Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Volunteers in this group will not take any products. | |
| Intervention | Experimental | Garlic concentrated extract plus onion concentrated extract plus microcrystalline cellulose (9892- Capsules®) up to 400 mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Garlic and onion concentrate | Dietary Supplement | Garlic extract concentrate (equivalent to 2 garlic cloves) and onion extract concentrate (equivalent to 1 onion) |
|
| 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. |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Carlos Gracián Alcaide, MD | Claret Residence for the Elderly (Granada, Spain). | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Residencia de Mayores Claret | Granada | 18012 | Spain |
Not provided
Not provided
Not provided
Not provided
Each volunteer is assigned a "participant number" that is associated with the "pot number" that contains the product that the volunteer must take.
The "pot number" is the same as the "participant number". The pot does not indicate what product it is carrying.
|
| 36 weeks |