Cardiovascular Risk FactorFSNCT03429920
Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors
A study testing Q CAN PLUS in people with Cardiovascular Risk Factor and Heart Diseases, run by Loma Linda University at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 29 to 75 years
- Conditions the study is for
- Cardiovascular Risk Factor, Heart Diseases, Inflammation
- What is being tested?
- Q CAN PLUS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2018to 1 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 29 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- Triglycerides ≥ 150 mg/dl
- Fasting blood glucose ≥ 110 mg/dl
- Overweight or obesity (BMI ≥ 25 kg/m2)
- Family history of premature heart disease
Who cannot join
- 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
Show all 9Show fewer
- Alcohol or drug addiction or abuse
- Diabetes
- Lack of ability or interest to follow the dietary intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Fermented Soy Based Dietary Food Product on Cardiometabolic Risk Factors in Individuals at High Risk of Cardiovascular Disease
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.
- Conditions
- Cardiovascular Risk Factor, Heart Diseases, Inflammation
- Being tested
- Q CAN PLUS, Placebo
- Keywords
- Fermented Soy, Cardiovascular Disease, Inflammation, DNA Methylation
- Medical subject headings
- Heart Diseases, Inflammation, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Q CAN PLUSDietary supplement
Active powder with fermented soy , 2 pouches per day, each pouch contains 12-15 gms of fermented soy
PlaceboDietary supplement
Sprouted brown rice protein with flavor (provided by BESO Biological Research, Inc.)
| Study group | Role | What they receive |
|---|---|---|
| Q CAN PLUS POWDER | Experimental | QCAN PLUS POWDER:2 pouches per day, each pouch contains(12-15gms of fermented soy powder) Receives: Dietary Supplement: Q CAN PLUS |
| placebo | Placebo comparator | Sprouted brown rice protein with flavor (provided by BESO Biological Research Inc.) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: baseline to 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start23 Sep 2018
- Primary completion1 Aug 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Risk FactorStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joan Sabate,DrPH, MD, Loma Linda University
- Investigators
- Joan Sabate, DrPH, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03429920
- Sponsor's protocol ID
- 5180083
- Acronym
- FS
- Status last verified
- Feb 2021
- First submitted
- 30 Jan 2018
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Fermented Soy Based Dietary Food Product on Cardiometabolic Risk Factors in Individuals at High Risk of Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT03429920
- Acronym / sponsor ID
- FS / 5180083
- Conditions
- Cardiovascular Risk Factor, Heart Diseases, Inflammation
- Keywords
- Fermented Soy, Cardiovascular Disease, Inflammation, DNA Methylation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 23 Sep 2018 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 12 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Q CAN PLUS POWDER | Experimental | Dietary Supplement: Q CAN PLUSQCAN PLUS POWDER:2 pouches per day, each pouch contains(12-15gms of fermented soy powder) |
| placebo | Placebo comparator | Dietary Supplement: PlaceboSprouted brown rice protein with flavor (provided by BESO Biological Research Inc.) |
Who may qualify
- Ages
- 29 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Q CAN PLUSActive powder with fermented soy , 2 pouches per day, each pouch contains 12-15 gms of fermented soy | Dietary supplement | Q CAN PLUS POWDER |
| PlaceboSprouted brown rice protein with flavor (provided by BESO Biological Research, Inc.) | Dietary supplement | placebo |
Primary outcome
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.
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
1 secondary outcome
Fasting Glucose
Time frame: baseline to 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Derived from this study: PubMed 33562090Jung 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joan Sabate, DrPH principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Q CAN PLUS in people with Cardiovascular Risk Factor and Heart Diseases, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To test the effects of Q CAN PLUS powder, on serum lipids (time frame: baseline to 7 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03429920, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.