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OpenTrials
Completed

NCT Number: NCT04647071

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

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.

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Key information

Conditions

Immunity

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Residencia de Mayores Claret

Granada, 18012, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Garlic and onion concentrate

Dietary Supplement

Garlic extract concentrate (equivalent to 2 garlic cloves) and onion extract concentrate (equivalent to 1 onion).

Other names: AlioCare

Control

Dietary Supplement

Microcrystalline cellulose

Other names: Excipient

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

DOMCA S.A.

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Nov 30, 2020
Registry last updated
May 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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