Evaluation of the Effect of a Combination of Plant Extracts (BSL_EP027) on the Incidence of Respiratory Infections

Study Overview
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Brief Summary
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The objective of the present study is to evaluate the effectiveness of daily consumption of a Combination of Plant Extracts (BSL_EP027) on the incidence of respiratory infection symptoms and their duration in older healthy volunteers living in a nursing home.

Detailed Description
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A prevalence of deficient immune state is estimated at 44% of the world's population, a figure that rises in the senior population group. Traditionally, protection against infection and improvement of the immune response has been addressed through the use of plant extracts. An effective immune response involves the action of both innate and specific responses and the perfect coordination between both. Natural strategies that can activate both types of immune response can lead to more effective treatments. Our hypothesis is that the different effects of the combination of several plant extracts can lead to a synergy that generates a more effective product in the prevention of respiratory infections, especially in susceptible populations such as the elderly.

Official Title
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Preliminary Study on the Effect of Consuming a Combination of Plant Extracts (BSL_EP027) on the Incidence of Respiratory Infection Symptoms in Healthy Elderly Living in a Nursing Home.

Conditions
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Immune Response, Respiratory Diseases

Intervention / Treatment
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* Combination Product: Combination of plant extracts (BSL_EP027)
* Combination Product: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Living in a nursing home with medical service. Freely accept to participate in the study and sign the informed consent document. Exclusion Criteria: Having a disease that affects the development and results of the study. Suffer alterations of the state of health incompatible with the continuity in the study. Suffer any adverse event not tolerated by the subject.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combination of plant extracts (BSL_EP027)<br>Volunteers will dissolve in water a sachet per day with the Combination of plant extracts (BSL_EP027), and maltodextrin. | Combination Product: Combination of plant extracts (BSL_EP027)<br>* Each participant will consume a sachet disolve in water once at day without any restriction in the diet nor in their habits of life.<br>|
| Placebo Comparator: Placebo<br>Volunteers will dissolve in water a sachet per day with maltodextrin. | Combination Product: Placebo<br>* Each participant will consume a sachet disolve in water once at day without any restriction in the diet nor in their habits of life.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory infection symptoms | Incidence of respiratory infection symptoms (fiber, cough, rinitis, headache, sore throat, bone and/or muscle pain, fatigue/exhaustion, nausea and/or vomiting, lack of appetite and /or trouble for sleeping) | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of the respiratory infection symptoms | Duration of the respiratory infection symptoms (days) | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunostimulation, Respiratory diseases, Plant extracts