SUPPLEMENTATION WITH BETA GLUCAN AND ADAPTATIVE RESPONSE.
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
1 other identifier
interventional
44
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2024
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 2, 2024
CompletedFirst Posted
Study publicly available on registry
August 9, 2024
CompletedStudy Start
First participant enrolled
October 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedAugust 9, 2024
August 1, 2024
1 year
July 2, 2024
August 6, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
length of hospital stay
during hospitalization
Secondary Outcomes (2)
need for readmission
up to 24 weeks
need for ICU
up to 24 weeks
Study Arms (2)
Control
PLACEBO COMPARATORThe group will receive the intervention with coconut wheat
BioNutri AR-1
EXPERIMENTALThe group will receive the intervention with fermented and nutritionally balanced food
Interventions
intervention with fermented and nutritionally balanced food twice a day
Eligibility Criteria
You may qualify if:
- Patients admitted to the medical clinic ward
You may not qualify if:
- Patients unable to swallow
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Federal University of São Paulolead
- Kaiser Clinic and Hospitalcollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
July 2, 2024
First Posted
August 9, 2024
Study Start
October 1, 2024
Primary Completion
October 1, 2025
Study Completion
December 1, 2025
Last Updated
August 9, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share