ImmunityNCT04647071
Allium Extracts on the Incidence of Respiratory Infection Symptoms in Healthy Elderly Volunteers
A study testing Garlic and onion concentrate in people with Immunity, run by DOMCA S.A. at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Immunity
- What is being tested?
- Garlic and onion concentrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteSpain
- Study dates
- 16 Nov 2020to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Immunity
- Being tested
- Garlic and onion concentrate, Control
- Keywords
- Garlic, Onion, Immunity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Garlic and onion concentrateDietary supplement
Also called AlioCare
Garlic extract concentrate (equivalent to 2 garlic cloves) and onion extract concentrate (equivalent to 1 onion).
ControlDietary supplement
Also called Excipient
Microcrystalline cellulose
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Microcrystalline cellulose (9892- Capsules®) up to 400 mg. Receives: Dietary Supplement: Garlic and onion concentrate; Dietary Supplement: Control |
| Intervention | Experimental | Garlic concentrated extract plus onion concentrated extract plus microcrystalline cellulose (9892- Capsules®) up to 400 mg. Receives: Dietary Supplement: Garlic and onion concentrate; Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36 weeks.
Secondary outcomes (2)
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.
Measured: 36 weeks
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.
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2020
- Study start16 Nov 2020
- Primary completion26 Jul 2021
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- DOMCA S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carlos Gracián, MD, Principal investigator, Claret Residence for the Elderly (Granada, Spain).
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04647071
- Sponsor's protocol ID
- C002
- Status last verified
- Nov 2020
- First submitted
- 22 Oct 2020
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04647071
- Acronym / sponsor ID
- C002
- Conditions
- Immunity
- Keywords
- Garlic, Onion, Immunity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- DOMCA S.A.Industry (pharma, biotech, devices)
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 26 Jul 2021 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 30 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Dietary Supplement: Garlic and onion concentrate, Dietary Supplement: ControlMicrocrystalline cellulose (9892- Capsules®) up to 400 mg. |
| Intervention | Experimental | Dietary Supplement: Garlic and onion concentrate, Dietary Supplement: ControlGarlic concentrated extract plus onion concentrated extract plus microcrystalline cellulose (9892- Capsules®) up to 400 mg. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Garlic and onion concentrateAlso: AlioCareGarlic extract concentrate (equivalent to 2 garlic cloves) and onion extract concentrate (equivalent to 1 onion). | Dietary supplement | Control, Intervention |
| ControlAlso: ExcipientMicrocrystalline cellulose | Dietary supplement | Control, Intervention |
Primary outcome
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.
2 secondary outcomes
Duration of symptoms.
Time frame: 36 weeks
Consumption of medicines.
Time frame: 36 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Gracián, MD principal investigator
Claret Residence for the Elderly (Granada, Spain).
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Garlic and onion concentrate in people with Immunity, run by DOMCA S.A. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of respiratory symptoms associated with infections. (time frame: 36 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2022.