Effect of a Mixture of Allium Extracts on LDL Cholesterol Levels Volunteers With Elevated LDL Cholesterol Levels

February 22, 2023 updated by: DOMCA S.A.

Evaluation of the Effect of Consuming a Mixture of Concentrated Allium Extracts on LDL Cholesterol Levels in Healthy Volunteers With Elevated LDL Cholesterol Levels

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

It is a controlled, randomized, double-blind, parallel-group nutritional intervention study.

64 healthy volunteers lwith elevated LDL cholesterol levels but who do not require pharmacological treatment will be randomly distributed into 2 equal groups: control group and intervention group.

For 8 weeks the volunteers will take the product immediately after lunch. During that time they will maintain their lifestyle and nutritional habits.

Blood samples will be taken at 0, 2, 4 and 8 weeks. Anthropometric parameters and health-related data were also measured.

Parameters related to lipid metabolism, metabolic syndrome and the immune system will be analized.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Granada
      • Alhendín, Granada, Spain, 18620
        • Domca Sau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
Microcrystalline cellulose (9892- Capsules®) up to 400 mg.
Dietary supplement: Garlic and onion concentrate
Garlic extract concentrate (equivalent to 2 garlic cloves) and onion extract concentrate (equivalent to 1 onion).
Other Names:
  • AlioCare
Dietary supplement: Control
Microcrystalline cellulose
Other Names:
  • Excipient
Experimental: Intervention
Garlic concentrated extract. Onion concentrated extract. Microcrystalline cellulose (9892- Capsules®) up to 400 mg.
Dietary supplement: Garlic and onion concentrate
Garlic extract concentrate (equivalent to 2 garlic cloves) and onion extract concentrate (equivalent to 1 onion).
Other Names:
  • AlioCare
Dietary supplement: Control
Microcrystalline cellulose
Other Names:
  • Excipient

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LDL
Time Frame: 8 weeks.
Serum LDL cholesterol
8 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cholesterol
Time Frame: 8 weeks
Serum total cholesterol
8 weeks
HDL
Time Frame: 8 weeks
Serum HDL cholesterol
8 weeks
Triglycerides
Time Frame: 8 weeks
Serum triglycerides
8 weeks
Glucose
Time Frame: 8 weeks
Serum glucose
8 weeks
Time Frame: 8 weeks
Nitric oxide in serum
8 weeks
CRP
Time Frame: 8 weeks
C-reactive protein in serum
8 weeks
Oxidized LDL cholesterol
Time Frame: 8 weeks
Oxidized LDL cholesterol in plasma
8 weeks
MDA
Time Frame: 8 weeks
Malondialdehyde in plasma
8 weeks
TAC
Time Frame: 8 weeks
Plasma total antioxidant capacity
8 weeks
Selenium
Time Frame: 8 weeks
Serun selenium
8 weeks
Selenoprotein P
Time Frame: 8 weeks
Selenoprotein P in plasma
8 weeks
VCAM-1
Time Frame: 8 weeks
Endothelial adhesion molecules VCAM-1 in plasma
8 weeks
ICAM-1
Time Frame: 8 weeks
Endothelial adhesion molecules ICAM-1 in plasma
8 weeks
IL1 beta in plasma
Time Frame: 8 weeks
Interleukin-1 beta in plasma
8 weeks
IL 6
Time Frame: 8 weeks
Interleukin-6 in plasma
8 weeks
IL 10
Time Frame: 8 weeks
Interleukin-10 in plasma
8 weeks
BMI
Time Frame: 8 weeks
Body mass index (height/weight ratio)
8 weeks
Abdominal perimeter
Time Frame: 8 weeks
Abdominal perimeter in centimeters
8 weeks
Blood pressure
Time Frame: 8 weeks
Systolic pressure and diastolic pressure)
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DOMCA S.A.

Investigators

  • Principal Investigator: Miguel Quesada, MD, Endocrinology and Nutrition Clinic of Dr. Miguel Quesada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Actual)

December 29, 2022

Study Completion (Actual)

December 30, 2022

Study Registration Dates

First Submitted

October 22, 2020

First Submitted That Met QC Criteria

November 27, 2020

First Posted (Actual)

November 30, 2020

Study Record Updates

Last Update Posted (Estimate)

February 23, 2023

Last Update Submitted That Met QC Criteria

February 22, 2023

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • C003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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