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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04029558

Enrollment

Registered

2019-07-23

Start date

2019-06-03

Completion date

2019-07-03

Last updated

2019-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immune Response

Keywords

Immune response, Plant extracts, Dietary supplement

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.

Interventions

DIETARY_SUPPLEMENTCombination of Plant Extracts (BSL_EP025)

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

DIETARY_SUPPLEMENTPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
IgM	4 weeks	Immunoglobulin M plasma levels
IgA	4 weeks	Immunoglobulin A plasma levels
IgG	4 weeks	Immunoglobulin G plasma levels

Secondary

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026