Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04646382
Recruitment Status : Recruiting
First Posted : November 30, 2020
Last Update Posted : August 20, 2021
Sponsor:
Information provided by (Responsible Party):
DOMCA S.A.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Cardiovascular Health Dietary Supplement: Garlic and onion concentrate Dietary Supplement: Control Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Controlled, randomized, double-blind, parallel group nutritional intervention study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

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".
Primary Purpose: Treatment
Official Title: Evaluation of the Effect of Consuming a Mixture of Concentrated Allium Extracts on LDL Cholesterol Levels in Healthy Volunteers With Elevated LDL Cholesterol Levels
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : March 29, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: AlioCare

Dietary Supplement: Control
Microcrystalline cellulose
Other Name: 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 Name: AlioCare

Dietary Supplement: Control
Microcrystalline cellulose
Other Name: Excipient


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. LDL [ Time Frame: 8 weeks. ]
    Serum LDL cholesterol


Secondary Outcome Measures :
  1. Cholesterol [ Time Frame: 8 weeks ]
    Serum total cholesterol

  2. HDL [ Time Frame: 8 weeks ]
    Serum HDL cholesterol

  3. Triglycerides [ Time Frame: 8 weeks ]
    Serum triglycerides

  4. Glucose [ Time Frame: 8 weeks ]
    Serum glucose

  5. CRP [ Time Frame: 8 weeks ]
    C-reactive protein in serum

  6. Oxidized LDL cholesterol [ Time Frame: 8 weeks ]
    Oxidized LDL cholesterol in plasma

  7. MDA [ Time Frame: 8 weeks ]
    Malondialdehyde in plasma

  8. TAC [ Time Frame: 8 weeks ]
    Plasma total antioxidant capacity

  9. Selenium [ Time Frame: 8 weeks ]
    Serun selenium

  10. Selenoprotein P [ Time Frame: 8 weeks ]
    Selenoprotein P in plasma

  11. VCAM-1 [ Time Frame: 8 weeks ]
    Endothelial adhesion molecules VCAM-1 in plasma

  12. ICAM-1 [ Time Frame: 8 weeks ]
    Endothelial adhesion molecules ICAM-1 in plasma

  13. IL1 beta in plasma [ Time Frame: 8 weeks ]
    Interleukin-1 beta in plasma

  14. IL 6 [ Time Frame: 8 weeks ]
    Interleukin-6 in plasma

  15. IL 10 [ Time Frame: 8 weeks ]
    Interleukin-10 in plasma

  16. BMI [ Time Frame: 8 weeks ]
    Body mass index (height/weight ratio)

  17. Abdominal perimeter [ Time Frame: 8 weeks ]
    Abdominal perimeter in centimeters

  18. Blood pressure [ Time Frame: 8 weeks ]
    Systolic pressure and diastolic pressure)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04646382


Contacts
Layout table for location contacts
Contact: Juristo Fonollá, PhD +34627354477 jfonolla@domca.com

Locations
Layout table for location information
Spain
Domca Sau Recruiting
Alhendín, Granada, Spain, 18620
Contact: Juristo Fonollá Joya, PhD       jfonolla@domca.com   
Sponsors and Collaborators
DOMCA S.A.
Investigators
Layout table for investigator information
Principal Investigator: Miguel Quesada, MD Endocrinology and Nutrition Clinic of Dr. Miguel Quesada
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: DOMCA S.A.
ClinicalTrials.gov Identifier: NCT04646382    
Other Study ID Numbers: C003
First Posted: November 30, 2020    Key Record Dates
Last Update Posted: August 20, 2021
Last Verified: November 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by DOMCA S.A.:
Garlic
Onion
LDL cholesterol
Cardiovascular health