Dietary recommendations for the treatment of hypercholesterolemia (HC) emphasize stepwise reductions in fat intake, but there is no agreement on what lower limit is desirable or achievable. These recommendations have applied broadly to persons with HC alone, as well as to those with a combined elevation in triglyceride (TG) and cholesterol, even though they may differ in pathophysiological mechanisms and response. In this paper, we describe the design and feasibility of recruiting and randomizing subjects with HC or combined hyperlipidemia (CHL) to an outpatient dietary intervention study of progressively fat-restricted diets. Diets were designed to contain 30, 26, 22, and 18% of calories from fat; 300, 200, 100, and 100 mg cholesterol/day; and a polyunsaturated/saturated fat ratio of approximately 1.0. Triglyceride and low-density-lipoprotein cholesterol (LDL-C) cutpoints were based on the age-specific 75th percentile value. Over 18 months, 8372 men were screened, yielding 320 HC subjects randomized to the four diets and 211 CHL subjects randomized to the first three diets (because of fewer CHL subjects). At baseline, HC and CHL subjects were similar in age, education, lifestyle, dietary intake, and LDL-C, but CHL subjects were heavier, more hyperglycemic, hyperinsulinemic, and hypertensive.
Conclusions: Recruiting a large cohort of HC and CHL subjects from an industrial workforce is feasible in a restricted time frame. CHL subjects demonstrate features of the insulin resistance/hypertension syndrome, differing from HC subjects. CHL is sufficiently common relative to HC (2:3) to permit a comparison of dietary responses between the two conditions. Finally, the randomization of HC and CHL subjects to the diets yielded statistically indistinguishable groups, permitting a test of the efficacy of the alternative diets within each hyperlipidemic (HL) category.