HypertensionGARDOSENCT06264622
ABG+/GarlACE Effects on Cardiovascular Risk Factors in Subjects With Grade I Hypertension
A study testing Low dose and High dose in people with Hypertension, run by Universitat de Lleida at 1 site in Spain.
Trial summary
The goal of this clinical trial is to evaluate the dose response effect on cardiovascular disease risk factors of a Black Garlic Extract in subjects with Grade I Hypertension. The main questions it aims to answer are: If the reduction in blood pressure (systolic and diastolic) is in a dose-response manner If the… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Low dose and High dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteSpain
- Study dates
- 26 Feb 2024to 31 Dec 2024
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women with Grade I Hypertension (systolic blood pressure between 130 and 139 mmHg; and diastolic blood pressure between 80 to 89 mmHg) without taking any antihypertensive drug
Who cannot join
- Acute or chronic kidney disease including dyslipidemia due to nephrotic syndrome.- -
- Hypothyroidism
- Having previously suffered a myocardial infarction or stroke
- Pharmacological treatment with insulin, sulfonylureas, protease inhibitors
- Chronic gastrointestinal disease
- Pregnancy or intention to become pregnant during the study period.
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- Breastfeeding
- Allergy or intolerance to garlic
- High alcohol consumption (>14 units per week)
- Smokers
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
University of Lleida
Lleida, 25198
Jose Serrano, PhD, 973702408, josecarlos.serrano@udl.cat
Manuel Portero, PhD, 973702408, manuel.portero@udl.cat
About this study
Official title: Dose Response Study of the Effects of a Daily Supplementation With a Black Garlic Extract, ABG+/GarlACE on Cardiovascular Disease Risk Factors in Subjects With Grade I Hypertension
The goal of this clinical trial is to evaluate the dose response effect on cardiovascular disease risk factors of a Black Garlic Extract in subjects with Grade I Hypertension. The main questions it aims to answer are:
- If the reduction in blood pressure (systolic and diastolic) is in a dose-response manner
- If the changes in lipid profile are in a dose-response manner
Participants will be randomly assign to a low dose (250 mg/day), high dose (600 mg/day) or placebo of a standardized Garlic Extract (ABG+/GarlACE) during 12 weeks
- Conditions
- Hypertension
- Being tested
- Low dose, High dose, Placebo
- Keywords
- Grade I Hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low doseDietary supplement
2 tablets per day during the morning for 12 weeks.
High doseDietary supplement
2 tablets per day during the morning for 12 weeks.
PlaceboDietary supplement
2 tablets per day during the morning for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Low Dose | Experimental | 250 mg/day of Garlic Extract Receives: Dietary Supplement: Low dose |
| High Dose | Experimental | 600 mg/day of Garlic Extract Receives: Dietary Supplement: High dose |
| Placebo | Placebo comparator | Placebo tablets Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
Upper arm blood pressure (Systolic and Diastolic)
Measured: Pre-treatment and 12 weeks post-treatment
Secondary outcomes (1)
Blood Lipid Profile
Blood lipid profile including total cholesterol, LDL-cholesterol, HDL-cholesterol and triacylglycerides
Measured: Pre-treatment and 12 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start26 Feb 2024 (estimated)
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Dec 2024 (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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06264622
- Sponsor's protocol ID
- CEIC-2996
- Acronym
- GARDOSE
- Status last verified
- Feb 2024
- First submitted
- 9 Feb 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be available to other researchers. Group data could be asked by demand
Publications
Serrano JCE, Castro-Boque E, Garcia-Carrasco A, Moran-Valero MI, Gonzalez-Hedstrom D, Bermudez-Lopez M, Valdivielso JM, Espinel AE, Portero-Otin M. Antihypertensive Effects of an Optimized Aged Garlic Extract in Subjects with Grade I Hypertension and Antihypertensive Drug Therapy: A Randomized, Triple-Blind Controlled Trial. Nutrients. 2023 Aug 23;15(17):3691. doi: 10.3390/nu15173691.
PubMed 37686723
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Response Study of the Effects of a Daily Supplementation With a Black Garlic Extract, ABG+/GarlACE on Cardiovascular Disease Risk Factors in Subjects With Grade I Hypertension
- ClinicalTrials.gov ID
- NCT06264622
- Acronym / sponsor ID
- GARDOSE / CEIC-2996
- Conditions
- Hypertension
- Keywords
- Grade I Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Universitat de LleidaUniversity, hospital or other
- Collaborators
- Pharmactive Biotech Products S.L.U
- Study start
- 26 Feb 2024 (estimated)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 20 Feb 2024 (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.
The goal of this clinical trial is to evaluate the dose response effect on cardiovascular disease risk factors of a Black Garlic Extract in subjects with Grade I Hypertension. The main questions it aims to answer are:
- If the reduction in blood pressure (systolic and diastolic) is in a dose-response manner
- If the changes in lipid profile are in a dose-response manner
Participants will be randomly assign to a low dose (250 mg/day), high dose (600 mg/day) or placebo of a standardized Garlic Extract (ABG+/GarlACE) during 12 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Dose | Experimental | Dietary Supplement: Low dose250 mg/day of Garlic Extract |
| High Dose | Experimental | Dietary Supplement: High dose600 mg/day of Garlic Extract |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo tablets |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men and women with Grade I Hypertension (systolic blood pressure between 130 and 139 mmHg; and diastolic blood pressure between 80 to 89 mmHg) without taking any antihypertensive drug
Key exclusion criteria (10 listed)
- Acute or chronic kidney disease including dyslipidemia due to nephrotic syndrome.- -
- Hypothyroidism
- Having previously suffered a myocardial infarction or stroke
- Pharmacological treatment with insulin, sulfonylureas, protease inhibitors
- Chronic gastrointestinal disease
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 |
|---|---|---|
| Low dose2 tablets per day during the morning for 12 weeks. | Dietary supplement | Low Dose |
| High dose2 tablets per day during the morning for 12 weeks. | Dietary supplement | High Dose |
| Placebo2 tablets per day during the morning for 12 weeks. | Dietary supplement | Placebo |
Primary outcome
Blood Pressure
Time frame: Pre-treatment and 12 weeks post-treatment
Upper arm blood pressure (Systolic and Diastolic)
1 secondary outcome
Blood Lipid Profile
Time frame: Pre-treatment and 12 weeks post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Results publication: PubMed 37686723Serrano JCE, Castro-Boque E, Garcia-Carrasco A, Moran-Valero MI, Gonzalez-Hedstrom D, Bermudez-Lopez M, Valdivielso JM, Espinel AE, Portero-Otin M. Antihypertensive Effects of an Optimized Aged Garlic Extract in Subjects with Grade I Hypertension and Antihypertensive Drug Therapy: A Randomized, Triple-Blind Controlled Trial. Nutrients. 2023 Aug 23;15(17):3691. doi: 10.3390/nu15173691.
- Individual participant dataSharing planned: No. No individual participant data will be available to other researchers. Group data could be asked by demand
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low dose and High dose 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 20 Feb 2024. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure (time frame: Pre-treatment and 12 weeks post-treatment). 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 NCT06264622, 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 20 Feb 2024.