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OpenTrials
Completed

NCT Number: NCT05016999

Allium Extracts on the Intestinal Microbiota in Healthy Resident Volunteers.

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.

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Key information

Conditions

Intestinal Bacteria Flora Disturbance

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Residencia de Mayores Claret

Granada, 18012, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Garlic and onion concentrate

Dietary Supplement

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

Other names: AlioCare

Primary outcomes

  1. Changes in bacterial species in feces.

    Time frame: 36 weeks.

    The bacterial populations present in the stool samples taken at the beginning and at the end of the study will be studied.

  2. Short chain fatty acids in stool.

    Time frame: 36 weeks.

    Short chain fatty acids present in stool samples taken at the beginning and end of the study will be studied.

Secondary outcomes

  1. Events during 36 weeks.

    Time frame: 36 weeks

    Any health-related events that occurred during the study and their duration will be noted.

  2. Medication during 36 weeks.

    Time frame: 36 weeks

    The consumption of drugs during the study and its duration will be recorded.

Sponsors and collaborators

Lead sponsor

DOMCA S.A.

Industry

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 23, 2021
Registry last updated
Feb 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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