Objectives: To study possible synergistic effects of oats and soy on reducing total and low-density lipoprotein cholesterol (LDL-C) concentrations in human beings and the efficacy and feasibility of including these adjustments to a National Cholesterol Education Program Step I diet. SUBJECT/SETTING: One hundred twenty-seven postmenopausal women with moderate hypercholesterolemia were recruited from a large Midwestern workforce and senior centers in the surrounding community. Intervention and clinical visits were conducted in these same facilities.
Design: After a 3-week lead-in period on the Step I diet, participants were randomly assigned to 1 of 4 dietary treatments for an additional 6 weeks: an oats/milk group, a wheat/soy group, an oats/soy group, and a wheat/milk group. Clinical measurements included blood draws, body weight and height, blood pressure, and medical history data. Three-day food records were collected at baseline and Weeks 3 and 9 of the intervention. Randomization was stratified based on the status of hormone replacement therapy and was blocked with sizes 4 or 8 for group assignment.
Results: After 3 weeks on the Step I diet, total cholesterol, LDL-C, and triglyceride levels; total fat and saturated fat intake, dietary cholesterol intake, Keys score, and body mass index were all reduced. Following an additional 6 weeks on the Step I diet plus intervention, total cholesterol and LDL-C were further reduced for both the oats/soy group and oats/milk group. There were no significant further changes in total cholesterol, LDL-C, or high-density lipoprotein cholesterol levels in the wheat/soy and wheat/milk groups. Body mass index remained stable in all groups from Week 3 to Week 9.
Applications: Nonpharmacologic dietary interventions like the Step I diet are feasible in a community setting and can produce rapid and significant lipid-lowering benefits. Daily consumption of 2 servings of oats can contribute to further lipid alterations in this population although soy intake at this dose may not. Palatability and convenience are important considerations in achieving dietary adherence.