Cognitive ChangeISNCT04866576
Effect of a Fermented Soy Product on Cognition, Immune Status and Vaccine
A study testing Q CAN PLUS in people with Cognitive Change and Inflammation, run by Loma Linda University at 1 site in United States.
Trial summary
The research study will test the effects of Q CAN PLUS powder on the immune, inflammatory and cognitive functions. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change, Inflammation, Immune Response
- What is being tested?
- Q CAN PLUS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2021to 1 Mar 2022
- 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 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Elderly men and women, 65 years of age or older
- Ambulatory
- Able to accommodate the intervention food products
- Live in or around Loma Linda to be able to commute to the Nutrition Research Center
Who cannot join
- Intolerance to soy products
- Immune system insufficiency or disease
- Insulin dependent diabetes mellitus
- Alzheimer's disease
- Dialysis
- Current cancer radiation or chemotherapy
- Prednisone or Prednisolone Therapy greater than 10mg/d
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University School of Public Health
Loma Linda, California, 92350
About this study
Official title: Effect of a Fermented Soy Product on Cognition, Immune Status and Response to Influenza Vaccine in Elderly Men and Women
The research study will test the effects of Q CAN PLUS powder on the immune, inflammatory and cognitive functions.
Read the detailed description
The purpose of this study is to determine the effects of a fermented soy product (Q-CAN), compared to placebo, on the immune, inflammatory and cognitive functions of elderly individuals. The study intervention will be four months in length. sixty two participants , 65 years or older will be randomized to participate in the study.
- Conditions
- Cognitive Change, Inflammation, Immune Response
- Being tested
- Q CAN PLUS, Placebo
- Keywords
- Fermented Soy, Cognition, Inflammation, Immunity
- Medical subject headings
- Inflammation
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
Maltodextrin powder with Whey protein and 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 (12-15 gms 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.
Changes in immune status measurements
Immune status measurements will be performed using both static and functional tests on whole blood, serum and peripheral blood mononuclear cells (PBMC). Phlebotomy to obtain the needed samples will be performed at baseline (week 0) and at 16 weeks. Changes in immune status include changes in: (a) lymphocyte activity and cytokine production (b) natural killer cells activity, (c) lymphocyte subsets, and (d) inflammatory markers and cytokines.
Measured: baseline to week 16
Changes in lymphocyte activity and cytokine production
Lymphocyte activity and cytokine production will be measured using enzyme-linked immunoassay (ELISA) and flow cytometry. Peripheral blood mononuclear cells (PBMCs) will be incubated and stimulated with or without phytohemagglutinin (PHA) or Lipopolysaccharide (LPS) and the culture supernatant fluids collected and assayed using ELISA for the following cytokines: granulocyte macrophage colony- stimulating Factor (GM-CSF), tumor necrosis factor alpha (TNF-α), interferon gamma (IFN-γ), interleukin 1 beta (IL-1β), interleukin 2 (IL-2), interleukin 6 (IL-6), and interleukin 10 (IL-10).
Measured: baseline to week 16
Changes in lymphocyte subsets
Immunophenotyping will be performed on cryopreserved PBMCs using a flow cytometry. The following markers will be measured: T cytotoxic cells (Tc; CD3+CD8+), T helper cells (Th; CD3+CD4+), B cells (CD19+), NK cells (NK; CD3-CD16+), and regulatory T cells (Treg; CD3+CD4+CD25+Foxp3+).
Measured: baseline to week 16
Changes in inflammatory factors and cytokines
Inflammatory markers in serum will be measured by ELISA and will include C-reactive protein (CRP), E-selectin, Pentraxin 3, Rantes, MCP-1 and Eotaxin.
Immunophenotyping will be performed on cryopreserved PBMCs using a flow cytometry. The following markers will be measured: T cytotoxic cells (Tc; CD3+CD8+), T helper cells (Th; CD3+CD4+), B cells (CD19+), NK cells (NK; CD3-CD16+), and regulatory T cells (Treg; CD3+CD4+CD25+Foxp3+). Additional characterization of T cells based on naive and memory phenotypes will be determined by corresponding patterns in the expression of CD45RA, CD45RO and CD62L, while different subpopulations of Tregs will be further differentiated by expressions of GITR, CTLA-4 and LAG-3
Measured: baseline to week 16
Changes in complete blood count (CBC) and differential count
CBC and the differential counts will be performed on whole blood with the use of an automated hematology analyzer at a certified clinical facility.
Immunophenotyping will be performed on cryopreserved PBMCs using a flow cytometry. The following markers will be measured: T cytotoxic cells (Tc; CD3+CD8+), T helper cells (Th; CD3+CD4+), B cells (CD19+), NK cells (NK; CD3-CD16+), and regulatory T cells (Treg; CD3+CD4+CD25+Foxp3+). Additional characterization of T cells based on naive and memory phenotypes will be determined by corresponding patterns in the expression of CD45RA, CD45RO and CD62L, while different subpopulations of Tregs will be further differentiated by expressions of GITR, CTLA-4 and LAG-3
Measured: baseline to week 16
Secondary outcomes (2)
Changes from baseline in global cognitive composite score
The composite score will be calculated using the scores from the tests listed below. We will calculate the standardized scores of each test as the score of each participant minus the group mean and divide by its standard deviation. The composite score is the mean of the standardized scores.
The 12 tests are: Rey Auditory Verbal Learning Test (RAVLT), Rey-Osterrieth Complex Figure (ROCF), Semantic Fluency (Animals), Boston Naming Test (BNT), Visual Object and Space Perception Battery (VOSP), Block Design section from the Wechsler Adult Intelligence Scale (WAIS-III), Trail Making Test (TMT), FAS Word Fluency, Stroop Color Word Test, Symbol Digit Modalities Test (SMDT) Digit Span from the WAIS-III and Conners Continuous Performance Test (CPT-II).
Measured: baseline to week 16
Changes in the upper respiratory infection questionnaire score
Upper respiratory tract infections will be tracked using the Jackson and Dowling questionnaire as adapted and published by Martineau et al. (2015). The questionnaire will be completed daily by participants, either manually or electronically, throughout the 20-week study period
Measured: baseline to week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start12 Aug 2021
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ChangeStudies 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
- Parallel groups
- Model description
- This is a free-living prospective, randomized, double-blind, parallel study design with 31 subjects in free-living conditions. subjects will be randomized to receive either Q CAN powder or placebo powder for 12 weeks.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 62 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
- NCT04866576
- Sponsor's protocol ID
- 5210161
- Acronym
- IS
- Status last verified
- Dec 2025
- First submitted
- 15 Mar 2021
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Fermented Soy Product on Cognition, Immune Status and Response to Influenza Vaccine in Elderly Men and Women
- ClinicalTrials.gov ID
- NCT04866576
- Acronym / sponsor ID
- IS / 5210161
- Conditions
- Cognitive Change, Inflammation, Immune Response
- Keywords
- Fermented Soy, Cognition, Inflammation, Immunity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 12 Aug 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 30 Apr 2021 (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.
The research study will test the effects of Q CAN PLUS powder on the immune, inflammatory and cognitive functions.
Detailed description
The purpose of this study is to determine the effects of a fermented soy product (Q-CAN), compared to placebo, on the immune, inflammatory and cognitive functions of elderly individuals. The study intervention will be four months in length. sixty two participants , 65 years or older will be randomized to participate in the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a free-living prospective, randomized, double-blind, parallel study design with 31 subjects in free-living conditions. subjects will be randomized to receive either Q CAN powder or placebo powder for 12 weeks.
| Arm | Type | Receives |
|---|---|---|
| Q CAN PLUS POWDER | Experimental | Dietary Supplement: Q CAN PLUSQCAN PLUS POWDER: 2 pouches per day, each pouch contains (12-15 gms 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
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Elderly men and women, 65 years of age or older
- Ambulatory
- Able to accommodate the intervention food products
- Live in or around Loma Linda to be able to commute to the Nutrition Research Center
Key exclusion criteria (7 listed)
- Intolerance to soy products
- Immune system insufficiency or disease
- Insulin dependent diabetes mellitus
- Alzheimer's disease
- Dialysis
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 |
| PlaceboMaltodextrin powder with Whey protein and flavor (provided by BESO Biological Research, Inc.) | Dietary supplement | Placebo |
Primary outcome
Changes in immune status measurements
Time frame: baseline to week 16
Immune status measurements will be performed using both static and functional tests on whole blood, serum and peripheral blood mononuclear cells (PBMC). Phlebotomy to obtain the needed samples will be performed at baseline (week 0) and at 16 weeks. Changes in immune status include changes in: (a) lymphocyte activity and cytokine production (b) natural killer cells activity, (c) lymphocyte subsets, and (d) inflammatory markers and cytokines.
Changes in lymphocyte activity and cytokine production
Time frame: baseline to week 16
Lymphocyte activity and cytokine production will be measured using enzyme-linked immunoassay (ELISA) and flow cytometry. Peripheral blood mononuclear cells (PBMCs) will be incubated and stimulated with or without phytohemagglutinin (PHA) or Lipopolysaccharide (LPS) and the culture supernatant fluids collected and assayed using ELISA for the following cytokines: granulocyte macrophage colony- stimulating Factor (GM-CSF), tumor necrosis factor alpha (TNF-α), interferon gamma (IFN-γ), interleukin 1 beta (IL-1β), interleukin 2 (IL-2), interleukin 6 (IL-6), and interleukin 10 (IL-10).
Changes in lymphocyte subsets
Time frame: baseline to week 16
Immunophenotyping will be performed on cryopreserved PBMCs using a flow cytometry. The following markers will be measured: T cytotoxic cells (Tc; CD3+CD8+), T helper cells (Th; CD3+CD4+), B cells (CD19+), NK cells (NK; CD3-CD16+), and regulatory T cells (Treg; CD3+CD4+CD25+Foxp3+).
Changes in inflammatory factors and cytokines
Time frame: baseline to week 16
Inflammatory markers in serum will be measured by ELISA and will include C-reactive protein (CRP), E-selectin, Pentraxin 3, Rantes, MCP-1 and Eotaxin. Immunophenotyping will be performed on cryopreserved PBMCs using a flow cytometry. The following markers will be measured: T cytotoxic cells (Tc; CD3+CD8+), T helper cells (Th; CD3+CD4+), B cells (CD19+), NK cells (NK; CD3-CD16+), and regulatory T cells (Treg; CD3+CD4+CD25+Foxp3+). Additional characterization of T cells based on naive and memory phenotypes will be determined by corresponding patterns in the expression of CD45RA, CD45RO and CD62L, while different subpopulations of Tregs will be further differentiated by expressions of GITR, CTLA-4 and LAG-3
Changes in complete blood count (CBC) and differential count
Time frame: baseline to week 16
CBC and the differential counts will be performed on whole blood with the use of an automated hematology analyzer at a certified clinical facility. Immunophenotyping will be performed on cryopreserved PBMCs using a flow cytometry. The following markers will be measured: T cytotoxic cells (Tc; CD3+CD8+), T helper cells (Th; CD3+CD4+), B cells (CD19+), NK cells (NK; CD3-CD16+), and regulatory T cells (Treg; CD3+CD4+CD25+Foxp3+). Additional characterization of T cells based on naive and memory phenotypes will be determined by corresponding patterns in the expression of CD45RA, CD45RO and CD62L, while different subpopulations of Tregs will be further differentiated by expressions of GITR, CTLA-4 and LAG-3
2 secondary outcomes
Changes from baseline in global cognitive composite score
Time frame: baseline to week 16
Changes in the upper respiratory infection questionnaire score
Time frame: baseline to week 16
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 9 Dec 2025.
- 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 Cognitive Change and Inflammation, 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 4 inclusion and 7 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 9 Dec 2025. 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?
Changes in immune status measurements (time frame: baseline to week 16). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Dec 2025.