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Clinical Trials/NCT04029558
NCT04029558
Completed
Not Applicable

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

Biosearch S.A.1 site in 1 country41 target enrollmentJune 3, 2019
ConditionsImmune Response

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Immune Response
Sponsor
Biosearch S.A.
Enrollment
41
Locations
1
Primary Endpoint
IgG
Status
Completed
Last Updated
6 years ago

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.

Registry
clinicaltrials.gov
Start Date
June 3, 2019
End Date
July 3, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Biosearch S.A.
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

IgG

Time Frame: 4 weeks

Immunoglobulin G plasma levels

IgM

Time Frame: 4 weeks

Immunoglobulin M plasma levels

IgA

Time Frame: 4 weeks

Immunoglobulin A plasma levels

Secondary Outcomes

  • TNF-alpha(4 weeks)
  • IL-8(4 weeks)
  • IL-2(4 weeks)

Study Sites (1)

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