HypertensionENDOGARLICNCT04915053
Black Garlic Nutraceuticals and Blood Pressure Control
A study testing ABG+ Black Garlin and Crystalline Cellulose in people with Hypertension, run by Universitat de Lleida at 1 site in Spain.
Trial summary
Black garlic contains a series of allyl-sulfur compounds with the ability to modulate nitric oxide synthetase, angiotensin-converting enzyme system, and endothelial activation, which together could help better control blood pressure. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypertension
- What is being tested?
- ABG+ Black Garlin and Crystalline Cellulose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 15 May 2021to 30 Jun 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical hypertension, medically treated with no more than 2 drugs
Who cannot join
- Body mass index above 35 kg/m2
- Fasting blood cholesterol levels below 115 mg/dL
- Fasting blood glucose levels above 126 mg/dL
- Taking anyone of the Angiotensin-converting enzyme inhibitors
- Anemia (hemoglobin below 13 g/dL in men and below 12 g/dL in women)
- Vitamin or nutraceutical intake in the last 30 days before the study enrollment
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- Chronic gastrointestinal diseases
- Pregnancy and breastfeeding
- Garlic allergy
- Participation in another study 30 days before the study enrollment
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Arnau de Vilanova
Lleida, 25198
Macerlino S Bermudez, PhD, +34 973702482, mbermudez@irblleida.cat
Jose S Serrano Casasola, PhD, +34 973702408, josecarlos.serrano@udl.cat
About this study
Official title: Black Garlic Nutraceuticals Supplementation for the Control of Blood Pressure in Hypertension. A Triple-blind Randomized Placebo Control Study.
Black garlic contains a series of allyl-sulfur compounds with the ability to modulate nitric oxide synthetase, angiotensin-converting enzyme system, and endothelial activation, which together could help better control blood pressure. The main objective of this study is to evaluate the effect on blood pressure and endothelial health of a daily intake of a black garlic supplement named ABG (registered mark), which has a higher concentration of black garlic bioactive compounds, in people with moderate hypertension.
- Conditions
- Hypertension
- Being tested
- ABG+ Black Garlin, Crystalline Cellulose
- Keywords
- Garlic, Nitric oxide, Angiotensin-converting enzyme, Antioxidant capacity, Endothelial function
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABG+ Black GarlinDietary supplement
Daily tablet intake during three months
Crystalline CelluloseDietary supplement
Daily tablet intake during three months
| Study group | Role | What they receive |
|---|---|---|
| ABG Black Garlic Extract | Experimental | Daily intake of a 550 mg tablet, containing 250 mg of Black Garlic Extract and 300 mg of excipients. Receives: Dietary Supplement: ABG+ Black Garlin |
| Placebo | Placebo comparator | Daily intake of a 550 mg tablet, containing 250 mg of microcrystalline cellulose and 300 mg of excipients Receives: Dietary Supplement: Crystalline Cellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Blood Pressure
Indirect measure of blood pressure by a trained physician
Measured: Baseline and 12 weeks
Secondary outcomes (6)
Change in Blood nitric oxide content
Nitric oxide determined by nitrate and nitrite content in blood
Measured: Baseline and 12 weeks
Change in Angiotensin-converting enzyme activity
Activity measured by a substrate-enzyme activity kit
Measured: Baseline and 12 weeks
Change in Endothelial function
Endothelial blood flow capacity
Measured: Baseline and 12 weeks
Change in Blood lipid profile
Analysis of lipid profile (Total-cholesterol, LDL-cholesterol, Triacylglycerides, HDL-Cholesterol)
Measured: Baseline and 12 weeks
Change in Blood cytokine profile
Analysis of cytokine profile (TNFa, IL-1b, IL-18, IL-6, IL-8, IL-17, IL-23, TGFb) in blood by immunoassays (Multiplexed)
Measured: Baseline and 12 weeks
Change in Blood antioxidant capacity
Reduction capacity of blood determined by a biochemistry assay
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start15 May 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies 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
- Three measurements, initial, middle, and final.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat de Lleida
- Sponsor type
- University, hospital or other
- Collaborators
- Pharmactive Biotech Products S.L.U
- Responsible party
- Principal investigator, José Serrano, Universitat de Lleida
- Investigators
- Manuel S Portero, PhD, Principal investigator, Universitat de Lleida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04915053
- Sponsor's protocol ID
- CEIC-2435
- Acronym
- ENDOGARLIC
- Status last verified
- May 2021
- First submitted
- 24 May 2021
- Last updated
- 7 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD data will not be shared.
Publications
Serrano JCE, Castro-Boque E, Garcia-Carrasco A, Moran-Valero MI, Diez Municio M, Bermudez-Lopez M, Valdivielso JM, Espinel AE, Portero-Otin M. Effects of aged black garlic (ABG10+(R)) on lipoprotein subclass composition in Grade I hypertension: a randomized, triple-blind controlled trial with sex-stratified sequential allocation. Front Nutr. 2026 Jul 27;13:1869617. doi: 10.3389/fnut.2026.1869617. eCollection 2026.
PubMed 42577101
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Black Garlic Nutraceuticals Supplementation for the Control of Blood Pressure in Hypertension. A Triple-blind Randomized Placebo Control Study.
- ClinicalTrials.gov ID
- NCT04915053
- Acronym / sponsor ID
- ENDOGARLIC / CEIC-2435
- Conditions
- Hypertension
- Keywords
- Garlic, Nitric oxide, Angiotensin-converting enzyme, Antioxidant capacity, Endothelial function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universitat de LleidaUniversity, hospital or other
- Collaborators
- Pharmactive Biotech Products S.L.U
- Study start
- 15 May 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 7 Jun 2021 (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.
Black garlic contains a series of allyl-sulfur compounds with the ability to modulate nitric oxide synthetase, angiotensin-converting enzyme system, and endothelial activation, which together could help better control blood pressure. The main objective of this study is to evaluate the effect on blood pressure and endothelial health of a daily intake of a black garlic supplement named ABG (registered mark), which has a higher concentration of black garlic bioactive compounds, in people with moderate hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Three measurements, initial, middle, and final.
| Arm | Type | Receives |
|---|---|---|
| ABG Black Garlic Extract | Experimental | Dietary Supplement: ABG+ Black GarlinDaily intake of a 550 mg tablet, containing 250 mg of Black Garlic Extract and 300 mg of excipients. |
| Placebo | Placebo comparator | Dietary Supplement: Crystalline CelluloseDaily intake of a 550 mg tablet, containing 250 mg of microcrystalline cellulose and 300 mg of excipients |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical hypertension, medically treated with no more than 2 drugs
Key exclusion criteria (10 listed)
- Body mass index above 35 kg/m2
- Fasting blood cholesterol levels below 115 mg/dL
- Fasting blood glucose levels above 126 mg/dL
- Taking anyone of the Angiotensin-converting enzyme inhibitors
- Anemia (hemoglobin below 13 g/dL in men and below 12 g/dL in women)
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 |
|---|---|---|
| ABG+ Black GarlinDaily tablet intake during three months | Dietary supplement | ABG Black Garlic Extract |
| Crystalline CelluloseDaily tablet intake during three months | Dietary supplement | Placebo |
Primary outcome
Change in Blood Pressure
Time frame: Baseline and 12 weeks
Indirect measure of blood pressure by a trained physician
6 secondary outcomes
Change in Blood nitric oxide content
Time frame: Baseline and 12 weeks
Change in Angiotensin-converting enzyme activity
Time frame: Baseline and 12 weeks
Change in Endothelial function
Time frame: Baseline and 12 weeks
Change in Blood lipid profile
Time frame: Baseline and 12 weeks
Change in Blood cytokine profile
Time frame: Baseline and 12 weeks
Change in Blood antioxidant capacity
Time frame: Baseline and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2021.
- Derived from this study: PubMed 42577101Serrano JCE, Castro-Boque E, Garcia-Carrasco A, Moran-Valero MI, Diez Municio M, Bermudez-Lopez M, Valdivielso JM, Espinel AE, Portero-Otin M. Effects of aged black garlic (ABG10+(R)) on lipoprotein subclass composition in Grade I hypertension: a randomized, triple-blind controlled trial with sex-stratified sequential allocation. Front Nutr. 2026 Jul 27;13:1869617. doi: 10.3389/fnut.2026.1869617. eCollection 2026.
- Individual participant dataSharing planned: No. IPD data will not be shared.
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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.
Manuel S Portero, PhD principal investigator
Universitat de Lleida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ABG+ Black Garlin and Crystalline Cellulose in people with Hypertension, run by Universitat de Lleida 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 1 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 7 Jun 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcelino Bermúdez, PhD (+34 973702482, mbermudez@irblleida.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Blood Pressure (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04915053, which also lists 1 linked publication.
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 7 Jun 2021.