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

Not Applicable

Completed

• Conditions: Cardiovascular Health
• Interventions: Dietary Supplement: Garlic and onion concentrate; Dietary Supplement: Control

• Registration Number: NCT04646382
• Lead Sponsor: DOMCA S.A.

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.

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 Timeline

• Study First Submitted: 2020-10-22
• Study First Submitted QC: 2020-11-27
• Study First Posted: 2020-11-30
• Study Start: 2021-02-01
• Status Verified: 2021-11
• Primary Completion: 2022-12-29
• Study Completion: 2022-12-30
• Last Update Submitted: 2023-02-22
• Last Update Posted: 2023-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	Microcrystalline cellulose (9892- Capsules®) up to 400 mg.
Control	Garlic and onion concentrate	Microcrystalline cellulose (9892- Capsules®) up to 400 mg.
Intervention	Garlic and onion concentrate	Garlic concentrated extract. Onion concentrated extract. Microcrystalline cellulose (9892- Capsules®) up to 400 mg.
Intervention	Control	Garlic concentrated extract. Onion concentrated extract. Microcrystalline cellulose (9892- Capsules®) up to 400 mg.

Primary Outcome Measures

Name	Time	Method
LDL	8 weeks.	Serum LDL cholesterol

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Domca Sau; 🇪🇸 Alhendín, Granada, Spain