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

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ClinicalTrials.gov Identifier: NCT03429920
Recruitment Status : Recruiting
First Posted : February 12, 2018
Last Update Posted : October 29, 2018
Sponsor:
Information provided by (Responsible Party):
Joan Sabate,DrPH, MD, Loma Linda University

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

Condition or disease Intervention/treatment Phase
Cardiovascular Risk Factor Heart Diseases Inflammation Dietary Supplement: Q CAN PLUS Dietary Supplement: Placebo Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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.
Masking: Double (Participant, Investigator)
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.
Primary Purpose: Prevention
Official Title: The Effect of Fermented Soy Based Dietary Food Product on Cardiometabolic Risk Factors in Individuals at High Risk of Cardiovascular Disease
Actual Study Start Date : September 23, 2018
Estimated Primary Completion Date : March 24, 2019
Estimated Study Completion Date : March 31, 2020

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

Placebo Comparator: placebo
Sprouted brown rice protein with flavor (provided by BESO Biological Research Inc.)
Dietary Supplement: Placebo
Sprouted brown rice protein with flavor (provided by BESO Biological Research, Inc.)




Primary Outcome Measures :
  1. To test the effects of Q CAN PLUS powder, on serum lipids [ Time Frame: baseline to 7 months ]
    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.

  2. Inflammatory parameter [ Time Frame: baseline to 7 months ]
    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 :
  1. Fasting Glucose [ Time Frame: baseline to 7 months ]
    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



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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women 35-75 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03429920


Contacts
Contact: Amandeep Kaur, MPH 909-558-4300 ext 47169 akaur1@llu.edu
Contact: Ella Haddad, DrPH 909-558-4300 ext 47150 ehaddad@llu.edu

Locations
United States, California
Loma Linda University Recruiting
Loma Linda, California, United States, 92350
Contact: Amandeep Kaur, MPH    909-558-4300 ext 47169    akaur1@llu.edu   
Contact: Ella Haddad, DrPH    909-558-4300 ext 47150    ehaddad@llu.edu   
Principal Investigator: Joan Sabate, DrPH         
Sub-Investigator: Ella Haddad, DrPH         
Sponsors and Collaborators
Loma Linda University
Investigators
Principal Investigator: Joan Sabate, DrPH Loma Linda University

Responsible Party: Joan Sabate,DrPH, MD, Professor of Nutrition, Loma Linda University
ClinicalTrials.gov Identifier: NCT03429920     History of Changes
Other Study ID Numbers: 2160353
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Joan Sabate,DrPH, MD, Loma Linda University:
Fermented Soy
Cardiovascular Disease
Inflammation
DNA Methylation

Additional relevant MeSH terms:
Inflammation
Cardiovascular Diseases
Heart Diseases
Pathologic Processes