A Human Trial to Assess the Low Density Lipoprotein Cholesterol (LDL-C) Lowering Effect of Soy

Inclusion Criteria:

• Males and females (not pregnant or lactating) aged 30-70 year

• Body mass index (BMI) ≤40kg/m² and ≥18.5kg/m²

• Fasting plasma total cholesterol ≥5.0

• Fasting plasma LDL cholesterol ≥3.0 and <5.0 mmol/L.

Exclusion Criteria:

• Fasting plasma triglycerides ≥4.0 mmol/L

• Abnormal liver and kidney function

• Unstable body weight(>3kg change in 3 months) or intention to lose or gain weight;

• Diabetes mellitus (fasting plasma glucose ≥7.0 mmol/L or use of insulin or anyhypoglycemic or anti-hyperglycemic medication);

• Use of any prescription or non-prescription drug, prebiotics or probiotics, herbal ornutritional supplement known to affect blood lipids, except for stable doses (nochange in 3 months) of thyroxine, oral contraceptive agents, hormone replacementtherapy, and medications for controlling blood pressure);

• Major surgical or medical events within the past 3 months;

• Presence of a gastrointestinal disorder or medication that alters the digestion andabsorption of nutrients; including antibiotic use within the past 6 weeks.

• Consumption of a diet containing ≥15% of energy from saturated fat;

• Any food allergy or aversion or unwillingness to eat wheat, soy or milk;

• Consumption of ≥5 servings per week of soy based food products;

• Consumption of an average of >2 alcoholic beverages per day;

• Regular smokers (smoking ≥1 cigarette per day) of cigarettes or cigars