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Completed

NCT Number: NCT04646382

Effect of a Mixture of Allium Extracts on LDL Cholesterol Levels 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.

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Key information

Conditions

Cardiovascular Health

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Domca Sau

Alhendín, Granada, 18620, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Garlic and onion concentrate

Dietary Supplement

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

Other names: AlioCare

Control

Dietary Supplement

Microcrystalline cellulose

Other names: Excipient

Primary outcomes

  1. LDL

    Time frame: 8 weeks.

    Serum LDL cholesterol

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

DOMCA S.A.

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 30, 2020
Registry last updated
Feb 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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