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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | Microcrystalline cellulose (9892- Capsules®) up to 400 mg. |
|
| Intervention | Experimental | Garlic concentrated extract plus onion concentrated extract plus microcrystalline cellulose (9892- Capsules®) up to 400 mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Garlic and onion concentrate | Dietary Supplement | Garlic extract concentrate (equivalent to 2 garlic cloves) and onion extract concentrate (equivalent to 1 onion). |
|
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos Gracián, MD | Claret Residence for the Elderly (Granada, Spain). | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Residencia de Mayores Claret | Granada | 18012 | Spain |
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| ID | Term |
|---|---|
| D005079 | Excipients |
| ID | Term |
|---|---|
| D014677 | Pharmaceutical Vehicles |
| D010592 | Pharmaceutic Aids |
| D004364 | Pharmaceutical Preparations |
| D020313 | Specialty Uses of Chemicals |
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Each volunteer is assigned a "participant number" that will be associated with a pot that will have all the product for the study.
The "pot number" is the same as the "participant number". The pot does not indicate which product it is carrying.
|
| Control | Dietary Supplement | Microcrystalline cellulose |
|
|
If the volunteer has had any symptoms related to respiratory diseases of infectious origin, every 4 weeks treatment applied will be reviewed.
| 36 weeks |
| D020164 | Chemical Actions and Uses |