NCT04646382

Brief Summary

To evaluate the efficacy of daily consumption of a combination of concentrated extracts of garlic (Allium sativum L.) and onion (Allium cepa L.) on LDL cholesterol levels in healthy volunteers. Parameters related to metabolic syndrome, cardiovascular health and the immune system will also be analyzed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 30, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

February 23, 2023

Status Verified

November 1, 2021

Enrollment Period

1.9 years

First QC Date

October 22, 2020

Last Update Submit

February 22, 2023

Conditions

Cardiovascular Health

Keywords

GarlicOnionLDL cholesterolCardiovascular health

Outcome Measures

Primary Outcomes (1)

  • LDL

    Serum LDL cholesterol

    8 weeks.

Study Arms (2)

Control

PLACEBO COMPARATOR

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

Dietary Supplement: Garlic and onion concentrateDietary Supplement: Control

Intervention

EXPERIMENTAL

Garlic concentrated extract. Onion concentrated extract. Microcrystalline cellulose (9892- Capsules®) up to 400 mg.

Dietary Supplement: Garlic and onion concentrateDietary Supplement: Control

Interventions

Garlic and onion concentrateDIETARY_SUPPLEMENT

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

Also known as: AlioCare
ControlIntervention
ControlDIETARY_SUPPLEMENT

Microcrystalline cellulose

Also known as: Excipient
ControlIntervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • LDL-cholesterol levels between 100 and 190 mg/dL.
  • Freely agree to participate in the study and sign the informed consent document.

You may not qualify if:

  • Be pregnant.
  • Have planned to change lifestyle and / or dietary habits.
  • Having diabetes.
  • Having a cerebrovascular disease.
  • Having a serious illness.
  • Taking products or drugs to control cholesterol levels or with antioxidant activity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Domca Sau

Alhendín, Granada, 18620, Spain

Location

MeSH Terms

Interventions

Excipients

Intervention Hierarchy (Ancestors)

Pharmaceutical VehiclesPharmaceutic AidsPharmaceutical PreparationsSpecialty Uses of ChemicalsChemical Actions and Uses

Study Officials

  • Miguel Quesada, MD

    Endocrinology and Nutrition Clinic of Dr. Miguel Quesada

    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".
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Controlled, randomized, double-blind, parallel group nutritional intervention study.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2020

First Posted

November 30, 2020

Study Start

February 1, 2021

Primary Completion

December 29, 2022

Study Completion

December 30, 2022

Last Updated

February 23, 2023

Record last verified: 2021-11

Locations

ES(1)