Allium Extracts on the Intestinal Microbiota in Healthy Resident Volunteers.

Study Overview
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Brief Summary
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To evaluate the effect of daily consumption of a combination of garlic and onion extracts on the intestinal microbiota and the production of short chain fatty acids in elderly healthy volunteers living in a residence. Likewise, any incident related to health that occurred during that period will be noted.

Detailed Description
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This study is a continuation of another (C002, registration number NCT04647071). 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.

Official Title
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Evaluation of the Effect of the Consumption of a Combination of Allium Extracts on the Intestinal Microbiota in Healthy Elderly Resident Volunteers. Preliminary Study.

Conditions
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Intestinal Bacteria Flora Disturbance

Intervention / Treatment
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* Dietary Supplement: Garlic and onion concentrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women aged 65 years or older who participated in study C002. 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: 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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Volunteers in this group will not take any products. | |
| Experimental: Intervention<br>Garlic concentrated extract plus onion concentrated extract plus microcrystalline cellulose (9892- Capsules®) up to 400 mg. | Dietary Supplement: Garlic and onion concentrate<br>* Garlic extract concentrate (equivalent to 2 garlic cloves) and onion extract concentrate (equivalent to 1 onion)<br>* Other names: AlioCare;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in bacterial species in feces. | The bacterial populations present in the stool samples taken at the beginning and at the end of the study will be studied. | 36 weeks. | 
| Short chain fatty acids in stool. | Short chain fatty acids present in stool samples taken at the beginning and end of the study will be studied. | 36 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Events during 36 weeks. | Any health-related events that occurred during the study and their duration will be noted. | 36 weeks | 
| Medication during 36 weeks. | The consumption of drugs during the study and its duration will be recorded. | 36 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Garlic, Onion, Microbiota