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

Immune Response Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04029558
• Other study ID #: C024
• Status: Completed
• Phase: N/A
• Start date: June 3, 2019
• Est. completion date: July 3, 2019

Study information

• Verified date: July 2019
• Source: Biosearch S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: July 3, 2019
• Est. primary completion date: July 3, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Immune Response

Intervention

Dietary Supplement:
• Combination of Plant Extracts (BSL_EP025)
Each participant will consume 2 capsules daily at lunch for 8 weeks.
• Placebo
Each participant will consume 2 capsules daily at lunch for 8 weeks.

Locations

Country	Name	City	State
Spain	Biosearch Life	Granada	Andalucia

Sponsors (1)

Lead Sponsor	Collaborator
Biosearch S.A.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IgM	Immunoglobulin M plasma levels	4 weeks
Primary	IgA	Immunoglobulin A plasma levels	4 weeks
Primary	IgG	Immunoglobulin G plasma levels	4 weeks
Secondary	IL-2	Plasma levels of interleukin-2	4 weeks
Secondary	IL-8	Plasma levels of interleukin-8	4 weeks
Secondary	TNF-alpha	Plasma levels of tumor necrosis factor alpha	4 weeks