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

Sponsor
DOMCA S.A. (Industry)
Overall Status
Completed
CT.gov ID
NCT04647071
Collaborator
(none)
66
Enrollment
1
Location
2
Arms
14.5
Actual Duration (Months)
4.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Garlic and onion concentrate
  • Dietary Supplement: Control
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
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.
Primary Purpose:
Prevention
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
Actual Study Start Date :
Nov 16, 2020
Actual Primary Completion Date :
Jul 26, 2021
Actual Study Completion Date :
Jan 31, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Residencia de Mayores Claret Granada Spain 18012

    Sponsors and Collaborators

    • DOMCA S.A.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    DOMCA S.A.
    ClinicalTrials.gov Identifier:
    NCT04647071
    Other Study ID Numbers:
    • C002
    First Posted:
    Nov 30, 2020
    Last Update Posted:
    May 23, 2022
    Last Verified:
    Nov 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by DOMCA S.A.
    Garlic
    Onion
    Immunity
    Additional relevant MeSH terms:
    Respiratory Tract Infections

    Study Results

    No Results Posted as of May 23, 2022