Cardiovascular Risk Factor, Heart Diseases, Inflammation
Conditions
Keywords
Fermented Soy, Cardiovascular Disease, Inflammation, DNA Methylation
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.
Interventions
DIETARY_SUPPLEMENTQ CAN PLUS
Active powder with fermented soy , 2 pouches per day, each pouch contains 12-15 gms of fermented soy
DIETARY_SUPPLEMENTPlacebo
Sprouted brown rice protein with flavor (provided by BESO Biological Research, Inc.)
Sponsors
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
Both the participants and the investigators will not be aware of which powder is the active powder and which one is the placebo. Only the Principle Investigator will be made aware.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
29 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To test the effects of Q CAN PLUS powder, on serum lipids | baseline to 7 months | 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. |
| Inflammatory parameter | baseline to 7 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fasting Glucose | baseline to 7 months | 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 |
Countries
United States
Outcome results
None listed