SUPPLEMENTATION WITH BETA GLUCAN AND ADAPTATIVE RESPONSE.

August 6, 2024 updated by: FERNANDO SABIA TALLO, Federal University of São Paulo

SUPPLEMENTATION WITH FERMENTED AND BALANCED FOOD WITH BETA GLUCAN FAVORS THE INNATE AND ADAPTATIVE RESPONSE OF PATIENTS ADMITTED TO A MEDICAL CLINIC WARD? A RANDOMIZED TRIAL

Abstract: Studies demonstrate that the use of nutritional supplements containing beta-glucans stimulates the immune system, modulates inflammatory activity, and promotes so-called immune training. Beta-glucans are prebiotics that stimulate the growth and activity of gastrointestinal microbiota and inhibit pathogen growth. Nutritional intervention is crucial for patients' positive evolution, and providing a supplement with highly bioavailable nutrients can make a difference in their nutritional, metabolic, and immune status. Therefore, the study aims to verify the effectiveness of the innate and adaptive immune response to a nutritionally balanced fermented food, containing oral or enteral beta-glucans, in patients treated at 3 Emergency Care Units in São José do Rio Preto, São Paulo, Brazil. This is a prospective randomized study with a characteristic design involving patients treated in the medical wards of 3 Emergency Care Unit. The following assessments will be conducted: Global Subjective Assessment for adults and Mini Nutritional Assessment for the elderly, Sociodemographic, and Laboratory Evaluation.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: FERNANDO SABIA TALLO, PhD
  • Phone Number: +55 11 971554018
  • Email: fstallo@unifesp.br

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Patients admitted to the medical clinic ward

Exclusion Criteria:

Patients unable to swallow

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
The group will receive the intervention with coconut wheat
Dietary supplement: BioNutri AR-1,
intervention with fermented and nutritionally balanced food twice a day
Experimental: BioNutri AR-1
The group will receive the intervention with fermented and nutritionally balanced food
Dietary supplement: BioNutri AR-1,
intervention with fermented and nutritionally balanced food twice a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
length of hospital stay
Time Frame: during hospitalization
during hospitalization

Secondary Outcome Measures

Outcome Measure
Time Frame
need for readmission
Time Frame: up to 24 weeks
up to 24 weeks
need for ICU
Time Frame: up to 24 weeks
up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Collaborators

Kaiser Clinic and Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2024

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

July 2, 2024

First Submitted That Met QC Criteria

August 6, 2024

First Posted (Actual)

August 9, 2024

Study Record Updates

Last Update Posted (Actual)

August 9, 2024

Last Update Submitted That Met QC Criteria

August 6, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 73701723.8.0000.0281

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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