Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors

Not Applicable

Completed

• Conditions: Heart Diseases; Cardiovascular Risk Factor; Inflammation

• Registration Number: NCT03429920
• Lead Sponsor: Loma Linda University

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.

Study Timeline

• Study First Submitted: 2018-01-30
• Study First Submitted QC: 2018-02-09
• Study First Posted: 2018-02-12
• Study Start: 2018-09-23
• Primary Completion: 2019-08-01
• Study Completion: 2019-08-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-02
• Last Update Posted: 2021-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Loma Linda University; 🇺🇸 Loma Linda, California, United States