 Key Record Dates |
| Last Update Posted: | September 13, 2022 |
| Last Verified: | June 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | COSMOS-Mind and COSMOS (parent trial, PI: Manson and Sesso) have data transfer procedures and protocols in place which use password protection and encryption, to permit seamless and secure exchange of information. Safety monitoring will be completed through the parent trial. The COSMOS-Mind staff will send all adverse events reported to them to the parent trial for reporting and follow-up. This data will be sent electronically only to approved users through a protected network. |
| Supporting Materials: |
Study Protocol Informed Consent Form (ICF) |
| Time Frame: | after completion of study |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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Memory Mild Cognitive Impairment Alzheimer's Disease Cognition |
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Cognitive Dysfunction Neurocognitive Disorders Mental Disorders Cognition Disorders |