- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04866576
Effect of a Fermented Soy Product on Cognition, Immune Status and Vaccine (IS)
Effect of a Fermented Soy Product on Cognition, Immune Status and Response to Influenza Vaccine in Elderly Men and Women
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Loma Linda, California, United States, 92350
- Loma Linda University School of Public Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Q CAN PLUS POWDER
QCAN PLUS POWDER: 2 pouches per day, each pouch contains (12-15 gms of fermented soy powder)
|
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.)
|
Maltodextrin powder with Whey protein and flavor (provided by BESO Biological Research, Inc.)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
baseline to week 16
|
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).
|
baseline to week 16
|
Changes in natural killer (NK) cell activity
Time Frame: baseline to week 16
|
The NK degranulation assay will be performed on blood samples.
The test will be conducted using a modified flow cytometry method that measures the expression of CD107a.
|
baseline to week 16
|
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+).
|
baseline to week 16
|
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 |
baseline to week 16
|
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 |
baseline to week 16
|
Changes in neutralizing antibody titers against hemagglutinin and neuraminidase of the vaccine strain.
Time Frame: week 16 to week 20
|
Neutralizing antibody titers in the serum against the hemagglutinin and neuraminidase of the vaccine strain will be measured using the standard commercial ELISA kits.
|
week 16 to week 20
|
Changes in the viral load in response to vaccination
Time Frame: week 16 to week 20
|
Viral load in blood will be measured using a quantitative polymerase chain reaction (qPCR) protocol as described by Ward CL, et al. (2004).
|
week 16 to week 20
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes from baseline in global cognitive composite score
Time Frame: baseline to week 16
|
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). |
baseline to week 16
|
Changes in the upper respiratory infection questionnaire score
Time Frame: baseline to week 20
|
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
|
baseline to week 20
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Joan Sabate, DrPH, Loma Linda University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5210161
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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