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

Cardiovascular Health Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04646382
• Other study ID #: C003
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: November 2021
• Source: DOMCA S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 30, 2022
• Est. primary completion date: December 29, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Health

Intervention

Dietary Supplement:
• Garlic and onion concentrate
Garlic extract concentrate (equivalent to 2 garlic cloves) and onion extract concentrate (equivalent to 1 onion).
• Control
Microcrystalline cellulose

Locations

Country	Name	City	State
Spain	Domca Sau	Alhendín	Granada

Sponsors (1)

Lead Sponsor	Collaborator
DOMCA S.A.

Country where clinical trial is conducted

Spain, 

Outcome

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