Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors

Study Overview
=================
Brief Summary
-----------------
This research study will test the effects of Q CAN PLUS powder on serum lipids, selected inflammatory and oxidative parameters and genome-wide methylation

Detailed Description
-----------------
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.

Official Title
-----------------
The Effect of Fermented Soy Based Dietary Food Product on Cardiometabolic Risk Factors in Individuals at High Risk of Cardiovascular Disease

Conditions
-----------------
Heart Diseases, Cardiovascular Risk Factor, Inflammation

Intervention / Treatment
-----------------
* Dietary Supplement: Q CAN PLUS
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women 29-75 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

Ages Eligible for Study
-----------------
Minimum Age: 29 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This dietary intervention trial is a randomized, 2x2 crossover 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 Q CAN powder or placebo powder for 12 weeks. Following a two week wash out period, subjects will be switched over to the alternate treatment.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Q CAN PLUS POWDER<br>QCAN PLUS POWDER:2 pouches per day, each pouch contains(12-15gms of fermented soy powder) | Dietary Supplement: Q CAN PLUS<br>* Active powder with fermented soy , 2 pouches per day, each pouch contains 12-15 gms of fermented soy<br>|
| Placebo Comparator: placebo<br>Sprouted brown rice protein with flavor (provided by BESO Biological Research Inc.) | Dietary Supplement: Placebo<br>* Sprouted brown rice protein with flavor (provided by BESO Biological Research, Inc.)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To test the effects of Q CAN PLUS powder, on serum lipids | This is a composite measurement which will measure the change in the levels of serum Low Density Cholesterol, High Density Cholesterol, ApoLipoprotein A and B, APO E Allele genetic typing and triglycerides before the ingestion of QCAN PLUS powder and at 7 months after ingestion of Q CAN PLUS powder. | baseline to 7 months | 
| Inflammatory parameter | to test the changes in concentration of hs-CRP (highly sensitive C reactive protein) in the blood prior to ingestion of Q CAN PLUS powder and again at 7 months after ingestion of Q CAN PLUS Powder | baseline to 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting Glucose | to test the changes in the concentration of fasting glucose levels in the blood prior to ingestion of Q CAN PLUS powder and again after 7 months after ingestion of QCAN PLUS powder | baseline to 7 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fermented Soy, Cardiovascular Disease, Inflammation, DNA Methylation