- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04646382
Effect of a Mixture of Allium Extracts on LDL Cholesterol Levels Volunteers With Elevated LDL Cholesterol Levels
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 Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Juristo Fonollá, PhD
- Phone Number: +34627354477
- Email: jfonolla@domca.com
Study Locations
-
-
Granada
-
Alhendín, Granada, Spain, 18620
- Domca Sau
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Control
Microcrystalline cellulose (9892- Capsules®) up to 400 mg.
|
Garlic extract concentrate (equivalent to 2 garlic cloves) and onion extract concentrate (equivalent to 1 onion).
Other Names:
Microcrystalline cellulose
Other Names:
|
Experimental: Intervention
Garlic concentrated extract.
Onion concentrated extract.
Microcrystalline cellulose (9892- Capsules®) up to 400 mg.
|
Garlic extract concentrate (equivalent to 2 garlic cloves) and onion extract concentrate (equivalent to 1 onion).
Other Names:
Microcrystalline cellulose
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
LDL
Time Frame: 8 weeks.
|
Serum LDL cholesterol
|
8 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cholesterol
Time Frame: 8 weeks
|
Serum total cholesterol
|
8 weeks
|
HDL
Time Frame: 8 weeks
|
Serum HDL cholesterol
|
8 weeks
|
Triglycerides
Time Frame: 8 weeks
|
Serum triglycerides
|
8 weeks
|
Glucose
Time Frame: 8 weeks
|
Serum glucose
|
8 weeks
|
Time Frame: 8 weeks
|
Nitric oxide in serum
|
8 weeks
|
CRP
Time Frame: 8 weeks
|
C-reactive protein in serum
|
8 weeks
|
Oxidized LDL cholesterol
Time Frame: 8 weeks
|
Oxidized LDL cholesterol in plasma
|
8 weeks
|
MDA
Time Frame: 8 weeks
|
Malondialdehyde in plasma
|
8 weeks
|
TAC
Time Frame: 8 weeks
|
Plasma total antioxidant capacity
|
8 weeks
|
Selenium
Time Frame: 8 weeks
|
Serun selenium
|
8 weeks
|
Selenoprotein P
Time Frame: 8 weeks
|
Selenoprotein P in plasma
|
8 weeks
|
VCAM-1
Time Frame: 8 weeks
|
Endothelial adhesion molecules VCAM-1 in plasma
|
8 weeks
|
ICAM-1
Time Frame: 8 weeks
|
Endothelial adhesion molecules ICAM-1 in plasma
|
8 weeks
|
IL1 beta in plasma
Time Frame: 8 weeks
|
Interleukin-1 beta in plasma
|
8 weeks
|
IL 6
Time Frame: 8 weeks
|
Interleukin-6 in plasma
|
8 weeks
|
IL 10
Time Frame: 8 weeks
|
Interleukin-10 in plasma
|
8 weeks
|
BMI
Time Frame: 8 weeks
|
Body mass index (height/weight ratio)
|
8 weeks
|
Abdominal perimeter
Time Frame: 8 weeks
|
Abdominal perimeter in centimeters
|
8 weeks
|
Blood pressure
Time Frame: 8 weeks
|
Systolic pressure and diastolic pressure)
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Miguel Quesada, MD, Endocrinology and Nutrition Clinic of Dr. Miguel Quesada
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- C003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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