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

Immunity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04647071
• Other study ID #: C002
• Status: Completed
• Phase: N/A
• Start date: November 16, 2020
• Est. completion date: January 31, 2022

Study information

• Verified date: November 2020
• Source: DOMCA S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: January 31, 2022
• Est. primary completion date: July 26, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Immunity
• Respiratory Tract Infections

Intervention

Dietary Supplement:
• Garlic and onion concentrate
Garlic extract concentrate (equivalent to 2 garlic cloves) and onion extract concentrate (equivalent to 1 onion).
• Control
Microcrystalline cellulose

Locations

Country	Name	City	State
Spain	Residencia de Mayores Claret	Granada

Sponsors (1)

Lead Sponsor	Collaborator
DOMCA S.A.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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