Back to resultsAllium Extracts on the Incidence of Respiratory Infection Symptoms in Healthy Elderly Volunteers
Primary Purpose
Immunity
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Garlic and onion concentrate
Control
Sponsored by
About this trial
This is an interventional prevention trial for Immunity focused on measuring Garlic, Onion, Immunity
Eligibility Criteria
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.
Sites / Locations
- Residencia de Mayores Claret
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control
Intervention
Arm Description
Microcrystalline cellulose (9892- Capsules®) up to 400 mg.
Garlic concentrated extract plus onion concentrated extract plus microcrystalline cellulose (9892- Capsules®) up to 400 mg.
Outcomes
Primary Outcome Measures
Incidence of respiratory symptoms associated with infections.
It will be reviewed if the volunteer has had any symptoms related to respiratory diseases of infectious origin.
Secondary Outcome Measures
Duration of symptoms.
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.
If the volunteer has had any symptoms related to respiratory diseases of infectious origin, every 4 weeks treatment applied will be reviewed.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04647071
Brief Title
Allium Extracts on the Incidence of Respiratory Infection Symptoms in Healthy Elderly Volunteers
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
November 16, 2020 (Actual)
Primary Completion Date
July 26, 2021 (Actual)
Study Completion Date
January 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DOMCA S.A.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immunity
Keywords
Garlic, Onion, Immunity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Microcrystalline cellulose (9892- Capsules®) up to 400 mg.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Garlic concentrated extract plus onion concentrated extract plus microcrystalline cellulose (9892- Capsules®) up to 400 mg.
Intervention Type
Dietary Supplement
Intervention Name(s)
Garlic and onion concentrate
Other Intervention Name(s)
AlioCare
Intervention Description
Garlic extract concentrate (equivalent to 2 garlic cloves) and onion extract concentrate (equivalent to 1 onion).
Intervention Type
Dietary Supplement
Intervention Name(s)
Control
Other Intervention Name(s)
Excipient
Intervention Description
Microcrystalline cellulose
Primary Outcome Measure Information:
Title
Incidence of respiratory symptoms associated with infections.
Description
It will be reviewed if the volunteer has had any symptoms related to respiratory diseases of infectious origin.
Time Frame
36 weeks.
Secondary Outcome Measure Information:
Title
Duration of symptoms.
Description
If the volunteer has had any symptoms related to respiratory diseases of infectious origin, every 4 weeks duration of these symptoms will be reviewed.
Time Frame
36 weeks
Title
Consumption of medicines.
Description
If the volunteer has had any symptoms related to respiratory diseases of infectious origin, every 4 weeks treatment applied will be reviewed.
Time Frame
36 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Gracián, MD
Organizational Affiliation
Claret Residence for the Elderly (Granada, Spain).
Official's Role
Principal Investigator
Facility Information:
Facility Name
Residencia de Mayores Claret
City
Granada
ZIP/Postal Code
18012
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Allium Extracts on the Incidence of Respiratory Infection Symptoms in Healthy Elderly Volunteers
We'll reach out to this number within 24 hrs