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

NCT04866576 | Completed

• 1 other identifier: 5210161
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Immune Response; Cognitive Change; Inflammation

Keywords

Fermented Soy; Cognition; Inflammation; Immunity

Outcome Measures

Primary Outcomes (5)

• 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 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

Secondary Outcomes (2)

• Changes from baseline in global cognitive composite score

  baseline to week 16

• Changes in the upper respiratory infection questionnaire score

  baseline to week 16

Study Arms (2)

Q CAN PLUS POWDER

EXPERIMENTAL

QCAN PLUS POWDER: 2 pouches per day, each pouch contains (12-15 gms of fermented soy powder)

Dietary Supplement: Q CAN PLUS

Placebo

PLACEBO COMPARATOR

Sprouted brown rice protein with flavor (provided by BESO Biological Research Inc.)

Dietary Supplement: Placebo

Interventions

Q CAN PLUS DIETARY_SUPPLEMENT

Active powder with fermented soy, 2 pouches per day, each pouch contains 12-15 gms of fermented soy

Q CAN PLUS POWDER

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University School of Public Health

Loma Linda, California, 92350, United States

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Joan Sabate, DrPH

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, DrPH

Model Details: 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.

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: April 30, 2021
• Study Start: August 12, 2021
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)