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

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

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

Study Overview

• Status: Completed
• Conditions: Heart Diseases; Inflammation; Cardiovascular Risk Factor
• Intervention / Treatment: Dietary supplement: Q CAN PLUS; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92350
      • Loma Linda University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 29 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Q CAN PLUS POWDER; QCAN PLUS POWDER:2 pouches per day, each pouch contains(12-15gms of fermented soy powder)	Dietary supplement: Q CAN PLUS; Active powder with fermented soy , 2 pouches per day, each pouch contains 12-15 gms of fermented soy
Placebo Comparator: placebo; Sprouted brown rice protein with flavor (provided by BESO Biological Research Inc.)	Dietary supplement: Placebo; Sprouted brown rice protein with flavor (provided by BESO Biological Research, Inc.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Loma Linda University
• Investigators: Principal Investigator: Joan Sabate, DrPH, Loma Linda University

Publications and helpful links

General Publications

• Jung SM, Haddad EH, Kaur A, Sirirat R, Kim AY, Oda K, Rajaram S, Sabate J. A Non-Probiotic Fermented Soy Product Reduces Total and LDL Cholesterol: A Randomized Controlled Crossover Trial. Nutrients. 2021 Feb 6;13(2):535. doi: 10.3390/nu13020535.

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2018
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: January 30, 2018
• First Submitted That Met QC Criteria: February 9, 2018
• First Posted (Actual): February 12, 2018

Study Record Updates

• Last Update Posted (Actual): February 4, 2021
• Last Update Submitted That Met QC Criteria: February 2, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Inflammation; Cardiovascular Disease; DNA Methylation; Fermented Soy
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Heart Diseases; Inflammation
• Other Study ID Numbers: 5180083

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No