Cardiovascular HealthNCT04646382
Effect of a Mixture of Allium Extracts on LDL Cholesterol Levels Volunteers With Elevated LDL Cholesterol Levels
A study testing Garlic and onion concentrate in people with Cardiovascular Health, run by DOMCA S.A. at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Health
- What is being tested?
- Garlic and onion concentrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2021to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- LDL-cholesterol levels between 100 and 190 mg/dL.
- Freely agree to participate in the study and sign the informed consent document.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Cardiovascular Health
- Being tested
- Garlic and onion concentrate, Control
- Keywords
- Garlic, Onion, LDL cholesterol, Cardiovascular health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Garlic and onion concentrateDietary supplement
Also called AlioCare
Garlic extract concentrate (equivalent to 2 garlic cloves) and onion extract concentrate (equivalent to 1 onion).
ControlDietary supplement
Also called Excipient
Microcrystalline cellulose
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Microcrystalline cellulose (9892- Capsules®) up to 400 mg. Receives: Dietary Supplement: Garlic and onion concentrate; Dietary Supplement: Control |
| Intervention | Experimental | Garlic concentrated extract. Onion concentrated extract. Microcrystalline cellulose (9892- Capsules®) up to 400 mg. Receives: Dietary Supplement: Garlic and onion concentrate; Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL
Serum LDL cholesterol
Measured: 8 weeks.
Secondary outcomes (19)
Cholesterol
Serum total cholesterol
Measured: 8 weeks
HDL
Serum HDL cholesterol
Measured: 8 weeks
Triglycerides
Serum triglycerides
Measured: 8 weeks
Glucose
Serum glucose
Measured: 8 weeks
Nitric oxide in serum
Measured: 8 weeks
CRP
C-reactive protein in serum
Measured: 8 weeks
Oxidized LDL cholesterol
Oxidized LDL cholesterol in plasma
Measured: 8 weeks
MDA
Malondialdehyde in plasma
Measured: 8 weeks
TAC
Plasma total antioxidant capacity
Measured: 8 weeks
Selenium
Serun selenium
Measured: 8 weeks
Selenoprotein P
Selenoprotein P in plasma
Measured: 8 weeks
VCAM-1
Endothelial adhesion molecules VCAM-1 in plasma
Measured: 8 weeks
ICAM-1
Endothelial adhesion molecules ICAM-1 in plasma
Measured: 8 weeks
IL1 beta in plasma
Interleukin-1 beta in plasma
Measured: 8 weeks
IL 6
Interleukin-6 in plasma
Measured: 8 weeks
IL 10
Interleukin-10 in plasma
Measured: 8 weeks
BMI
Body mass index (height/weight ratio)
Measured: 8 weeks
Abdominal perimeter
Abdominal perimeter in centimeters
Measured: 8 weeks
Blood pressure
Systolic pressure and diastolic pressure)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2020
- Study start1 Feb 2021
- Primary completion29 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Controlled, randomized, double-blind, parallel group nutritional intervention study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- DOMCA S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Miguel Quesada, MD, Principal investigator, Endocrinology and Nutrition Clinic of Dr. Miguel Quesada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04646382
- Sponsor's protocol ID
- C003
- Status last verified
- Nov 2021
- First submitted
- 22 Oct 2020
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04646382
- Acronym / sponsor ID
- C003
- Conditions
- Cardiovascular Health
- Keywords
- Garlic, Onion, LDL cholesterol, Cardiovascular health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- DOMCA S.A.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 29 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 30 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Controlled, randomized, double-blind, parallel group nutritional intervention study.
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Dietary Supplement: Garlic and onion concentrate, Dietary Supplement: ControlMicrocrystalline cellulose (9892- Capsules®) up to 400 mg. |
| Intervention | Experimental | Dietary Supplement: Garlic and onion concentrate, Dietary Supplement: ControlGarlic concentrated extract. Onion concentrated extract. Microcrystalline cellulose (9892- Capsules®) up to 400 mg. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- LDL-cholesterol levels between 100 and 190 mg/dL.
- Freely agree to participate in the study and sign the informed consent document.
Key exclusion criteria (6 listed)
- Be pregnant.
- Have planned to change lifestyle and / or dietary habits.
- Having diabetes.
- Having a cerebrovascular disease.
- Having a serious illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Garlic and onion concentrateAlso: AlioCareGarlic extract concentrate (equivalent to 2 garlic cloves) and onion extract concentrate (equivalent to 1 onion). | Dietary supplement | Control, Intervention |
| ControlAlso: ExcipientMicrocrystalline cellulose | Dietary supplement | Control, Intervention |
Primary outcome
LDL
Time frame: 8 weeks.
Serum LDL cholesterol
19 secondary outcomes
Cholesterol
Time frame: 8 weeks
HDL
Time frame: 8 weeks
Triglycerides
Time frame: 8 weeks
Glucose
Time frame: 8 weeks
Time frame: 8 weeks
CRP
Time frame: 8 weeks
Oxidized LDL cholesterol
Time frame: 8 weeks
MDA
Time frame: 8 weeks
TAC
Time frame: 8 weeks
Selenium
Time frame: 8 weeks
Selenoprotein P
Time frame: 8 weeks
VCAM-1
Time frame: 8 weeks
ICAM-1
Time frame: 8 weeks
IL1 beta in plasma
Time frame: 8 weeks
IL 6
Time frame: 8 weeks
IL 10
Time frame: 8 weeks
BMI
Time frame: 8 weeks
Abdominal perimeter
Time frame: 8 weeks
Blood pressure
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miguel Quesada, MD principal investigator
Endocrinology and Nutrition Clinic of Dr. Miguel Quesada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Garlic and onion concentrate in people with Cardiovascular Health, run by DOMCA S.A. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LDL (time frame: 8 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2023.