Allium Extracts on the Intestinal Microbiota in Healthy Resident Volunteers.

Intestinal Bacteria Flora Disturbance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05016999
• Other study ID #: C004
• Status: Completed
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2021
• Source: DOMCA S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: December 31, 2022
• Est. primary completion date: June 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dysbiosis
• Intestinal Bacteria Flora Disturbance

Intervention

Dietary Supplement:
• Garlic and onion concentrate
Garlic extract concentrate (equivalent to 2 garlic cloves) and onion extract concentrate (equivalent to 1 onion)

Locations

Country	Name	City	State
Spain	Residencia de Mayores Claret	Granada

Sponsors (1)

Lead Sponsor	Collaborator
DOMCA S.A.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Events during 36 weeks.	Any health-related events that occurred during the study and their duration will be noted.	36 weeks
Secondary	Medication during 36 weeks.	The consumption of drugs during the study and its duration will be recorded.	36 weeks