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Allium Extracts on the Intestinal Microbiota in Healthy Resident Volunteers.

D

Domca

Status

Completed

Conditions

Intestinal Bacteria Flora Disturbance

Treatments

Dietary Supplement: Garlic and onion concentrate

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

53 patients

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Men and women aged 65 years or older who participated in study C002.
    1. 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.

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

53 participants in 2 patient groups

Control
No Intervention group
Description:
Volunteers in this group will not take any products.
Intervention
Experimental group
Description:
Garlic concentrated extract plus onion concentrated extract plus microcrystalline cellulose (9892- Capsules®) up to 400 mg.
Treatment:
Dietary Supplement: Garlic and onion concentrate

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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