Evaluation of the effects of a new fermented milk product (Gaio) on primary hypercholesterolemia

Objective: To verify the effects on the lipid profile of a product of fermented milk (Gaio(R)) in patients with mild to moderate primary hypercholesterolemia. Design: The study was prospective, randomized, double-blinded and placebo controlled, with a crossover design. Subjects: Thirty-two patients (21 women and 11 men) with ages ranging between 36 and 65 years old were included in the study. All of them were on a controlled diet for at least 8 weeks. Intervention: Patients began, after clinical and laboratory analysis, in a randomized and double-blind manner to take 200 g daily of Gaio(R) or its placebo. After 8 weeks blood was collected again for lipid profile evaluation and the crossover was made. After an additional 8 weeks blood was collected for another lipid profile determination Results: All patients included completed the study. Comparisons were made between means of lipid profile constituents after the placebo and active product periods. These showed significant mean reduction of 5.3% (P = 0.004) for total cholesterol, 6.15% (P = 0.012) for LDL-cholesterol and no significant variation for HDL-cholesterol and triglycerides. The majority of patients presented no variation or had a decrease in their total cholesterol level. However, during the active product period, three patients showed an increase in cholesterol level by more than 5%. Conclusion: The fermented milk (Gaio(R)) produced a small but statistically significant decrease in total and LDL-cholesterol mean. However, not all subjects seem to respond to the product, and a few subjects showed a cholesterol increment. Further investigations are necessary to clarify this aspect. Sponsorship: Vigor Company, Brazil sponsored the study.