Effects of Soy Based Dietary Supplements on Cardiometabolic Risk Factors.

Primary Objective To test the effects of Luna Rich X©, and Reliv Now© on serum lipids and
selected inflammatory and oxidative parameters.

Secondary Objective To explore the potential effects of Luna Rich X© and Reliv Now© on body
weight and adiposity.

Hypotheses

1. Eight-week supplementation of formulated lunasin-enriched soy concentrate (Luna Rich
X©) in adults at risk for cardiovascular disease will improve their serum lipid profile
and reduce inflammatory parameters.

2. Eight-week supplementation of a formulated soy-based powder (Reliv Now) plus Luna Rich
X in adults at risk for cardiovascular disease will improve their serum lipid profile
and reduce inflammatory parameters.

Study Protocol

Recruitment of Subjects Subjects will be recruited from out-patient clinics in or near Loma
Linda University. In collaboration with the medical personnel of the Family and Internal
Medicine clinics of the Loma Linda University and Beaver Medical Group, interested
clients/patients will be referred to the study. Potential subjects will be informed about
the study by the physician, nurse or other clinic personnel and will be given a flyer.
Individuals will make their own decision whether or not to participate in the study. The
clients/patients who will be interested in participating in the study will contact the
investigators via the provided phone numbers. A dedicated telephone line and webpage will
provide both additional information to interested individuals and a means to screen out
subjects by the study personnel. Potential subjects will first be screened by study
personnel, and then directed to a clinical laboratory at Loma Linda University for
determination of biochemical parameters on which the eligibility for the study will be
determined.

Dietary Interventions

- Luna Rich X©: 500 mg/ day in 4 pills of lunasin-enriched soy protein concentrate

- Reliv Now: 19 grams of powder/day, that subject will mix and consume daily with water
or a beverage they commonly drink.

- Control: Placebo pills containing starch (provided by Reliv International, Inc.)

Inclusion Criteria:

1. 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 ≥130 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:

1. Uncontrolled renal/hepatic/endocrine disease

2. Abnormal blood chemistry profile

3. Familial hypercholesterolemia or other genetic dyslipidaemia

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

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

6. Hypersensitive or allergic to soy

7. Alcohol or drug addiction/abuse

8. Diabetics

9. Impossibility or lack of interest to follow the dietary intervention