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

Not Applicable

Completed

• Conditions: Immune Response
• Interventions: Dietary Supplement: Combination of Plant Extracts (BSL_EP025); Dietary Supplement: Placebo

• Registration Number: NCT04029558
• Lead Sponsor: Biosearch S.A.

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.

Study Timeline

• Study Start: 2019-06-03
• Status Verified: 2019-07
• Primary Completion: 2019-07-03
• Study Completion: 2019-07-03
• Study First Submitted: 2019-07-22
• Study First Submitted QC: 2019-07-22
• Study First Posted: 2019-07-23
• Last Update Submitted: 2019-11-14
• Last Update Posted: 2019-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combination of plant extracts (BSL_EP024)	Combination of Plant Extracts (BSL_EP025)	The volunteers will take two capsules daily with a combination of plant extracts (BSL_EP024)
Placebo	Placebo	The volunteers will take two capsules daily with maltodextrin.

Primary Outcome Measures

Name	Time	Method
IgM	4 weeks	Immunoglobulin M plasma levels
IgA	4 weeks	Immunoglobulin A plasma levels
IgG	4 weeks	Immunoglobulin G plasma levels

Secondary Outcome Measures

Name	Time	Method
IL-8	4 weeks	Plasma levels of interleukin-8
IL-2	4 weeks	Plasma levels of interleukin-2
TNF-alpha	4 weeks	Plasma levels of tumor necrosis factor alpha

Trial Locations

Locations (1)

Biosearch Life; 🇪🇸 Granada, Andalucia, Spain