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

Not Applicable

Completed

• Conditions: Immunity
• Interventions: Dietary Supplement: Garlic and onion concentrate; Dietary Supplement: Control

• Registration Number: NCT04647071
• Lead Sponsor: DOMCA S.A.

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-10-22
• Status Verified: 2020-11
• Study Start: 2020-11-16
• Study First Submitted QC: 2020-11-27
• Study First Posted: 2020-11-30
• Primary Completion: 2021-07-26
• Study Completion: 2022-01-31
• Last Update Submitted: 2022-05-20
• Last Update Posted: 2022-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	Microcrystalline cellulose (9892- Capsules®) up to 400 mg.
Intervention	Control	Garlic concentrated extract plus onion concentrated extract plus microcrystalline cellulose (9892- Capsules®) up to 400 mg.
Intervention	Garlic and onion concentrate	Garlic concentrated extract plus onion concentrated extract plus microcrystalline cellulose (9892- Capsules®) up to 400 mg.
Control	Garlic and onion concentrate	Microcrystalline cellulose (9892- Capsules®) up to 400 mg.

Primary Outcome Measures

Name	Time	Method
Incidence of respiratory symptoms associated with infections.	36 weeks.	It will be reviewed if the volunteer has had any symptoms related to respiratory diseases of infectious origin.

Secondary Outcome Measures

Name	Time	Method
Duration of symptoms.	36 weeks	If the volunteer has had any symptoms related to respiratory diseases of infectious origin, every 4 weeks duration of these symptoms will be reviewed.
Consumption of medicines.	36 weeks	If the volunteer has had any symptoms related to respiratory diseases of infectious origin, every 4 weeks treatment applied will be reviewed.

Trial Locations

Locations (1)

Residencia de Mayores Claret; 🇪🇸 Granada, Spain