HOMOCYSTEINE DIET STUDY: EFFECTS OF DIFFERENT FOLATE SOURCES

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The study objective is to determine the effect of three different sources of folic acid (folate) intake on plasma homocysteine levels in a study population with moderately elevated homocysteine levels. The three sources will be (1) a B-vitamin supplement, (2) foods fortified with folic acid, and (3) foods naturally abundant in folic acid. Participants will be assigned to one of these three groups, or a placebo group who will receive in inactive placebo. Study duration will be 12-weeks. Homocysteine levels will be measured weekly for the first 6 weeks, then at week #9 and again at end study at week #12. Therefore, we will study not only the magnitude of the change elicited by the intervention, but also the timecourse. This outpatient study will make use of the GCRC facilities for patient care related to blood sampling, aliquoting, and storing of samples. Participants will provide there own food sources of folate, according to instructions received in weekly nutrition workshops. The two groups receiving either B-vitamin supplementation or placebo will be provided with tablets for the full 12-weeks. Since the group consuming folate rich foods (not folate fortified foods) is likely to increase their intake of fiber and other potential cholesterol lowering dietary agents, we will also measure plasma cholesterol at weeks #1, #6 and #12. As a measure of compliance, we will measure plasma folate levels as well. Implications: For individuals with hyperhomocysteinemia who have been advised to increase their folate intake, this will help to determine which of several approches for increasing folate is most effective.