Cardiovascular DiseasesHYPERGRAPESNCT04992936
Effect of an Extract From the Wine Industry on Blood Pressure (HYPERGRAPES)
A study testing Extract from the wine industry in people with Cardiovascular Diseases and Hypertension, run by Fundació Eurecat at 1 site in Spain.
Trial summary
By-products from the wine industry pose serious problems of management, both from an economic and environmental point of view. Although traditionally the use of by-products of the wine sector has been limited to the production of biogas and energy, or its use as animal feed or agricultural fertilizer, there is greater… 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, Hypertension
- What is being tested?
- Extract from the wine industry
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteSpain
- Study dates
- 26 Aug 2021to 22 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 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.
- Systolic blood pressure between 130- 159 mm Hg.
- Not under pharmacological treatment or have completed pharmacological treatment at least one month before the start of the study with anti-hypertensive and/or with lipid-lowering drugs. 2. Sign the informed consent.
Who cannot join
- BMI ≥ 35 kg/m^2.
- Have a clinical history of chronic kidney disease, cardiovascular disease and/or cancer.
- Be a smoker or ex-smoker in the last 6 months before inclusion in the study.
- Present diabetes.
- Take supplements with polyphenol components or aimed to lipid or blood pressure control during their participation in the study.
- Take 2 or more Standard Beverage Units daily or 17 weekly for women, or take 4 or more Standard Beverage Units daily or 28 weekly for men.
Show all 12Show fewer
- Present some chronic gastrointestinal disease.
- Present food intolerances and/or allergies related to the products of the study, such as hypersensitivity to maltodextrin and/or sulfites.
- Being pregnant or intending to become pregnant.
- Be in breastfeeding period.
- Participate in or have participated in a clinical trial with drugs 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.
About this study
Official title: Effect of an Alcohol-Free Extract From the Wine Industry on Blood Pressure in Individuals With High Blood Pressure and Grade 1 Hypertension. Randomized, Crossover, Controlled Double Blind Study
By-products from the wine industry pose serious problems of management, both from an economic and environmental point of view. Although traditionally the use of by-products of the wine sector has been limited to the production of biogas and energy, or its use as animal feed or agricultural fertilizer, there is greater interest in the use of these by-products as a potential source of functional ingredients.
Cardiovascular diseases (CVD) are the main cause of mortality in Europe, with hypertension being one of the main CVD risk factors. It has been shown that lowering blood pressure through behavioral and pharmacological interventions significantly improves CVD. Currently, one of the most widely used pharmacological therapies to treat hypertension is based on the use of angiotensin converting enzyme (ACE) inhibitors such as Captopril or Enalapril. ACE plays a key role in arterial pressure regulation, catalyzing the production of angiotensin II, an octapeptide with potent vasoconstrictor activity. In addition, ACE catalyzes the inactivation of bradykinin, peptide with vasodilator activity. The evaluation of various potential by-products of the wine industry for the generation of functional ingredients showed that an extract from the wine industry presented beneficial effects on blood pressure in in vitro models as well as in vivo models using rats with hypertension.
Read the detailed description
The main objective of the study is to evaluate the effect of daily intake of an extract from the wine industry on the change in systolic blood pressure values in individuals with high blood pressure and grade 1 hypertension.
Secondary objectives are to evaluate the effects of an extract from the wine industry on:
- The change in diastolic blood pressure values.
- The change in body weight, body mass index (BMI) and waist circumference.
- The change in the circulating values of total cholesterol, LDL-c, HDL-c, triglycerides and ApoB.
- The change in the atherogenic index of plasma, which combines triglycerides and HDL-c values and which is considered a good indirect indicator of LDL-c particle size and subclinical atherosclerosis.
- Glucose metabolism and insulin resistance.
- The change in the inflammation values analyzed by the marker high sensitivity C-reactive protein.
Study Design: Randomized, crossover, placebo-controlled and double-blind nutritional intervention trial.
The number of subjects in the study will be 40. After the pre-screening visit, the participants will be randomly divided into two groups of 20 participants, according to start the study by taking the extract from the wine industry or placebo for 5 weeks. At the end of the week 5 of the study, when the first treatment is finished, there will be a washing period for 3 weeks and then the treatment will be changed for another 5 weeks: a total of 14 weeks.
The containers of the two treatments, the extract from the wine industry and the placebo, will present the same shape and appearance. The two products will present similar organoleptic characteristics of taste and color.
Each volunteer will make 5 visits, according to the crossover study design:
- a pre-selection visit (to check inclusion / exclusion criteria) (V0; week1) and, in case of meeting the inclusion criteria,
- two study visits during the consumption of the first product (extract from the wine industry or placebo), which will take place on the first day of study (V1; week 2) and after 5 weeks of treatment (V2; week 7).
- two study visits during the consumption of the second product (extract from the wine industry or placebo), which will take place after the three week washout period (V3; week 10) and after 5 weeks of treatment (V4; week 15).
In all visits except the V0 visit, participants must present themselves in fasting conditions of 8 hours to obtain blood. In addition, on V2 visits and V4 the participants will be asked the presence / absence of adverse effects that could be associated with the consumption of the study products.
Main variable: Systolic blood pressure levels.
Secondary variables:
- Diastolic blood pressure levels.
- Body weight.
- Height.
- Body mass index (BMI) (Kg/m2).
- Waist circumference.
- Conicity index.
- Waist circumference/Height ratio.
- Parameters in serum:
- Glucose.
- Insulin.
- Homeostatic Model Assessment for insulin resistance index (HOMA-IR).
- Total cholesterol.
- High density lipoproteins cholesterol (HDL-c).
- Low density lipoproteins cholesterol (LDL-c).
- Triglycerides (TG).
- Atherogenic indices:
- Total cholesterol/HDL-c
- LDL-c/HDL-c
- Plasma atherogenic index, calculated as the logarithm of the TG/HDL-c ratio.
- Apolipoprotein (apo) B.
- C-reactive protein.
- Faecal intestinal microbiota composition.
- Physical activity record.
- Record of potential adverse events.
- Frequency of consumption of supplements to avoid in the study.
- Completion of the intervention.
- Conditions
- Cardiovascular Diseases, Hypertension
- Being tested
- Extract from the wine industry, Placebo
- Keywords
- Blood pressure, wine, by-products
- Medical subject headings
- Cardiovascular Diseases, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extract from the wine industryDietary supplement
The product will be presented in powder format in a single container and with a measuring spoon of the daily dose.
PlaceboDietary supplement
The product will be presented in powder format in a single container and with a measuring spoon of the daily dose.
| Study group | Role | What they receive |
|---|---|---|
| Extract from the wine industry | Experimental | Participants will consume the extract from the wine industry for 5 weeks. Receives: Dietary Supplement: Extract from the wine industry |
| Placebo | Placebo comparator | Participants will consume maltodextrin for 5 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systolic blood pressure
Systolic blood pressure will be measured using an automatic sphygmomanometer.
Measured: Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).
Secondary outcomes (22)
Change in diastolic blood pressure
Diastolic blood pressure will be measured using an automatic sphygmomanometer.
Measured: Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).
Change in body weight
Body weight measured by standardized method.
Measured: Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).
Height
Height measured by standardized method.
Measured: At week 1.
Change in BMI
Weight and height will be combined to report BMI in kg/m^2.
Measured: Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).
Changes in waist circumference
Waist circumference using a measuring tape.
Measured: Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).
Changes in conicity index
Weight, height and waist circumference will be combined to report Conicity index.
Measured: Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).
Changes in waist circumference to height ratio
Waist circumference and height will be combined to report Waist circumference to Height ratio.
Measured: Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).
Changes in serum glucose levels
Serum glucose levels will be measured by standardized ultraviolet-visible spectrophotometry methods.
Measured: Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).
Changes in serum insulin levels
Serum insulin levels will be measured by standardized chemiluminescence methods.
Measured: Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).
Changes in Homeostatic Model Assessment from Insulin Resistance Index (HOMA-IR)
HOMA-IR will be calculated using serum glucose and insulin levels.
Measured: Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).
Changes in serum total cholesterol levels.
Serum total cholesterol levels will be measured by standardized ultraviolet-visible spectrophotometry methods.
Measured: Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).
Changes in serum HDL-c levels.
Serum HDL-c levels will be measured by standardized ultraviolet-visible spectrophotometry methods.
Measured: Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).
Changes in serum LDL-c levels.
Serum LDL-c levels will be calculated using the Friedewald formula.
Measured: Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).
Changes in serum Triglycerides levels
Serum triglycerides levels will be measured by standardized ultraviolet-visible spectrophotometry methods.
Measured: Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).
Changes in total cholesterol to HDL-c ratio
Total cholesterol and HDL-c values will be combined to report Total cholesterol to HDL-c ratio.
Measured: Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).
Changes in LDL-c to HDL-c ratio
LDL-c and HDL-c values will be combined to report LDL-c to HDL-c ratio.
Measured: Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).
Changes in Plasma atherogenic index
Plasma atherogenic index will be calculated as the logarithm of the TG to HDL-c ratio.
Measured: Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).
Changes in serum Apo B levels
Serum Apo B levels will be measured by standardized turbidimetry methods.
Measured: Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).
Changes in serum C- Reactive protein levels
Serum C-Reactive protein levels will be measured by standardized turbidimetry methods.
Measured: Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).
Changes in intestinal microbiota composition
Metagenomic analysis in fecal samples. The bacteria DNA will be extracted and massive sequenced by the Ion Torrent platform.
Measured: Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).
Change in Physical activity
Physical activity will be evaluated through the International Physical Activity. Questionnaire (IPAQ)-short for physical activity questionnaire. The questionnaire asks about three specific types of activity (walking, moderate-intensity activities and vigorous intensity activities) in the set domains leisure time, domestic and gardening (yard) activities, work-related and transport-related activities. Frequency and duration are collected separately for each specific type of activity.
Measured: Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).
Adverse events
Possible adverse events derived from taking study's products will be recorded.
Measured: Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start26 Aug 2021
- Primary completion22 Jun 2022
- Study completion22 Jun 2022
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
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundació Eurecat
- Sponsor type
- University, hospital or other
- Collaborators
- University Rovira i Virgili, Grandes Vinos y Viñedos S.A.
- Responsible party
- Sponsor
- Investigators
- Josep M Del Bas, PhD, Principal investigator, UTNS (Eurecat-Reus)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04992936
- Sponsor's protocol ID
- HYPERGRAPES
- Acronym
- HYPERGRAPES
- Status last verified
- Mar 2023
- First submitted
- 24 Jul 2021
- Last updated
- 16 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared with the Universitat Rovira i Virgili for the intestinal microbiota composition analysis
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Alcohol-Free Extract From the Wine Industry on Blood Pressure in Individuals With High Blood Pressure and Grade 1 Hypertension. Randomized, Crossover, Controlled Double Blind Study
- ClinicalTrials.gov ID
- NCT04992936
- Acronym / sponsor ID
- HYPERGRAPES / HYPERGRAPES
- Conditions
- Cardiovascular Diseases, Hypertension
- Keywords
- Blood pressure, wine, by-products
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Fundació EurecatUniversity, hospital or other
- Collaborators
- University Rovira i Virgili, Grandes Vinos y Viñedos S.A.
- Study start
- 26 Aug 2021 (actual)
- Primary completion
- 22 Jun 2022 (actual)
- Study completion
- 22 Jun 2022 (actual)
- First posted
- 5 Aug 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.
By-products from the wine industry pose serious problems of management, both from an economic and environmental point of view. Although traditionally the use of by-products of the wine sector has been limited to the production of biogas and energy, or its use as animal feed or agricultural fertilizer, there is greater interest in the use of these by-products as a potential source of functional ingredients.
Cardiovascular diseases (CVD) are the main cause of mortality in Europe, with hypertension being one of the main CVD risk factors. It has been shown that lowering blood pressure through behavioral and pharmacological interventions significantly improves CVD. Currently, one of the most widely used pharmacological therapies to treat hypertension is based on the use of angiotensin converting enzyme (ACE) inhibitors such as Captopril or Enalapril. ACE plays a key role in arterial pressure regulation, catalyzing the production of angiotensin II, an octapeptide with potent vasoconstrictor activity. In addition, ACE catalyzes the inactivation of bradykinin, peptide with vasodilator activity. The evaluation of various potential by-products of the wine industry for the generation of functional ingredients showed that an extract from the wine industry presented beneficial effects on blood pressure in in vitro models as well as in vivo models using rats with hypertension.
Detailed description
The main objective of the study is to evaluate the effect of daily intake of an extract from the wine industry on the change in systolic blood pressure values in individuals with high blood pressure and grade 1 hypertension.
Secondary objectives are to evaluate the effects of an extract from the wine industry on:
- The change in diastolic blood pressure values.
- The change in body weight, body mass index (BMI) and waist circumference.
- The change in the circulating values of total cholesterol, LDL-c, HDL-c, triglycerides and ApoB.
- The change in the atherogenic index of plasma, which combines triglycerides and HDL-c values and which is considered a good indirect indicator of LDL-c particle size and subclinical atherosclerosis.
- Glucose metabolism and insulin resistance.
- The change in the inflammation values analyzed by the marker high sensitivity C-reactive protein.
Study Design: Randomized, crossover, placebo-controlled and double-blind nutritional intervention trial.
The number of subjects in the study will be 40. After the pre-screening visit, the participants will be randomly divided into two groups of 20 participants, according to start the study by taking the extract from the wine industry or placebo for 5 weeks. At the end of the week 5 of the study, when the first treatment is finished, there will be a washing period for 3 weeks and then the treatment will be changed for another 5 weeks: a total of 14 weeks.
The containers of the two treatments, the extract from the wine industry and the placebo, will present the same shape and appearance. The two products will present similar organoleptic characteristics of taste and color.
Each volunteer will make 5 visits, according to the crossover study design:
- a pre-selection visit (to check inclusion / exclusion criteria) (V0; week1) and, in case of meeting the inclusion criteria,
- two study visits during the consumption of the first product (extract from the wine industry or placebo), which will take place on the first day of study (V1; week 2) and after 5 weeks of treatment (V2; week 7).
- two study visits during the consumption of the second product (extract from the wine industry or placebo), which will take place after the three week washout period (V3; week 10) and after 5 weeks of treatment (V4; week 15).
In all visits except the V0 visit, participants must present themselves in fasting conditions of 8 hours to obtain blood. In addition, on V2 visits and V4 the participants will be asked the presence / absence of adverse effects that could be associated with the consumption of the study products.
Main variable: Systolic blood pressure levels.
Secondary variables:
- Diastolic blood pressure levels.
- Body weight.
- Height.
- Body mass index (BMI) (Kg/m2).
- Waist circumference.
- Conicity index.
- Waist circumference/Height ratio.
- Parameters in serum:
- Glucose.
- Insulin.
- Homeostatic Model Assessment for insulin resistance index (HOMA-IR).
- Total cholesterol.
- High density lipoproteins cholesterol (HDL-c).
- Low density lipoproteins cholesterol (LDL-c).
- Triglycerides (TG).
- Atherogenic indices:
- Total cholesterol/HDL-c
- LDL-c/HDL-c
- Plasma atherogenic index, calculated as the logarithm of the TG/HDL-c ratio.
- Apolipoprotein (apo) B.
- C-reactive protein.
- Faecal intestinal microbiota composition.
- Physical activity record.
- Record of potential adverse events.
- Frequency of consumption of supplements to avoid in the study.
- Completion of the intervention.
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 from the wine industry | Experimental | Dietary Supplement: Extract from the wine industryParticipants will consume the extract from the wine industry for 5 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants will consume maltodextrin for 5 weeks. |
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.
- Systolic blood pressure between 130- 159 mm Hg.
- Not under pharmacological treatment or have completed pharmacological treatment at least one month before the start of the study with anti-hypertensive and/or with lipid-lowering drugs. 2. Sign the informed consent.
Key exclusion criteria (12 listed)
- BMI ≥ 35 kg/m^2.
- Have a clinical history of chronic kidney disease, cardiovascular disease and/or cancer.
- Be a smoker or ex-smoker in the last 6 months before inclusion in the study.
- Present diabetes.
- Take supplements with polyphenol components or aimed to lipid or blood pressure control during their participation in the study.
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 |
|---|---|---|
| Extract from the wine industryThe product will be presented in powder format in a single container and with a measuring spoon of the daily dose. | Dietary supplement | Extract from the wine industry |
| PlaceboThe product will be presented in powder format in a single container and with a measuring spoon of the daily dose. | Dietary supplement | Placebo |
Primary outcome
Change in systolic blood pressure
Time frame: Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).
Systolic blood pressure will be measured using an automatic sphygmomanometer.
22 secondary outcomes
Change in diastolic blood pressure
Time frame: Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).
Change in body weight
Time frame: Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).
Height
Time frame: At week 1.
Change in BMI
Time frame: Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).
Changes in waist circumference
Time frame: Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).
Changes in conicity index
Time frame: Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).
Changes in waist circumference to height ratio
Time frame: Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).
Changes in serum glucose levels
Time frame: Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).
Changes in serum insulin levels
Time frame: Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).
Changes in Homeostatic Model Assessment from Insulin Resistance Index (HOMA-IR)
Time frame: Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).
Changes in serum total cholesterol levels.
Time frame: Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).
Changes in serum HDL-c levels.
Time frame: Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).
Changes in serum LDL-c levels.
Time frame: Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).
Changes in serum Triglycerides levels
Time frame: Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).
Changes in total cholesterol to HDL-c ratio
Time frame: Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).
Changes in LDL-c to HDL-c ratio
Time frame: Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).
Changes in Plasma atherogenic index
Time frame: Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).
Changes in serum Apo B levels
Time frame: Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).
Changes in serum C- Reactive protein levels
Time frame: Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).
Changes in intestinal microbiota composition
Time frame: Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).
Change in Physical activity
Time frame: Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).
Adverse events
Time frame: Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC 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 16 Mar 2023.
- Technological Centre of Nutrition and Health. Eurecat\_Reus.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD will be shared with the Universitat Rovira i Virgili for the intestinal microbiota composition analysis
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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.
Josep M Del Bas, PhD principal investigator
UTNS (Eurecat-Reus)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extract from the wine industry in people with Cardiovascular Diseases and Hypertension, run by Fundació Eurecat 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 12 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 16 Mar 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?
Change in systolic blood pressure (time frame: Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC 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 16 Mar 2023.