Allium Extracts on the Intestinal Microbiota in Healthy Resident Volunteers.
NCT ID: NCT05016999
Last Updated: 2023-02-23
Study Results
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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COMPLETED
NA
53 participants
INTERVENTIONAL
2021-08-01
2022-12-31
Brief Summary
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Likewise, any incident related to health that occurred during that period will be noted.
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Detailed Description
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The volunteers from study C002 were invited to participate in this new study and, by the end of C002, all gave 2 stool samples.
After 4 weeks of washout, the control group volunteers in C002 will begin consuming 1 capsule per day of garlic and onion extract after lunch. The intervention group volunteers in C002 will not consume anything.
During 36 weeks any incident related to the health of the volunteers will be noted. Likewise, during this time, the volunteers will maintain their lifestyle and eating habits.
At 36 weeks, 2 stool samples will be taken from all volunteers.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
TRIPLE
The "pot number" is the same as the "participant number". The pot does not indicate what product it is carrying.
Study Groups
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Control
Volunteers in this group will not take any products.
No interventions assigned to this group
Intervention
Garlic concentrated extract plus onion concentrated extract plus microcrystalline cellulose (9892- Capsules®) up to 400 mg.
Garlic and onion concentrate
Garlic extract concentrate (equivalent to 2 garlic cloves) and onion extract concentrate (equivalent to 1 onion)
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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 2\. Living in the Claret Residence for the Elderly in Granada during the study.
* 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
* Be unable to understand the study and sign voluntarily and freely the informed consent.
* Have a low expectation of compliance with the study protocol.
65 Years
ALL
Yes
Sponsors
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DOMCA S.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Carlos Gracián Alcaide, MD
Role: PRINCIPAL_INVESTIGATOR
Claret Residence for the Elderly (Granada, Spain).
Locations
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Residencia de Mayores Claret
Granada, , Spain
Countries
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Other Identifiers
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C004
Identifier Type: -
Identifier Source: org_study_id
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