Studying if supplements help heart health
Cardiovascular disease is the leading cause of death in the United States, accounting for about one-third of all deaths. Nearly 20 percent of men ages 60 to 79 have cardiovascular disease, while almost 10 percent of women do. Those numbers jump to 32 percent of men and nearly 19 percent of women at age 80 and older.
Doctors think that natural compounds found in fruits and vegetables, called flavonoids, may protect against heart disease and improve blood flow to the heart. Also, omega-3 fats, found in fish and mussels, have been shown to protect the heart.
Researchers at the National Institutes of Health in Bethesda, Md., want to know if supplements containing blackcurrant extract (for flavonoids) and omega-3 fats can improve blood flow to the heart. They also want to learn about the health of blood vessels, and how the heart works while taking these supplements.
Studying adults 55+
They are now enrolling healthy adults age 55 to 75 in a study to see whether and how these supplements can improve heart health.
To be eligible, volunteers must have normal blood pressure or be pre-hypertensive with blood pressure up to 139/89. Similarly, their cholesterol levels must be normal or mildly elevated, up to 239 for total cholesterol, LDL up to 159, HDL up to 40, and triglycerides no higher than 199. Their BMI must be in the normal range, between 18.5 and 25.
Their C-reactive protein (CRP) level, a measure of inflammation in the body, must be less than 3, and their fasting blood glucose level must be greater than 120.
Those in the study cannot have any progressive or unstable disease, including cardiovascular, pulmonary, gastrointestinal, central nervous system, psychiatric, endocrine, hematologic, renal or immunologic disorders. They cannot smoke or have more than one to two alcoholic drinks per day.
Supplements off and on
During the first study visit, participants will be screened with a medical history, physical exam and blood tests. A small device will be placed on their arm to take pictures of blood vessels. A blood pressure cuff will be tightened on their arm and more pictures will be taken. The visit will take six or seven hours.
After that, participants will make four visits to NIH eight weeks apart. Those in the study will be divided into two groups. One group will take blackcurrant and omega-3 tablets for eight weeks, while the other will take a placebo — tablets with no active ingredients in them.
Participants will then switch the type of tablets they were taking and take the other type for eight weeks. The whole process will then repeat, for a total of 32 weeks. There will also be a short time with no supplements taken to make sure they have washed out of participants’ systems before switching.
Every eight weeks, participants will have another, shorter clinic visit that will repeat most of the tests from the first visit.
All tests and study supplements are provided free or charge, but no compensation is offered for participation.
To learn more, contact the NIH Clinical Center’s Patient Recruitment and Public Liaison Office at 1-800-411-1222 or email prpl@mail.cc.nih.gov. Refer to this study by its ClinicalTrials.gov identifier: NCT02019680.