Status:
COMPLETED
Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors
Lead Sponsor:
Loma Linda University
Conditions:
Cardiovascular Risk Factor
Heart Diseases
Eligibility:
All Genders
29-75 years
Phase:
NA
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 fac...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2019
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03429920
Start Date
September 23 2018
End Date
August 1 2019
Last Update
February 4 2021
Active Locations (1)
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1
Loma Linda University
Loma Linda, California, United States, 92350