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Clinical Trials/NCT06545149
NCT06545149
Not yet recruiting
Not Applicable

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

Federal University of São Paulo0 sites44 target enrollmentStarted: October 2024Last updated:
ConditionsClinical Course

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Federal University of São Paulo
Enrollment
44
Primary Endpoint
length of hospital stay

Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 100 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients admitted to the medical clinic ward

Exclusion Criteria

  • Patients unable to swallow

Outcomes

Primary Outcomes

length of hospital stay

Time Frame: during hospitalization

Secondary Outcomes

  • need for ICU(up to 24 weeks)
  • need for readmission(up to 24 weeks)

Investigators

Sponsor
Federal University of São Paulo
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

FERNANDO SABIA TALLO

Clinical Professor

Federal University of São Paulo

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