Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors

The purpose of this research study is to investigate the effects of a dietary supplement from
soybeans that might help in managing heart disease. The rationale for this study is to reduce
the risk factors of heart disease in high risk individuals by using soy supplements. The
dietary supplement intervention trial is a randomized, 2x2 cross over design with 24 subjects
in free-living conditions. There will be a two week run-in (acclimation period) after which
subjects will be randomized to receive either QCAN powder or placebo powder for 12 weeks.
Following a two week wash out period, subjects will be switched over(cross over) to alternate
treatment. Thus, the interventions of the study will last for a total of 28 weeks.

Inclusion Criteria:

- Men and women 35-75 years of age

- At high risk for cardiovascular disease, i.e. with 2 or more risk factors:

- Present tobacco smoker

- Arterial hypertension (BP ≥ 140/90 mm Hg or treatment)

- LDL-cholesterol ≥ 110 mg/dl

- HDL-cholesterol ≤ 40 mg/dl

- Triglycerides ≥ 150 mg/dl

- Fasting blood glucose ≥ 110 mg/dl

- Overweight or obesity (BMI ≥ 25 kg/m2)

- Family history of premature heart disease

Exclusion Criteria:

- Uncontrolled renal, hepatic, or endocrine disease

- Abnormal blood chemistry profile

- Familial hypercholesterolemia or other genetic dyslipidemia

- Intake of lipid-lowering drugs and dietary products including plant sterols/stanols

- High Framingham risk or medical condition in which statin therapy is considered
necessary by a treating physician

- Hypersensitive or allergic to soy or cellulose

- Alcohol or drug addiction or abuse

- Diabetes

- Lack of ability or interest to follow the dietary intervention