• Trial testing cocoa flavanol supplement

    From ScienceDaily@1:317/3 to All on Wed Mar 16 22:30:42 2022
    Trial testing cocoa flavanol supplement shows promise for reducing cardiovascular risk

    Date:
    March 16, 2022
    Source:
    Brigham and Women's Hospital
    Summary:
    The first large-scale trial to test the long-term effects of a
    cocoa flavanol supplement to prevent cardiovascular disease offers
    promising signals that cocoa flavanols could have protective
    cardiovascular effects.



    FULL STORY ==========================================================================
    The first large-scale trial to test the long-term effects of a cocoa
    flavanol supplement to prevent cardiovascular disease offers promising
    signals that cocoa flavanols could have protective cardiovascular
    effects. In papers published in The American Journal of Clinical
    Nutrition, a team led by Howard Sesso, ScD, MPH, and JoAnn Manson,
    MD, DrPH, both of the Division of Preventive Medicine at Brigham and
    Women's Hospital, unpacks the main outcomes of the COcoa Supplement and Multivitamin Outcomes Study (COSMOS), a randomized, placebo-controlled
    trial that tested a cocoa flavanol supplement and a multivitamin in the prevention of cardiovascular disease and cancer. While neither supplement significantly reduced the primary outcome of total cardiovascular events, people randomized to receive the cocoa flavanol supplement had a 27
    percent lower rate of cardiovascular death, a pre-specified secondary
    endpoint.


    ========================================================================== "When we look at the totality of evidence for both the primary and
    secondary cardiovascular endpoints in COSMOS, we see promising signals
    that a cocoa flavanol supplement may reduce important cardiovascular
    events, including death from cardiovascular disease," said Sesso. "These findings merit further investigation to better understand the effects
    of cocoa flavanols on cardiovascular health." "Previous studies have
    suggested health benefits of flavanols -- compounds in several plant-based foods including cocoa, tea, grapes, and berries," said Manson. "COSMOS
    was not a chocolate trial -- rather, it's a rigorous trial of a cocoa
    extract supplement that contains levels of cocoa flavanols that a person
    could never realistically consume from chocolate without adding excessive calories, fat, and sugar to their diet." Smaller, short-term trials have
    found cardiovascular benefits for cocoa flavanols on blood pressure and
    blood vessel dilation. COSMOS offered the first opportunity to study if
    a cocoa flavanol supplement might also lead to longer- term reductions in clinical cardiovascular events. Investigators also looked for reductions
    in risk of cancer. In addition, the trial was designed to test a common multivitamin in the prevention of cancer and cardiovascular disease.

    The primary cardiovascular outcome for the cocoa flavanol intervention
    was a composite of total cardiovascular events, including heart attacks, stroke, coronary revascularization, cardiovascular death, carotid
    artery disease, peripheral artery surgery, and unstable angina. More
    than 21,000 participants were randomized to take daily capsules that
    contained 500 mg cocoa flavanols (donated by Mars Edge), a multivitamin
    tablet (donated by GSK Consumer Healthcare), neither or both.

    The study found that cocoa flavanols reduced total cardiovascular events
    by 10 percent, but this was not statistically significant. However,
    several secondary analyses provided broader support for a potential
    benefit of cocoa flavanols on cardiovascular events. First, those
    receiving the cocoa flavanol supplement had a significant 27 percent
    reduction in death from cardiovascular disease.

    Second, when the study team took adherence to study pills into account
    (by looking at those taking their study pills regularly), the team saw
    a stronger, 15 percent reduction in total cardiovascular events and
    a 39 percent reduction in death from cardiovascular disease. Third,
    a composite endpoint of major cardiovascular events (heart attacks,
    strokes, and cardiovascular deaths), although not a trial focus, was
    also significantly reduced. The authors note in their report that their promising results on cocoa flavanols and cardiovascular events warrant
    cautious interpretation and underscore the need for additional research.

    A daily multivitamin had no significant effect on total or individual cardiovascular events. There were no safety concerns for either cocoa
    flavanols or a multivitamin.

    COSMOS concluded after about 3.6 years, which was likely too short to
    detect whether the supplements could have affected cancer risk. Although
    a daily multivitamin improved levels of several nutritional biomarkers,
    it had no significant effect on total invasive cancer, the primary outcome
    for the multivitamin analyses. Cocoa flavanols also had no significant
    effect on total invasive cancer. The authors note that continuing to
    follow COSMOS participants may help to clarify any longer-term effects
    on cancer and death. The investigators and collaborators are also
    leveraging COSMOS to study cognitive decline, falls, eye disease, and
    other aging-related outcomes that may be influenced by the supplements.

    "Although our study suggests intriguing signals for cardiovascular
    protection with cocoa flavanols, any health benefits due to taking these supplements will need confirmation in a future trial," said Manson. Adds
    Sesso: "Our message for consumers is to eat a healthy, balanced diet,
    rich in natural food sources of flavanols, and to stay tuned as we further evaluate other important health outcomes in COSMOS." Sesso and Manson
    reported receiving investigator-initiated grants from Mars Edge, a segment
    of Mars Incorporated dedicated to nutrition research and products, for infrastructure support and donation of COSMOS study pills and packaging,
    and Pfizer Consumer Healthcare (now part of GSK Consumer Healthcare) for donation of COSMOS study pills and packaging during the conduct of the
    study. Dr. Sesso additionally reported receiving investigator-initiated
    grants from Pure Encapsulations and Pfizer Inc., and honoraria and/or
    travel for lectures from the Council for Responsible Nutrition, BASF,
    NIH, and American Society of Nutrition during the conduct of the study.

    Funding:The Cocoa Supplement and Multivitamin Outcomes Study (COSMOS) is supported by an investigator-initiated grant from Mars Edge, a segment
    of Mars dedicated to nutrition research and products, which included infrastructure support and the donation of cocoa extract-containing
    study pills and packaging.

    Pfizer Consumer Healthcare (now part of GSK Consumer Healthcare) provided support through the partial provision of study pills (Centrum Silver)
    and packaging. COSMOS is also supported in part by grants AG050657,
    AG071611, EY025623, and HL157665 from the National Institutes of Health, Bethesda, MD.

    The Women's Health Initiative (WHI) program is funded by the National
    Heart, Lung, and Blood Institute, National Institutes of Health,
    U.S. Department of Health and Human Services through contracts
    75N92021D00001, 75N92021D00002, 75N92021D00003, 75N92021D00004,
    75N92021D00005. Neither company had a role in the trial design or conduct,
    data collection (other than blinded assays supported by Mars Edge and
    completed independently), data analysis, or manuscript preparation
    or review.


    ========================================================================== Story Source: Materials provided by Brigham_and_Women's_Hospital. Note:
    Content may be edited for style and length.


    ========================================================================== Journal References:
    1. Howard D Sesso et al. Effect of cocoa flavanol supplementation for
    prevention of cardiovascular disease events: The COSMOS randomized
    clinical trial. The American Journal of Clinical Nutrition, 2022;
    DOI: 10.1093/ajcn/nqac055
    2. Howard D Sesso et al. Multivitamins in the prevention of cancer and
    cardiovascular disease: The COSMOS randomized clinical
    trial. The American Journal of Clinical Nutrition, 2022; DOI:
    10.1093/ajcn/nqac056 ==========================================================================

    Link to news story: https://www.sciencedaily.com/releases/2022/03/220316173304.htm

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