SUPPLEMENTATION WITH BETA GLUCAN AND ADAPTATIVE RESPONSE.

Federal University of São Paulo

Status: Begins enrollment this month

Conditions: Clinical Course

Treatments: Dietary Supplement: BioNutri AR-1,

Study type: Interventional

Funder types: Other

Identifiers

NCT06545149

73701723.8.0000.0281

Details and patient eligibility

About

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.

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients admitted to the medical clinic ward

Exclusion criteria

Patients unable to swallow

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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44 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

The group will receive the intervention with coconut wheat

Treatment:

Dietary Supplement: BioNutri AR-1,

BioNutri AR-1

Experimental group

Description:

The group will receive the intervention with fermented and nutritionally balanced food

Treatment:

Dietary Supplement: BioNutri AR-1,