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
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.
Investigators
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)