ClinicalTrials.gg
CompletedNCT03429920FSUpdated Feb 4, 2021

Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors

An interventional study of Q CAN PLUS and Placebo in Cardiovascular Risk Factor, Heart Diseases and Inflammation, sponsored by Loma Linda University. Completed at 1 site in United States. Open to participants aged 29 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-02-04.

Sponsored by Loma Linda University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
29 Years to 75 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Cardiovascular Risk Factor
  • Heart Diseases
  • Inflammation

Keywords

  • Fermented Soy
  • Cardiovascular Disease
  • Inflammation
  • DNA Methylation
03

In context

Heart Diseases

2,135 studies on the registry are indexed under Heart Diseases; 252 are open to participants now.

This study's enrollment of 28 is below the median of 129 across 931 interventional studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

Loma Linda University is the lead sponsor of 306 studies on the registry; 46 are open to participants now.

Of its 29 completed or terminated interventional studies of FDA-regulated products, 23 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
29 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 ( ≥ 25 kg/m2)
  • Family history of premature heart disease

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
28 participants (actual)

Study arms

  • 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

  • Placebo comparator
    placebo

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

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementQ CAN PLUS

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

  • Dietary supplementPlacebo

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: baseline to 7 months

  2. 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

    Time frame: baseline to 7 months

Secondary outcomes

  1. 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

    Time frame: baseline to 7 months

07

Study locations

1 site
  • Loma Linda University
    Loma Linda, California 92350, United States
08

References and documents

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. PubMed 33562090 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03429920
Responsible party
Joan Sabate,DrPH, MD (Professor of Nutrition, Loma Linda University) — Principal investigator
First posted
Feb 12, 2018
Start date
Sep 23, 2018
Primary completion
Aug 1, 2019
Completion
Aug 1, 2019
Last update
Feb 4, 2021

Study contacts

Joan Sabate, DrPH
principal investigator · Loma Linda University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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