Allium Extracts on the Intestinal Microbiota in Healthy Resident Volunteers.

Not Applicable

Completed

• Conditions: Intestinal Bacteria Flora Disturbance
• Interventions: Dietary Supplement: Garlic and onion concentrate

• Registration Number: NCT05016999
• Lead Sponsor: DOMCA S.A.

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.

Study Timeline

• Status Verified: 2021-08
• Study Start: 2021-08-01
• Study First Submitted: 2021-08-17
• Study First Submitted QC: 2021-08-17
• Study First Posted: 2021-08-23
• Primary Completion: 2022-06-15
• Study Completion: 2022-12-31
• Last Update Submitted: 2023-02-22
• Last Update Posted: 2023-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Garlic and onion concentrate	Garlic concentrated extract plus onion concentrated extract plus microcrystalline cellulose (9892- Capsules®) up to 400 mg.

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Residencia de Mayores Claret; 🇪🇸 Granada, Spain