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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05016999
Other study ID # C004
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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