Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors

Inflammation Clinical Trial

— FS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03429920
• Other study ID #: 5180083
• Status: Completed
• Phase: N/A
• Start date: September 23, 2018
• Est. completion date: August 1, 2019

Study information

• Verified date: February 2021
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: August 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 29 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Heart Diseases
• Inflammation

Intervention

Dietary Supplement:
• Q CAN PLUS
Active powder with fermented soy , 2 pouches per day, each pouch contains 12-15 gms of fermented soy
• Placebo
Sprouted brown rice protein with flavor (provided by BESO Biological Research, Inc.)

Locations

Country	Name	City	State
United States	Loma Linda University	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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