Clinical trial NCT04866576: Effect of a Fermented Soy Product on Cognition, Immune Status and Vaccine
Official title: Effect of a Fermented Soy Product on Cognition, Immune Status and Response to Influenza Vaccine in Elderly Men and Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Change
Inflammation
Immune Response
Keywords: Fermented Soy
Cognition
Inflammation
Immunity
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2021-04-30
Enrollment: 62
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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

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.

Eligibility 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

Primary outcomes:
measure: Changes in immune status measurements
timeFrame: baseline to week 16
measure: Changes in lymphocyte activity and cytokine production
timeFrame: baseline to week 16
measure: Changes in natural killer (NK) cell activity
timeFrame: baseline to week 16
measure: Changes in lymphocyte subsets
timeFrame: baseline to week 16
measure: Changes in inflammatory factors and cytokines
timeFrame: baseline to week 16
measure: Changes in complete blood count (CBC) and differential count
timeFrame: baseline to week 16
measure: Changes in neutralizing antibody titers against hemagglutinin and neuraminidase of the vaccine strain.
timeFrame: week 16 to week 20
measure: Changes in the viral load in response to vaccination
timeFrame: week 16 to week 20
Secondary outcomes:
measure: Changes from baseline in global cognitive composite score
timeFrame: baseline to week 16
measure: Changes in the upper respiratory infection questionnaire score
timeFrame: baseline to week 20
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University School of Public Health
state: California
Study officials:
affiliation: Loma Linda University
name: Joan Sabate, DrPH
role: PRINCIPAL_INVESTIGATOR
References: