Intestinal Bacteria Flora Disturbance
Conditions
Keywords
Garlic, Onion, Microbiota
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTGarlic and onion concentrate
Garlic extract concentrate (equivalent to 2 garlic cloves) and onion extract concentrate (equivalent to 1 onion)
Sponsors
DOMCA S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in bacterial species in feces. | 36 weeks. | The bacterial populations present in the stool samples taken at the beginning and at the end of the study will be studied. |
| Short chain fatty acids in stool. | 36 weeks. | Short chain fatty acids present in stool samples taken at the beginning and end of the study will be studied. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Events during 36 weeks. | 36 weeks | Any health-related events that occurred during the study and their duration will be noted. |
| Medication during 36 weeks. | 36 weeks | The consumption of drugs during the study and its duration will be recorded. |
Countries
Spain
Outcome results
None listed