NCT03429920

Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Loma Linda University · Academic / Other
• Sex: All
• Age: 29 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiovascular Risk Factor
• Heart Diseases
• Inflammation

Interventions

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

Timeline

• Start date: 2018-09-23
• Primary completion: 2019-08-01
• Completion: 2019-08-01
• First posted: 2018-02-12
• Last updated: 2021-02-04

Locations

1 site across 1 country: United States