Allium Extracts on the Incidence of Respiratory Infection Symptoms in Healthy Elderly Volunteers

NCT04647071 | Completed

• 1 other identifier: C002
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

To analyze the efficacy of daily consumption of a combination of garlic and onion extracts on the incidence of respiratory infection symptoms in healthy elderly volunteers living in a residence. The duration of symptoms and related medication will also be studied.

Conditions

Immunity

Keywords

Garlic; Onion; Immunity

Outcome Measures

Primary Outcomes (1)

• Incidence of respiratory symptoms associated with infections.

  It will be reviewed if the volunteer has had any symptoms related to respiratory diseases of infectious origin.

  36 weeks.

Secondary Outcomes (2)

• Duration of symptoms.

  36 weeks

• Consumption of medicines.

  36 weeks

Study Arms (2)

Control

PLACEBO COMPARATOR

Microcrystalline cellulose (9892- Capsules®) up to 400 mg.

Dietary Supplement: Garlic and onion concentrate; Dietary Supplement: Control

Intervention

EXPERIMENTAL

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

Dietary Supplement: Garlic and onion concentrate; Dietary Supplement: Control

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

Control; Intervention

Control DIETARY_SUPPLEMENT

Microcrystalline cellulose

Also known as: Excipient

Control; Intervention

Eligibility Criteria

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

You may qualify if:

• Live in a nursing home with medical services.
• 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

MeSH Terms

Interventions

Excipients

Intervention Hierarchy (Ancestors)

Pharmaceutical Vehicles; Pharmaceutic Aids; Pharmaceutical Preparations; Specialty Uses of Chemicals; Chemical Actions and Uses

Study Officials

• Carlos Gracián, MD

  Claret Residence for the Elderly (Granada, Spain).

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Each volunteer is assigned a "participant number" that will be associated with a pot that will have all the product for the study. The "pot number" is the same as the "participant number". The pot does not indicate which product it is carrying.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: November 30, 2020
• Study Start: November 16, 2020
• Primary Completion: July 26, 2021
• Study Completion: January 31, 2022
• Last Updated: May 23, 2022

Record last verified: 2020-11

Locations

ES (1)