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

• ClinicalTrials.gov Identifier: NCT04866576
• Recruitment Status: Recruiting
• First Posted: April 30, 2021
• Last Update Posted: January 12, 2022
• Sponsor: Loma Linda University
• Information provided by (Responsible Party): Joan Sabate,DrPH, MD, Loma Linda University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Cognitive Change; Inflammation; Immune Response	Dietary Supplement: Q CAN PLUS; Dietary Supplement: Placebo	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 62 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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 (Participant, Care Provider, Outcomes Assessor)
• Masking Description: The participants, study personnel and the data analysts will not be aware of which powder is the active powder and which one is the placebo. Only Principle Investigator will be made aware.
• Primary Purpose: Prevention
• Official Title: Effect of a Fermented Soy Product on Cognition, Immune Status and Response to Influenza Vaccine in Elderly Men and Women
• Actual Study Start Date: August 12, 2021
• Estimated Primary Completion Date: March 31, 2022
• Estimated Study Completion Date: December 31, 2022

Arms and Interventions

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)	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; Maltodextrin powder with Whey protein and flavor (provided by BESO Biological Research, Inc.)

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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).
3. 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.
4. 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+).
5. 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

6. 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

7. 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.
8. 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).

Secondary Outcome Measures :

1. 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).

2. 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

Eligibility Criteria

• Ages Eligible for Study: 65 Years to 80 Years (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Contacts

Contact: Amandeep Kaur, MPH; 909-558-4300 ext 47169; akaur1@llu.edu

Contact: Ifeanyi Nwachukwu, PhD; nwachukwu@llu.edu

Locations

United States, California

Loma Linda University School of Public Health; Recruiting

Loma Linda, California, United States, 92350

Sponsors and Collaborators

Loma Linda University

Investigators

• Principal Investigator: Joan Sabate, DrPH; Loma Linda University

More Information

• Responsible Party: Joan Sabate,DrPH, MD, MD, DrPH, Loma Linda University
• ClinicalTrials.gov Identifier: NCT04866576
• Other Study ID Numbers: 5210161
• First Posted: April 30, 2021
• Last Update Posted: January 12, 2022
• Last Verified: January 2022

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; Cognition; Inflammation; Immunity

Additional relevant MeSH terms:

Inflammation; Pathologic Processes