Effect of a Fermented Soy Product on Cognition, Immune Status and Vaccine

Study Overview
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Brief Summary
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The research study will test the effects of Q CAN PLUS powder on the immune, inflammatory and cognitive functions.

Detailed Description
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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.

Official Title
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Effect of a Fermented Soy Product on Cognition, Immune Status and Response to Influenza Vaccine in Elderly Men and Women

Conditions
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Cognitive Change, Inflammation, Immune Response

Intervention / Treatment
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* Dietary Supplement: Q CAN PLUS
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Q CAN PLUS POWDER<br>QCAN PLUS POWDER: 2 pouches per day, each pouch contains (12-15 gms of fermented soy powder) | Dietary Supplement: Q CAN PLUS<br>* Active powder with fermented soy, 2 pouches per day, each pouch contains 12-15 gms of fermented soy<br>|
| Placebo Comparator: Placebo<br>Sprouted brown rice protein with flavor (provided by BESO Biological Research Inc.) | Dietary Supplement: Placebo<br>* Maltodextrin powder with Whey protein and flavor (provided by BESO Biological Research, Inc.)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | baseline to week 16 | 
| Changes in natural killer (NK) cell activity | 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 | 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 | 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 | 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. | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fermented Soy, Cognition, Inflammation, Immunity