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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Pilot Study of Nutritional Intervention, Randomized, Double Blind and Controlled Parallel Groups to Evaluate the Effect of the Consumption of the Combination of Plant Extracts (BSL_EP024) on the Immune Response in Adults

Conditions
-----------------
Immune Response

Intervention / Treatment
-----------------
* Dietary Supplement: Combination of Plant Extracts (BSL_EP025)
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combination of plant extracts (BSL_EP024)<br>The volunteers will take two capsules daily with a combination of plant extracts (BSL_EP024) | Dietary Supplement: Combination of Plant Extracts (BSL_EP025)<br>* Each participant will consume 2 capsules daily at lunch for 8 weeks.<br>|
| Placebo Comparator: Placebo<br>The volunteers will take two capsules daily with maltodextrin. | Dietary Supplement: Placebo<br>* Each participant will consume 2 capsules daily at lunch for 8 weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IgM | Immunoglobulin M plasma levels | 4 weeks | 
| IgA | Immunoglobulin A plasma levels | 4 weeks | 
| IgG | Immunoglobulin G plasma levels | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IL-2 | Plasma levels of interleukin-2 | 4 weeks | 
| IL-8 | Plasma levels of interleukin-8 | 4 weeks | 
| TNF-alpha | Plasma levels of tumor necrosis factor alpha | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Immune response, Plant extracts, Dietary supplement