SUPPLEMENTATION WITH BETA GLUCAN AND ADAPTATIVE RESPONSE.

Not Applicable

Not yet recruiting

• Conditions: Clinical Course
• Interventions: Dietary Supplement: BioNutri AR-1,

• Registration Number: NCT06545149
• Lead Sponsor: Federal University of São Paulo

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-02
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-06
• Last Update Submitted: 2024-08-06
• Study First Posted: 2024-08-09
• Last Update Posted: 2024-08-09
• Study Start: 2024-10
• Primary Completion: 2025-10
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Patients admitted to the medical clinic ward

Exclusion Criteria

Patients unable to swallow

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	BioNutri AR-1,	The group will receive the intervention with coconut wheat
BioNutri AR-1	BioNutri AR-1,	The group will receive the intervention with fermented and nutritionally balanced food

Primary Outcome Measures

Name	Time	Method
length of hospital stay	during hospitalization

Secondary Outcome Measures

Name	Time	Method
need for readmission	up to 24 weeks
need for ICU	up to 24 weeks