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

May 20, 2022 updated by: DOMCA S.A.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Granada, Spain, 18012
        • Residencia de Mayores Claret

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
Microcrystalline cellulose (9892- Capsules®) up to 400 mg.
Dietary supplement: Garlic and onion concentrate
Garlic extract concentrate (equivalent to 2 garlic cloves) and onion extract concentrate (equivalent to 1 onion).
Other Names:
  • AlioCare
Dietary supplement: Control
Microcrystalline cellulose
Other Names:
  • Excipient
Experimental: Intervention
Garlic concentrated extract plus onion concentrated extract plus microcrystalline cellulose (9892- Capsules®) up to 400 mg.
Dietary supplement: Garlic and onion concentrate
Garlic extract concentrate (equivalent to 2 garlic cloves) and onion extract concentrate (equivalent to 1 onion).
Other Names:
  • AlioCare
Dietary supplement: Control
Microcrystalline cellulose
Other Names:
  • Excipient

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of respiratory symptoms associated with infections.
Time Frame: 36 weeks.
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.
Time Frame: 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.
36 weeks
Consumption of medicines.
Time Frame: 36 weeks
If the volunteer has had any symptoms related to respiratory diseases of infectious origin, every 4 weeks treatment applied will be reviewed.
36 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DOMCA S.A.

Investigators

  • Principal Investigator: Carlos Gracián, MD, Claret Residence for the Elderly (Granada, Spain).

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2020

Primary Completion (Actual)

July 26, 2021

Study Completion (Actual)

January 31, 2022

Study Registration Dates

First Submitted

October 22, 2020

First Submitted That Met QC Criteria

November 27, 2020

First Posted (Actual)

November 30, 2020

Study Record Updates

Last Update Posted (Actual)

May 23, 2022

Last Update Submitted That Met QC Criteria

May 20, 2022

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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