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Completed

NCT Number: NCT04029558

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

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.

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Key information

Conditions

Immune Response

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Biosearch Life

Granada, Andalusia, 18004, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Combination of Plant Extracts (BSL_EP025)

Dietary Supplement

Each participant will consume 2 capsules daily at lunch for 8 weeks.

Placebo

Dietary Supplement

Each participant will consume 2 capsules daily at lunch for 8 weeks.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Biosearch S.A.

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 23, 2019
Registry last updated
Nov 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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