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

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ClinicalTrials.gov Identifier: NCT04029558
Recruitment Status : Completed
First Posted : July 23, 2019
Last Update Posted : November 18, 2019
Sponsor:
Information provided by (Responsible Party):
Biosearch S.A.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Immune Response Dietary Supplement: Combination of Plant Extracts (BSL_EP025) Dietary Supplement: Placebo Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : June 3, 2019
Actual Primary Completion Date : July 3, 2019
Actual Study Completion Date : July 3, 2019
Arms and Interventions
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Arm Intervention/treatment
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.
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.


Outcome Measures
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Primary Outcome Measures :
  1. IgM [ Time Frame: 4 weeks ]
    Immunoglobulin M plasma levels

  2. IgA [ Time Frame: 4 weeks ]
    Immunoglobulin A plasma levels

  3. IgG [ Time Frame: 4 weeks ]
    Immunoglobulin G plasma levels


Secondary Outcome Measures :
  1. IL-2 [ Time Frame: 4 weeks ]
    Plasma levels of interleukin-2

  2. IL-8 [ Time Frame: 4 weeks ]
    Plasma levels of interleukin-8

  3. TNF-alpha [ Time Frame: 4 weeks ]
    Plasma levels of tumor necrosis factor alpha


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04029558


Locations
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Spain
Biosearch Life
Granada, Andalucia, Spain, 18004
Sponsors and Collaborators
Biosearch S.A.
Investigators
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Study Chair: Miguel Quesada, MD, PhD Medical specialist in Endocrinology, Hospital San Cecilio de Granada
More Information
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Responsible Party: Biosearch S.A.
ClinicalTrials.gov Identifier: NCT04029558    
Other Study ID Numbers: C024
First Posted: July 23, 2019    Key Record Dates
Last Update Posted: November 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Biosearch S.A.:
Immune response
Plant extracts
Dietary supplement