Allium Extracts on the Intestinal Microbiota in Healthy Resident Volunteers.

NCT ID: NCT05016999

Last Updated: 2023-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Intestinal Bacteria Flora Disturbance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
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.

Study Groups

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Control

Volunteers in this group will not take any products.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

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

Group Type EXPERIMENTAL

Garlic and onion concentrate

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Garlic and onion concentrate

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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AlioCare

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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DOMCA S.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carlos Gracián Alcaide, MD

Role: PRINCIPAL_INVESTIGATOR

Claret Residence for the Elderly (Granada, Spain).

Locations

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Residencia de Mayores Claret

Granada, , Spain

Site Status

Countries

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Spain

Other Identifiers

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C004

Identifier Type: -

Identifier Source: org_study_id

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