Effects of Soy Based Dietary Supplements on Cardiometabolic Risk Factors.

Study Overview
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Brief Summary
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This study will test the effect of both Luna Rich X© and Reliv Now© against placebo pills or powder (control) on blood lipids. It will also explore the potential effects of these dietary supplements on inflammation markers and other biological and anthropometric measures. The study intervention will be 30 weeks in length. Twenty four subjects with 2 or more cardiometabolic risk factors will be randomized to participate in the study.

Detailed Description
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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 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. 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.)

Official Title
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The Effect of Soy-based Dietary Supplements on Cardiometabolic Risk Factors in Individuals at High Risk for Cardiovascular Disease

Conditions
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Obesity, Cardiovascular Risk Factors

Intervention / Treatment
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* Dietary Supplement: Luna Rich X
* Dietary Supplement: Placebo
* Dietary Supplement: Reliv Now


Participation Criteria
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Eligibility Criteria
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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: Uncontrolled renal/hepatic/endocrine disease Abnormal blood chemistry profile Familial hypercholesterolemia or other genetic dyslipidaemia 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 Alcohol or drug addiction/abuse Diabetics Impossibility or lack of interest to follow the dietary intervention

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Luna Rich X<br>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 | Dietary Supplement: Luna Rich X<br> <br> |
| Experimental: Reliv Now<br>19 grams of power/day, that subjects will mix and consume daily with water or a beverage they commonly drink | Dietary Supplement: Reliv Now<br> <br> |
| Placebo Comparator: Placebo<br>Placebo pills containing starch (provided by Reliv International, Inc.) | Dietary Supplement: Placebo<br>* Starch pill/or powder manufactured to mimic Luna Rich X and Reliv Now<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Lipid profile | Serum Low density cholesterol, high density cholesterol, apo Lipoprotein A and B, apo E allele genetic typing and triglycerides will be measured from the by performing lab tests. | baseline- 30 weeks | 
| Inflammatory and oxidative parameters | hs-CRP (highly sensitive C-reactive protein), TNF-alpha (tissue necrosis factor alpha), IL-6 (Interleukin 6), ox-LDL (oxidized low density lipoprotein), TBARS (thiobarbituric acid reactive substances) lipid peroxides, 8-OHdG (8-hydroxy-2-deoxyguanosine) will be measured via lab tests | baseline- 30 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hormones | : adiponectin, leptin, insulin, C-peptide (C-peptide of insulin); and fasting glucose and hemoglobin A1c. will be measured via lab tests | baseline- 30 weeks | 
| Compliance | , blood samples will be taken for testing levels of lunasin and/or its metabolites as biological marker(s) of the treatment compliance. | baseline -30 weeks |