Clinical trial NCT03429920: Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors
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
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factor
Heart Diseases
Inflammation
Keywords: Fermented Soy
Cardiovascular Disease
Inflammation
DNA Methylation
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2018-02-12
Enrollment: 28
Sex: ALL
Minimum age (years): 29
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: To test the effects of Q CAN PLUS powder, on serum lipids
timeFrame: baseline to 7 months
measure: Inflammatory parameter
timeFrame: baseline to 7 months
Secondary outcomes:
measure: Fasting Glucose
timeFrame: baseline to 7 months
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
Study officials:
affiliation: Loma Linda University
name: Joan Sabate, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
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.