Effect of a Combination of Plant Extracts (BSL_EP024) on the Immune Response

Biosearch S.A.41 enrolled

Overview

The aim of the present trial is to study the effect of the combination of plant extracts (BSL\_EP024) in the activation of the immune response.

More than 90% of the diseases are related, directly or indirectly, with immune alterations. Traditionally, protection against infections and improvement of the immune response has been addressed by natural means through the use of plant extracts. This activity has been attributed to phenolic compounds. The aim of the present study is to evaluate the effect of the combination of plant extracts (BSL\_EP024) on immunological response parameters.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Immune Response

Interventions

Combination of Plant Extracts (BSL_EP025)DIETARY_SUPPLEMENT

Each participant will consume 2 capsules daily at lunch for 8 weeks.

PlaceboDIETARY_SUPPLEMENT

Each participant will consume 2 capsules daily at lunch for 8 weeks.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy adult between 18 and 55 years. * Accept freely to participate in the study and sign the informed consent document. Exclusion Criteria: * Be under pharmacological treatments that may affect the immune response (anti-inflammatory drugs of chronic or frequent use, antiallergic treatments). * Have allergy to some plant extracts * Suffer from gastric problems or ulcers. * Receive treatment with anticoagulant activity. * Have a low expectation of adherence to the study protocol.

Locations (1)

Biosearch Life

Granada, Andalusia, Spain

Outcomes

Primary Outcomes

IgM

Immunoglobulin M plasma levels

Time frame: 4 weeks

IgA

Immunoglobulin A plasma levels

Time frame: 4 weeks

IgG

Immunoglobulin G plasma levels

Time frame: 4 weeks

Secondary Outcomes

IL-2

Plasma levels of interleukin-2

Time frame: 4 weeks

IL-8

Plasma levels of interleukin-8

Time frame: 4 weeks

TNF-alpha

Plasma levels of tumor necrosis factor alpha

Time frame: 4 weeks

Data from ClinicalTrials.gov

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