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

Browse trials for

• Inflammation 3,439

Keywords

• Fermented Soy
• Cognition
• Inflammation
• Immunity

Inflammation

3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.

This study's enrollment of 62 is above the median of 50 across 2,437 interventional studies indexed under Inflammation.

Lead sponsor

Loma Linda University is the lead sponsor of 297 studies on the registry; 48 are open to participants now.

Of its 28 completed or terminated interventional studies of FDA-regulated products, 23 (82%) have results posted.

Study arms

• 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

• Placebo comparator
  Placebo

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

  Dietary Supplement: Placebo

Interventions

• Dietary supplementQ CAN PLUS

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

• Dietary supplementPlacebo

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

Primary outcomes

1. 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.

   Time frame: baseline to week 16

2. 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).

   Time frame: baseline to week 16

3. 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+).

   Time frame: baseline to week 16

4. 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

   Time frame: baseline to week 16

5. 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

   Time frame: baseline to week 16

Secondary outcomes

1. 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).

   Time frame: baseline to week 16

2. 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

   Time frame: baseline to week 16

Individual participant data

Plan to share: No