Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors

NCT03429920 | Completed

• 1 other identifier: 5180083
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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

Conditions

Cardiovascular Risk Factor; Heart Diseases; Inflammation

Keywords

Fermented Soy; Cardiovascular Disease; Inflammation; DNA Methylation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Fasting Glucose

  baseline to 7 months

Study Arms (2)

Q CAN PLUS POWDER

EXPERIMENTAL

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

Dietary Supplement: Q CAN PLUS

placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Q CAN PLUS DIETARY_SUPPLEMENT

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

Q CAN PLUS POWDER

Placebo DIETARY_SUPPLEMENT

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

placebo

Eligibility Criteria

• Age: 29 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University

Loma Linda, California, 92350, United States

Location

Related Publications (1)

• 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.

  PMID: 33562090 DERIVED

MeSH Terms

Conditions

Heart Diseases; Inflammation; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Joan Sabate, DrPH

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Nutrition

Model Details: 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.

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: February 12, 2018
• Study Start: September 23, 2018
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: February 4, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)