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

NCT ID: NCT04647071

Last Updated: 2022-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-16

Study Completion Date

2022-01-31

Brief Summary

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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

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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.

Conditions

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Immunity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

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Control

Microcrystalline cellulose (9892- Capsules®) up to 400 mg.

Group Type PLACEBO_COMPARATOR

Garlic and onion concentrate

Intervention Type DIETARY_SUPPLEMENT

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

Control

Intervention Type DIETARY_SUPPLEMENT

Microcrystalline cellulose

Intervention

Garlic concentrated extract plus onion concentrated extract plus microcrystalline cellulose (9892- Capsules®) up to 400 mg.

Group Type EXPERIMENTAL

Garlic and onion concentrate

Intervention Type DIETARY_SUPPLEMENT

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

Control

Intervention Type DIETARY_SUPPLEMENT

Microcrystalline cellulose

Interventions

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Garlic and onion concentrate

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

Intervention Type DIETARY_SUPPLEMENT

Control

Microcrystalline cellulose

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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AlioCare Excipient

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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DOMCA S.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carlos Gracián, MD

Role: PRINCIPAL_INVESTIGATOR

Claret Residence for the Elderly (Granada, Spain).

Locations

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Residencia de Mayores Claret

Granada, , Spain

Site Status

Countries

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Spain

Other Identifiers

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C002

Identifier Type: -

Identifier Source: org_study_id

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