Allium Extracts on the Incidence of Respiratory Infection Symptoms in Healthy Elderly Volunteers

Study Overview
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Brief Summary
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To analyze the efficacy of daily consumption of a combination of garlic and onion extracts on the incidence of respiratory infection symptoms in healthy elderly volunteers living in a residence. The duration of symptoms and related medication will also be studied.

Detailed Description
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It is a controlled, randomized, double-blind, parallel-group nutritional intervention study. 66 healthy elderly volunteers living in a nursing home will be randomly distributed into 2 equal groups: control group and intervention group. For 36 weeks the volunteers will take the product immediately after lunch. During that time they will maintain their lifestyle and nutritional habits. Every 4 weeks, the medical team of the residence will review the cases of respiratory diseases of infectious origin of the volunteers.

Official Title
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Study of the Effect of the Consumption of a Combination of Allium Extracts on the Incidence of Symptoms of Respiratory Infections in Healthy Elderly Residents

Conditions
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Immunity

Intervention / Treatment
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* Dietary Supplement: Garlic and onion concentrate
* Dietary Supplement: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Live in a nursing home with medical services. Accept being vaccinated for the flu. Freely accepted to participate in the study and sign the informed consent document. Have the consent of the family. Exclusion Criteria: Having any disease that affects the development and results of the study. Be unable to understand the study and sign voluntarily and freely the informed consent. Have a low expectation of compliance with the study protocol.

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Microcrystalline cellulose (9892- Capsules®) up to 400 mg. | Dietary Supplement: Garlic and onion concentrate<br>* Garlic extract concentrate (equivalent to 2 garlic cloves) and onion extract concentrate (equivalent to 1 onion).<br>* Other names: AlioCare;Dietary Supplement: Control<br>* Microcrystalline cellulose<br>* Other names: Excipient;|
| Experimental: Intervention<br>Garlic concentrated extract plus onion concentrated extract plus microcrystalline cellulose (9892- Capsules®) up to 400 mg. | Dietary Supplement: Garlic and onion concentrate<br>* Garlic extract concentrate (equivalent to 2 garlic cloves) and onion extract concentrate (equivalent to 1 onion).<br>* Other names: AlioCare;Dietary Supplement: Control<br>* Microcrystalline cellulose<br>* Other names: Excipient;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of respiratory symptoms associated with infections. | It will be reviewed if the volunteer has had any symptoms related to respiratory diseases of infectious origin. | 36 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of symptoms. | If the volunteer has had any symptoms related to respiratory diseases of infectious origin, every 4 weeks duration of these symptoms will be reviewed. | 36 weeks | 
| Consumption of medicines. | If the volunteer has had any symptoms related to respiratory diseases of infectious origin, every 4 weeks treatment applied will be reviewed. | 36 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunity, Garlic, Onion