Allium Extracts on the Intestinal Microbiota in Healthy Resident Volunteers.

NCT05016999 | Completed

• 1 other identifier: C004
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Intestinal Bacteria Flora Disturbance

Keywords

Garlic; Onion; Microbiota

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (2)

• Events during 36 weeks.

  36 weeks

• Medication during 36 weeks.

  36 weeks

Study Arms (2)

Control

NO INTERVENTION

Volunteers in this group will not take any products.

Intervention

EXPERIMENTAL

Garlic concentrated extract plus onion concentrated extract plus microcrystalline cellulose (9892- Capsules®) up to 400 mg.

Dietary Supplement: Garlic and onion concentrate

Interventions

Garlic and onion concentrate DIETARY_SUPPLEMENT

Garlic extract concentrate (equivalent to 2 garlic cloves) and onion extract concentrate (equivalent to 1 onion)

Also known as: AlioCare

Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Men and women aged 65 years or older who participated in study C002.
• \. 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• DOMCA S.A.: lead

Study Sites (1)

Residencia de Mayores Claret

Granada, 18012, Spain

Location

Study Officials

• Carlos Gracián Alcaide, MD

  Claret Residence for the Elderly (Granada, Spain).

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: August 23, 2021
• Study Start: August 1, 2021
• Primary Completion: June 15, 2022
• Study Completion: December 31, 2022
• Last Updated: February 23, 2023

Record last verified: 2021-08

Locations

ES (1)