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

November 14, 2019 updated by: Biosearch S.A.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Andalucia
      • Granada, Andalucia, Spain, 18004
        • Biosearch Life

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biosearch S.A.

Investigators

  • Study Chair: Miguel Quesada, MD, PhD, Medical specialist in Endocrinology, Hospital San Cecilio de Granada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2019

Primary Completion (Actual)

July 3, 2019

Study Completion (Actual)

July 3, 2019

Study Registration Dates

First Submitted

July 22, 2019

First Submitted That Met QC Criteria

July 22, 2019

First Posted (Actual)

July 23, 2019

Study Record Updates

Last Update Posted (Actual)

November 18, 2019

Last Update Submitted That Met QC Criteria

November 14, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • C024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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