Cardiovascular DiseasesESACTIVONCT04010565
Effect of a Black Garlic Extract on Cholesterol LDL Levels
A study testing Aged black garlic extract in people with Cardiovascular Diseases, run by Technological Centre of Nutrition and Health, Spain at 1 site in Spain.
Trial summary
One of the most characteristic components of the Mediterranean diet is garlic (Allium sativum L.), food to which has been attributed protective properties against cardiovascular diseases (CVD). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Aged black garlic extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 1 siteSpain
- Study dates
- 24 Jul 2019to 19 Dec 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women over 18 years of age.
- Fasting serum LDL-c concentration ≥ 115 mg/dL.
- Sign the informed consent.
Who cannot join
- BMI ≥ 35 kg/m^2
- LDL-c serum levels <115 mg/dL
- Serum glucose levels higher than 126 mg/dL
- Take supplements or multivitamin supplements or phytotherapeutic products that interfere with the treatment under study up to 30 days before the start of the study.
- Be a smoker
- Follow a hypocaloric diet and/or pharmacological treatment for weight loss.
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- Anti-hypertensive treatment.
- Presenting anemia (hemoglobin ≤ 13 g/dL in men and ≤ 12 g/dL in women).
- Present some chronic gastrointestinal disease.
- Present some chronic disease in clinical manifestation.
- Being pregnant or intending to become pregnant.
- Be in breastfeeding period.
- Participate in or have participated in a clinical trial or nutritional intervention study in the last 30 days prior to inclusion in the study.
- Being unable to follow the study guidelines.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Centro Tecnológico de Nutrición y Salud (Eurecat-Reus)
Reus, Tarragona, 43203
About this study
Official title: Effect of a Black Garlic Extract With Greater Concentration of Bioactive Compounds and Lower Content in Undesired Compounds on Cholesterol LDL Levels. Chronic, Randomized, Crossover, Controled and Double Blind Study
One of the most characteristic components of the Mediterranean diet is garlic (Allium sativum L.), food to which has been attributed protective properties against cardiovascular diseases (CVD). Recently, several methods of garlic processing have been developed to obtain derivatives with milder organoleptic characteristics and a longer shelf life than habitual garlic derivates. One of these strategies is the aging of the garlic by high temperatures treatment that eliminates the taste and characteristic odor of garlic and gives it a dark color, a sweet taste and a slimy texture. Because the changes in the visual and organoleptic characteristics, the garlic obtained by aging at high temperatures is named black garlic.
Interestingly, these modifications translate into an increase in their antioxidant power and their protective capacity against the development of CVDs, mainly due to the formation of melanoidins and to the content of organosulfur derivatives of cysteine compounds, such as S-allyl-cysteine (SAC) and alliin.
Read more
Hypothesis of the study: The daily administration of a new extract of aged black garlic (SANE), with a higher concentration of bioactive compounds and lower unwanted compounds will lower cholesterol levels of low density lipoproteins (LDL-c), and will produce favorable changes on other markers of cardiovascular risk in individuals with moderate hypercholesterolemia.
Each 250 mg of SANE contains 0.5% in SAC, which will mean an amount of 1.25 mg of SAC per day, about 5 times more than SAC levels present in many of the black garlic products marketed.
The main objective was to evaluate the effect of the daily intake of a SANE with a higher concentration of bioactive compounds, SAC and alliin, and minor unwanted compounds such as simple sugars and furfural derivatives, in combination with dietary recommendations, on LDL-c levels in individuals with moderate hypercholesterolemia.
Read the detailed description
Chronic, randomized, crossover, placebo-controlled and double-blind nutritional intervention trial.
The 60 participants in the study will be randomly divided into two groups of 30 participants, as they begin the study taking the SANE or placebo for 6 weeks.
At the end of study week 6, when the first treatment is finished, a 3-week washout period will be carried out, and then the treatment that will take place during another 6 weeks will be exchanged. Total study duration of 15 weeks.
The dose of SANE will be 250 mg daily, presented in a tablet of 550 mg / unit. The placebo will be microcrystalline cellulose. The consumption of SANE and placebo will be in the form of tablets with the same appearance, of 550 mg / tablet, guaranteeing that the study is blind both for the researchers of the project and for the participants (double blind).
The tablets will be presented in recipients of 45 units, so that with one recipient the participants will be able to carry out the entire intervention for each of the products.
Adverse effects will be controlled: body odor, halitosis, flatulence, nausea, abdominal distension, reflux and allergic reactions.
During the study, volunteers will perform 7 visits, according to the cross-type study design.
- a pre-selection visit (to check inclusion / exclusion criteria) (V0) and, in case of meeting the inclusion criteria,
- three study visits during the consumption of SANE, which will take place in weeks 1 (start of the study), 3 and 6 (end point) (V1, V2, V3).
- three study visits during the consumption of the placebo, which will take place in weeks 1 (start of the study), 3 and 6 (end point) (V4, V5, V6).
In all the visits the participants must present themselves in fasting conditions of 8 hours to obtain blood. In addition, at each visit (except in the case of V0) a questionnaire will be conducted to determine the presence / absence of adverse effects.
Main variable: LDL-c concentrations.
Secondary variables:
- Measures of body composition (in all study visits, V0-V6):
- Body weight.
- Height.
- Body mass index (BMI) (Kg / m2).
- Waist circumference.
- Blood pressure (in all study visits, V0-V6):
- Systolic blood pressure (SBP).
- Diastolic blood pressure (DBP).
- Parameters in plasma:
- Total cholesterol, High density lipoproteins cholesterol (HDL-c) and triglycerides (TG) (in all study visits, V0-V6).
- From these values the atherogenic indices (AIs) will be calculated:
- Total cholesterol / HDL-c;
- LDL-c / HDL-c
- Plasma atherogenic index, which combines the values of triglycerides and HDL-c, calculated as the logarithm of the TG / HDL-c ratio, which is considered a good indirect indicator of the size of the LDL-c particles and of the subclinical atherosclerosis.
- Glucose (in all the visits of the study, V0-V6).
- Insulin and Non esterified free fatty acids (NEFAs) (at the beginning and end of the study period visits with each of the two products (SANE or placebo).
- From the glucose and insulin values, the Homeostatic Model Assessment for insulin resistance index (HOMA-IR) and the revised-Quantitative insulin sensitivity index (R-QUICKI) will be calculated.
- The pro-inflammatory cytokines Monocyte chemoattractant protein 1 (MCP-1), Interleukin 6 (IL-6) and (Tumor necrosis factor alpha (TNF-α) (at the beginning and end of the study period visits with each of the two products (SANE or placebo).
- Apolipoprotein (Apo) B, a protein present in the potentially atherogenic particles present in plasma and that reflects the number of particles that contain cholesterol and triglycerides (in the visits of the beginning and end of the study period with each of the two products (SANE or placebo).
- Apo A1, the major protein present in HDL-c and that initiates the reverse transport of cholesterol (in the visits of the beginning and end of the study period with each of the two products (SANE or placebo).
- Based on the ApoB and ApoA1 values, the Apo B / Apo A1 ratio will be calculated as an indicator of cardiovascular disease risk. This ratio reflects the balance between proatherogenic and CVD protective particles.
- Oxidized LDL-c (oxLDL) (at the beginning and end of the study period visits with each of the two products (SANE or placebo).
- Phospholipid transfer protein (PLTP) (at the start and end visits of the study period with each of the two products (SANE or placebo).
- Conditions
- Cardiovascular Diseases
- Being tested
- Aged black garlic extract, Placebo
- Keywords
- Cholesterol LDL, Black garlic extract, S-allyl cysteine
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aged black garlic extractDietary supplement
Participants will intake a tablet with 250 mg of a aged black garlic extract with higher concentration of bioactive compounds S-allyl cysteine and alliin, and minor unwanted compounds such as simple sugars and furfural derivatives.
In addition, during the course of the study, participants will be urged to follow dietary guidelines according to a heart-healthy diet established by nutritionists and that they will adhere to European guidelines for the treatment of dyslipidemias.
PlaceboDietary supplement
Participants will intake a tablet with 250 mg of microcrystalline cellulose. In addition, during the course of the study, participants will be urged to follow dietary guidelines according to a heart-healthy diet established by nutritionists and that they will adhere to European guidelines for the treatment of dyslipidemias.
| Study group | Role | What they receive |
|---|---|---|
| Extract of aged black garlic | Experimental | Participants will consume a tablet of 550 mg daily with 250 mg of aged black garlic extract and 300 mg of excipients (microcrystaline cellulose 90 mg; dicalcium phosphate 157 mg; crosscamellose sodium 10 mg; magnesium stearate 7 mg; sodium alignate 3.06 mg; stearic acid 0.03 mg; oleic acid 1.54 mg; medium chain triglycerides 2.80 mg; ethylcellulose 13.17 mg; hydroxypropylcellulose 4.86 mg; hydroxypropylmethylcellulose 4.86 mg; talcum 2.88 mg; titanium dioxide 1.80 mg; vanilla aroma 1.00 mg) . Receives: Dietary Supplement: Aged black garlic extract |
| Placebo | Placebo comparator | Participants will consume a tablet of 550 mg daily with 550 mg of excipients (microcrystaline cellulose 342.5 mg; dicalcium phosphate 154.5 mg; crosscamellose sodium 10 mg; magnesium stearate 7 mg; sodium alignate 3.06 mg; stearic acid 0.03 mg; oleic acid 1.54 mg; medium chain triglycerides 2.80 mg; ethylcellulose 13.17 mg; hydroxypropylcellulose 4.86 mg; hydroxypropylmethylcellulose 4.86 mg; talcum 2.88 mg; titanium dioxide 1.80 mg; vanilla aroma 1.00 mg). Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-c levels
Serum LDL-c levels will be measured by standardized methods in Cobas Mira Plus autoanalyzer (Roche Diagnostics Systems, Madrid, Spain).
Measured: At week 1, week 3 and week 6 for each of the two treatments (SANE and placebo).
Secondary outcomes (8)
Measures of body weight
Body weight measured by TANITA SC330.
Measured: At week 1, week 3 and week 6 for each of the two treatments (SANE and placebo).
Measures of height
Height measured by standardized methods.
Measured: At week 1, week 3 and week 6 for each of the two treatments (SANE and placebo).
Measures of BMI
Weight and height will be combined to report BMI in kg/m^2.
Measured: At week 1 for each of the two treatments (SANE and placebo).
Measures of waist circumference
Waist circumference using a measuring tape.
Measured: At week 1, week 3 and week 6 for each of the two treatments (SANE and placebo).
Bood pressure (measured in mmHg)
Systolic and diastolic blood pressure will be measured twice after 2-5 minutes of patient respite, seated, with one-minute interval in between, using an automatic sphygmomanometer (OMRON HEM-907; Peroxfarma, Barcelona, Spain).
Measured: At week 1, week 3 and week 6 for each of the two treatments (SANE and placebo).
Lipid metabolism
Total cholesterol, HDL-c, TG, NEFAs, Apo B and Apo A1 plasma levels will be measured by standardized methods in Cobas Mira Plus autoanalyzer (Roche Diagnostics Systems, Madrid, Spain). oxLDL, PLTP plasma levels will be measured by human ELISA kits.
Measured: At week 1, week 3 and week 6 for each of the two treatments (SANE and placebo).
Glucose metabolism
Glucose and insulin plasma levels will be measured by standardized methods in Cobas Mira Plus autoanalyzer (Roche Diagnostics Systems, Madrid, Spain).
Measured: At week 1, week 3 and week 6 for each of the two treatments (SANE and placebo).
Inflammation
IL-6 plasma levels will be measured by standardized methods in Cobas Mira Plus autoanalyzer (Roche Diagnostics Systems, Madrid, Spain). MCP-1 and TNF alpha will be measured by human ELISA kits.
Measured: At week 1, week 3 and week 6 for each of the two treatments (SANE and placebo).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start24 Jul 2019
- Primary completion19 Dec 2019
- Study completion19 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technological Centre of Nutrition and Health, Spain
- Sponsor type
- University, hospital or other
- Collaborators
- Fundació Eurecat, Hospital Universitari Sant Joan de Reus, University Rovira i Virgili, Pharmactive Biotech Products S.L.U
- Responsible party
- Sponsor
- Investigators
- Rosa Solà, Dr, Principal investigator, Centro Tecnológico de Nutrición y Salud (Eurecat_Reus). Reus, Tarragona, Spain.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04010565
- Sponsor's protocol ID
- ESACTIVO
- Acronym
- ESACTIVO
- Status last verified
- Feb 2022
- First submitted
- 3 Jul 2019
- Last updated
- 28 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Black Garlic Extract With Greater Concentration of Bioactive Compounds and Lower Content in Undesired Compounds on Cholesterol LDL Levels. Chronic, Randomized, Crossover, Controled and Double Blind Study
- ClinicalTrials.gov ID
- NCT04010565
- Acronym / sponsor ID
- ESACTIVO / ESACTIVO
- Conditions
- Cardiovascular Diseases
- Keywords
- Cholesterol LDL, Black garlic extract, S-allyl cysteine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Technological Centre of Nutrition and Health, SpainUniversity, hospital or other
- Collaborators
- Fundació Eurecat, Hospital Universitari Sant Joan de Reus, University Rovira i Virgili, Pharmactive Biotech Products S.L.U
- Study start
- 24 Jul 2019 (actual)
- Primary completion
- 19 Dec 2019 (actual)
- Study completion
- 19 Dec 2019 (actual)
- First posted
- 8 Jul 2019 (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.
One of the most characteristic components of the Mediterranean diet is garlic (Allium sativum L.), food to which has been attributed protective properties against cardiovascular diseases (CVD). Recently, several methods of garlic processing have been developed to obtain derivatives with milder organoleptic characteristics and a longer shelf life than habitual garlic derivates. One of these strategies is the aging of the garlic by high temperatures treatment that eliminates the taste and characteristic odor of garlic and gives it a dark color, a sweet taste and a slimy texture. Because the changes in the visual and organoleptic characteristics, the garlic obtained by aging at high temperatures is named black garlic.
Interestingly, these modifications translate into an increase in their antioxidant power and their protective capacity against the development of CVDs, mainly due to the formation of melanoidins and to the content of organosulfur derivatives of cysteine compounds, such as S-allyl-cysteine (SAC) and alliin.
Hypothesis of the study: The daily administration of a new extract of aged black garlic (SANE), with a higher concentration of bioactive compounds and lower unwanted compounds will lower cholesterol levels of low density lipoproteins (LDL-c), and will produce favorable changes on other markers of cardiovascular risk in individuals with moderate hypercholesterolemia.
Each 250 mg of SANE contains 0.5% in SAC, which will mean an amount of 1.25 mg of SAC per day, about 5 times more than SAC levels present in many of the black garlic products marketed.
The main objective was to evaluate the effect of the daily intake of a SANE with a higher concentration of bioactive compounds, SAC and alliin, and minor unwanted compounds such as simple sugars and furfural derivatives, in combination with dietary recommendations, on LDL-c levels in individuals with moderate hypercholesterolemia.
Detailed description
Chronic, randomized, crossover, placebo-controlled and double-blind nutritional intervention trial.
The 60 participants in the study will be randomly divided into two groups of 30 participants, as they begin the study taking the SANE or placebo for 6 weeks.
At the end of study week 6, when the first treatment is finished, a 3-week washout period will be carried out, and then the treatment that will take place during another 6 weeks will be exchanged. Total study duration of 15 weeks.
The dose of SANE will be 250 mg daily, presented in a tablet of 550 mg / unit. The placebo will be microcrystalline cellulose. The consumption of SANE and placebo will be in the form of tablets with the same appearance, of 550 mg / tablet, guaranteeing that the study is blind both for the researchers of the project and for the participants (double blind).
The tablets will be presented in recipients of 45 units, so that with one recipient the participants will be able to carry out the entire intervention for each of the products.
Adverse effects will be controlled: body odor, halitosis, flatulence, nausea, abdominal distension, reflux and allergic reactions.
During the study, volunteers will perform 7 visits, according to the cross-type study design.
- a pre-selection visit (to check inclusion / exclusion criteria) (V0) and, in case of meeting the inclusion criteria,
- three study visits during the consumption of SANE, which will take place in weeks 1 (start of the study), 3 and 6 (end point) (V1, V2, V3).
- three study visits during the consumption of the placebo, which will take place in weeks 1 (start of the study), 3 and 6 (end point) (V4, V5, V6).
In all the visits the participants must present themselves in fasting conditions of 8 hours to obtain blood. In addition, at each visit (except in the case of V0) a questionnaire will be conducted to determine the presence / absence of adverse effects.
Main variable: LDL-c concentrations.
Secondary variables:
- Measures of body composition (in all study visits, V0-V6):
- Body weight.
- Height.
- Body mass index (BMI) (Kg / m2).
- Waist circumference.
- Blood pressure (in all study visits, V0-V6):
- Systolic blood pressure (SBP).
- Diastolic blood pressure (DBP).
- Parameters in plasma:
- Total cholesterol, High density lipoproteins cholesterol (HDL-c) and triglycerides (TG) (in all study visits, V0-V6).
- From these values the atherogenic indices (AIs) will be calculated:
- Total cholesterol / HDL-c;
- LDL-c / HDL-c
- Plasma atherogenic index, which combines the values of triglycerides and HDL-c, calculated as the logarithm of the TG / HDL-c ratio, which is considered a good indirect indicator of the size of the LDL-c particles and of the subclinical atherosclerosis.
- Glucose (in all the visits of the study, V0-V6).
- Insulin and Non esterified free fatty acids (NEFAs) (at the beginning and end of the study period visits with each of the two products (SANE or placebo).
- From the glucose and insulin values, the Homeostatic Model Assessment for insulin resistance index (HOMA-IR) and the revised-Quantitative insulin sensitivity index (R-QUICKI) will be calculated.
- The pro-inflammatory cytokines Monocyte chemoattractant protein 1 (MCP-1), Interleukin 6 (IL-6) and (Tumor necrosis factor alpha (TNF-α) (at the beginning and end of the study period visits with each of the two products (SANE or placebo).
- Apolipoprotein (Apo) B, a protein present in the potentially atherogenic particles present in plasma and that reflects the number of particles that contain cholesterol and triglycerides (in the visits of the beginning and end of the study period with each of the two products (SANE or placebo).
- Apo A1, the major protein present in HDL-c and that initiates the reverse transport of cholesterol (in the visits of the beginning and end of the study period with each of the two products (SANE or placebo).
- Based on the ApoB and ApoA1 values, the Apo B / Apo A1 ratio will be calculated as an indicator of cardiovascular disease risk. This ratio reflects the balance between proatherogenic and CVD protective particles.
- Oxidized LDL-c (oxLDL) (at the beginning and end of the study period visits with each of the two products (SANE or placebo).
- Phospholipid transfer protein (PLTP) (at the start and end visits of the study period with each of the two products (SANE or placebo).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extract of aged black garlic | Experimental | Dietary Supplement: Aged black garlic extractParticipants will consume a tablet of 550 mg daily with 250 mg of aged black garlic extract and 300 mg of excipients (microcrystaline cellulose 90 mg; dicalcium phosphate 157 mg; crosscamellose sodium 10 mg; magnesium stearate 7 mg; sodium alignate 3.06 mg; stearic acid 0.03 mg; oleic acid 1.54 mg; medium chain triglycerides 2.80 mg; ethylcellulose 13.17 mg; hydroxypropylcellulose 4.86 mg; hydroxypropylmethylcellulose 4.86 mg; talcum 2.88 mg; titanium dioxide 1.80 mg; vanilla aroma 1.00 mg) . |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants will consume a tablet of 550 mg daily with 550 mg of excipients (microcrystaline cellulose 342.5 mg; dicalcium phosphate 154.5 mg; crosscamellose sodium 10 mg; magnesium stearate 7 mg; sodium alignate 3.06 mg; stearic acid 0.03 mg; oleic acid 1.54 mg; medium chain triglycerides 2.80 mg; ethylcellulose 13.17 mg; hydroxypropylcellulose 4.86 mg; hydroxypropylmethylcellulose 4.86 mg; talcum 2.88 mg; titanium dioxide 1.80 mg; vanilla aroma 1.00 mg). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women over 18 years of age.
- Fasting serum LDL-c concentration ≥ 115 mg/dL.
- Sign the informed consent.
Key exclusion criteria (14 listed)
- BMI ≥ 35 kg/m^2
- LDL-c serum levels <115 mg/dL
- Serum glucose levels higher than 126 mg/dL
- Take supplements or multivitamin supplements or phytotherapeutic products that interfere with the treatment under study up to 30 days before the start of the study.
- Be a smoker
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 |
|---|---|---|
| Aged black garlic extractParticipants will intake a tablet with 250 mg of a aged black garlic extract with higher concentration of bioactive compounds S-allyl cysteine and alliin, and minor unwanted compounds such as simple sugars and furfural derivatives. In addition, during the course of the study, participants will be urged to follow dietary guidelines according to a heart-healthy diet established by nutritionists and that they will adhere to European guidelines for the treatment of dyslipidemias. | Dietary supplement | Extract of aged black garlic |
| PlaceboParticipants will intake a tablet with 250 mg of microcrystalline cellulose. In addition, during the course of the study, participants will be urged to follow dietary guidelines according to a heart-healthy diet established by nutritionists and that they will adhere to European guidelines for the treatment of dyslipidemias. | Dietary supplement | Placebo |
Primary outcome
LDL-c levels
Time frame: At week 1, week 3 and week 6 for each of the two treatments (SANE and placebo).
Serum LDL-c levels will be measured by standardized methods in Cobas Mira Plus autoanalyzer (Roche Diagnostics Systems, Madrid, Spain).
8 secondary outcomes
Measures of body weight
Time frame: At week 1, week 3 and week 6 for each of the two treatments (SANE and placebo).
Measures of height
Time frame: At week 1, week 3 and week 6 for each of the two treatments (SANE and placebo).
Measures of BMI
Time frame: At week 1 for each of the two treatments (SANE and placebo).
Measures of waist circumference
Time frame: At week 1, week 3 and week 6 for each of the two treatments (SANE and placebo).
Bood pressure (measured in mmHg)
Time frame: At week 1, week 3 and week 6 for each of the two treatments (SANE and placebo).
Lipid metabolism
Time frame: At week 1, week 3 and week 6 for each of the two treatments (SANE and placebo).
Glucose metabolism
Time frame: At week 1, week 3 and week 6 for each of the two treatments (SANE and placebo).
Inflammation
Time frame: At week 1, week 3 and week 6 for each of the two treatments (SANE and placebo).
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 28 Feb 2022.
- Technological Centre of Nutrition and Health. Eurecat\_Reus.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Rosa Solà, Dr principal investigator
Centro Tecnológico de Nutrición y Salud (Eurecat_Reus). Reus, Tarragona, Spain.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aged black garlic extract in people with Cardiovascular Diseases, run by Technological Centre of Nutrition and Health, Spain 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 3 inclusion and 14 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 28 Feb 2022. 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-c levels (time frame: At week 1, week 3 and week 6 for each of the two treatments (SANE and placebo).). 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 28 Feb 2022.