Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors (FS)

Loma Linda University (LLU)

Status: Completed

Conditions: Inflammation; Heart Diseases; Cardiovascular Risk Factor

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Q CAN PLUS

Study type: Interventional

Funder types: Other

Identifiers

NCT03429920

5180083

Details and patient eligibility

About

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

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 29 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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28 participants in 2 patient groups, including a placebo group

Q CAN PLUS POWDER

Experimental group

Description:

QCAN PLUS POWDER:2 pouches per day, each pouch contains(12-15gms of fermented soy powder)

Treatment:

Dietary Supplement: Q CAN PLUS

placebo

Placebo Comparator group

Description:

Sprouted brown rice protein with flavor (provided by BESO Biological Research Inc.)

Treatment:

Dietary Supplement: Placebo