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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04646382
Other study ID # C003
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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