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

Domca

Status: Completed

Conditions: Cardiovascular Health

Treatments: Dietary Supplement: Garlic and onion concentrate; Dietary Supplement: Control

Study type: Interventional

Funder types: Industry

Identifiers

NCT04646382

C003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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64 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Microcrystalline cellulose (9892- Capsules®) up to 400 mg.

Treatment:

Dietary Supplement: Control

Dietary Supplement: Garlic and onion concentrate

Intervention

Experimental group

Description:

Garlic concentrated extract. Onion concentrated extract. Microcrystalline cellulose (9892- Capsules®) up to 400 mg.

Treatment:

Dietary Supplement: Control

Dietary Supplement: Garlic and onion concentrate