Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-23

Study Completion Date

2019-08-01

Brief Summary

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

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Detailed Description

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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

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Cardiovascular Risk Factor Heart Diseases Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This dietary intervention trial is a randomized, 2x2 crossover 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 Q CAN powder or placebo powder for 12 weeks. Following a two week wash out period, subjects will be switched over to the alternate treatment.

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Both the participants and the investigators will not be aware of which powder is the active powder and which one is the placebo. Only the Principle Investigator will be made aware.

Study Groups

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Q CAN PLUS POWDER

QCAN PLUS POWDER:2 pouches per day, each pouch contains(12-15gms of fermented soy powder)

Group Type EXPERIMENTAL

Q CAN PLUS

Intervention Type DIETARY_SUPPLEMENT

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.)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Sprouted brown rice protein with flavor (provided by BESO Biological Research, Inc.)

Interventions

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Q CAN PLUS

Active powder with fermented soy , 2 pouches per day, each pouch contains 12-15 gms of fermented soy

Intervention Type DIETARY_SUPPLEMENT

Placebo

Sprouted brown rice protein with flavor (provided by BESO Biological Research, Inc.)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

29 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No