Back to resultsAllium Extracts on the Intestinal Microbiota in Healthy Resident Volunteers.
Primary Purpose
Intestinal Bacteria Flora Disturbance
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Garlic and onion concentrate
Sponsored by
About this trial
This is an interventional screening trial for Intestinal Bacteria Flora Disturbance focused on measuring Garlic, Onion, Microbiota
Eligibility Criteria
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.
Sites / Locations
- Residencia de Mayores Claret
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Intervention
Arm Description
Volunteers in this group will not take any products.
Garlic concentrated extract plus onion concentrated extract plus microcrystalline cellulose (9892- Capsules®) up to 400 mg.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Events during 36 weeks.
Any health-related events that occurred during the study and their duration will be noted.
Medication during 36 weeks.
The consumption of drugs during the study and its duration will be recorded.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05016999
Brief Title
Allium Extracts on the Intestinal Microbiota in Healthy Resident Volunteers.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
June 15, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DOMCA S.A.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intestinal Bacteria Flora Disturbance
Keywords
Garlic, Onion, Microbiota
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes 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.
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Volunteers in this group will not take any products.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Garlic concentrated extract plus onion concentrated extract plus microcrystalline cellulose (9892- Capsules®) up to 400 mg.
Intervention Type
Dietary Supplement
Intervention Name(s)
Garlic and onion concentrate
Other Intervention Name(s)
AlioCare
Intervention Description
Garlic extract concentrate (equivalent to 2 garlic cloves) and onion extract concentrate (equivalent to 1 onion)
Primary Outcome Measure Information:
Title
Changes in bacterial species in feces.
Description
The bacterial populations present in the stool samples taken at the beginning and at the end of the study will be studied.
Time Frame
36 weeks.
Title
Short chain fatty acids in stool.
Description
Short chain fatty acids present in stool samples taken at the beginning and end of the study will be studied.
Time Frame
36 weeks.
Secondary Outcome Measure Information:
Title
Events during 36 weeks.
Description
Any health-related events that occurred during the study and their duration will be noted.
Time Frame
36 weeks
Title
Medication during 36 weeks.
Description
The consumption of drugs during the study and its duration will be recorded.
Time Frame
36 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Gracián Alcaide, MD
Organizational Affiliation
Claret Residence for the Elderly (Granada, Spain).
Official's Role
Principal Investigator
Facility Information:
Facility Name
Residencia de Mayores Claret
City
Granada
ZIP/Postal Code
18012
Country
Spain
12. IPD Sharing Statement
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Allium Extracts on the Intestinal Microbiota in Healthy Resident Volunteers.
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