SUPPLEMENTATION WITH BETA GLUCAN AND ADAPTATIVE RESPONSE.

NCT ID: NCT06545149

Last Updated: 2024-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-31

Study Completion Date

2025-12-31

Brief Summary

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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

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Conditions

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Clinical Course

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Control

The group will receive the intervention with coconut wheat

Group Type PLACEBO_COMPARATOR

BioNutri AR-1,

Intervention Type DIETARY_SUPPLEMENT

intervention with fermented and nutritionally balanced food twice a day

BioNutri AR-1

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

Group Type EXPERIMENTAL

BioNutri AR-1,

Intervention Type DIETARY_SUPPLEMENT

intervention with fermented and nutritionally balanced food twice a day

Interventions

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BioNutri AR-1,

intervention with fermented and nutritionally balanced food twice a day

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

Patients admitted to the medical clinic ward

Exclusion Criteria

Patients unable to swallow
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaiser Clinic and Hospital

OTHER

Sponsor Role collaborator

Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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FERNANDO SABIA TALLO

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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FERNANDO SABIA TALLO, PhD

Role: CONTACT

+55 11 971554018

Other Identifiers

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73701723.8.0000.0281

Identifier Type: -

Identifier Source: org_study_id

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