Clinical trial NCT04646382: Effect of a Mixture of Allium Extracts on LDL Cholesterol Levels Volunteers With Elevated LDL Cholesterol Levels
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Health
Keywords: Garlic
Onion
LDL cholesterol
Cardiovascular health
Lead sponsor: DOMCA S.A.
Sponsor class: INDUSTRY
First posted: 2020-11-30
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Controlled, randomized, double-blind, parallel group nutritional intervention study.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: LDL
timeFrame: 8 weeks.
Secondary outcomes:
measure: Cholesterol
timeFrame: 8 weeks
measure: HDL
timeFrame: 8 weeks
measure: Triglycerides
timeFrame: 8 weeks
measure: Glucose
timeFrame: 8 weeks
timeFrame: 8 weeks
measure: CRP
timeFrame: 8 weeks
measure: Oxidized LDL cholesterol
timeFrame: 8 weeks
measure: MDA
timeFrame: 8 weeks
measure: TAC
timeFrame: 8 weeks
measure: Selenium
timeFrame: 8 weeks
measure: Selenoprotein P
timeFrame: 8 weeks
measure: VCAM-1
timeFrame: 8 weeks
measure: ICAM-1
timeFrame: 8 weeks
measure: IL1 beta in plasma
timeFrame: 8 weeks
measure: IL 6
timeFrame: 8 weeks
measure: IL 10
timeFrame: 8 weeks
measure: BMI
timeFrame: 8 weeks
measure: Abdominal perimeter
timeFrame: 8 weeks
measure: Blood pressure
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Alhendín
country: Spain
facility: Domca Sau
state: Granada
Study officials:
affiliation: Endocrinology and Nutrition Clinic of Dr. Miguel Quesada
name: Miguel Quesada, MD
role: PRINCIPAL_INVESTIGATOR
References: