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

NCT ID: NCT04866576

Last Updated: 2025-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-12

Study Completion Date

2022-03-01

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.

Conditions

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Cognitive Change Inflammation Immune Response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
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.

Study Groups

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Q CAN PLUS POWDER

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

Group Type EXPERIMENTAL

Q CAN PLUS

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Q CAN PLUS

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

65 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Loma Linda University

OTHER

Sponsor Role lead

Responsible Party

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Joan Sabate,DrPH, MD

MD, DrPH

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joan Sabate, DrPH

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University

Locations

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Loma Linda University School of Public Health

Loma Linda, California, United States

Site Status

Countries

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United States

Other Identifiers

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5210161

Identifier Type: -

Identifier Source: org_study_id

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