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

Primary Purpose

Cardiovascular Risk Factor, Heart Diseases, Inflammation

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Q CAN PLUS

Placebo

About this trial

This is an interventional prevention trial for Cardiovascular Risk Factor focused on measuring Fermented Soy, Cardiovascular Disease, Inflammation, DNA Methylation

Eligibility Criteria

29 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Loma Linda University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Q CAN PLUS POWDER

placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT03429920

First Posted

January 30, 2018

Last Updated

February 2, 2021

Sponsor

Loma Linda University

1. Study Identification

Unique Protocol Identification Number

NCT03429920

Brief Title

Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors

Acronym

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

September 23, 2018 (Actual)

Primary Completion Date

August 1, 2019 (Actual)

Study Completion Date

August 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Loma Linda University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiovascular Risk Factor, Heart Diseases, Inflammation

Keywords

Fermented Soy, Cardiovascular Disease, Inflammation, DNA Methylation

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

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.

Masking

ParticipantInvestigator

Masking Description

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.

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Q CAN PLUS POWDER

Arm Type

Experimental

Arm Description

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

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Q CAN PLUS

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

To test the effects of Q CAN PLUS powder, on serum lipids

Description

Time Frame

baseline to 7 months

Title

Inflammatory parameter

Description

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

Time Frame

baseline to 7 months

Secondary Outcome Measure Information:

Title

Fasting Glucose

Description

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

Time Frame

baseline to 7 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

29 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joan Sabate, DrPH

Organizational Affiliation

Loma Linda University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Loma Linda University

City

Loma Linda

State/Province

California

ZIP/Postal Code

92350

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33562090

Citation

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.

Results Reference

derived

Learn more about this trial

Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors

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