Cardiovascular HealthBERSNCT07666685
Beetroot Extract and Quality of Life in Adults Aged 75 and Over
A study testing Beetroot Extract Supplementation in people with Cardiovascular Health and Functional Health, run by Fundacion Miguel Servet at 1 site in Spain.
Trial summary
The increasing number of adults aged 75 years and older highlights the need for effective, low-cost interventions to preserve cardiovascular health, functional independence, and cognitive performance and to support healthy aging. Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Health, Functional Health, Cognitive Function Decline
- What is being tested?
- Beetroot Extract Supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 24 Mar 2026to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Adults aged 75 years and older recruited from the Geriatrics Service of the Hospital Universitario de Navarra (HUN) or primary care settings.
- Ability to ambulate independently.
- Ability to communicate effectively.
- Ability to tolerate physical exercise.
- Barthel Index score greater than 60 points.
Who cannot join
- Refusal or inability of the participant, caregiver, or legal guardian to provide written informed consent.
- Advanced or severe dementia (Global Deterioration Scale [GDS] stages 6-7).
- Unstable medical condition or terminal illness with a life expectancy of less than 6 months.
- Ischemic heart disease or congestive heart failure.
- Severe renal insufficiency.
- Hypotension.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario de Navarra
Pamplona, Navarre, 31008
About this study
Official title: Assessment of the Benefits of Beetroot Extract for Improving the Quality of Life of Older People: a Randomised Clinical Trial.
The increasing number of adults aged 75 years and older highlights the need for effective, low-cost interventions to preserve cardiovascular health, functional independence, and cognitive performance and to support healthy aging. Beetroot extract (BE), derived from "Beta vulgaris", contains high levels of inorganic nitrate and other bioactive compounds that may positively influence vascular and neuromuscular function. In parallel, multicomponent physical exercise is recognized as an effective strategy to improve physical and cognitive outcomes in older adults. However, evidence on the independent and combined effects of BE supplementation and structured exercise in very old adults remains limited.
This randomized controlled trial is designed to evaluate the effects of BE supplementation, alone and in combination with a multicomponent physical exercise program, on blood pressure, functional performance, and cognitive function in adults aged 75 years and older. Participants will be randomly assigned to one of four groups: BE supplementation, multicomponent exercise, combined BE supplementation and exercise, or a control condition, over a predefined intervention period. The exercise program will include strength, balance, mobility, and aerobic components specifically adapted to the abilities and safety requirements of old adults.
The primary outcomes of the study will assess changes in cardiovascular health, physical and functional performance, and cognitive function using standardized and validated assessment tools. Secondary outcomes will include additional indicators of physical capacity and health-related quality of life. This trial aims to provide clinically relevant evidence on whether BE supplementation, alone or in combination with multicomponent exercise, represents a practical and scalable intervention to improve cardiovascular, functional, and cognitive health in adults aged 75 years and older.
- Conditions
- Cardiovascular Health, Functional Health, Cognitive Function Decline, Physical Performance Decline in Older Adults
- Being tested
- Beetroot Extract Supplementation, Placebo group: nitrate-depleted beetroot juice
- Keywords
- beetroot extract, dietary nitrate, cardiovascular health, functional health, quality of life, cognitive function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beetroot Extract SupplementationDietary supplement
Participants receive daily supplementation with beetroot extract juice, with or without participation in a multicomponent physical exercise program, depending on group allocation. When applicable, the exercise program targets strength, balance, mobility, and aerobic capacity, and is supervised by trained professionals during the first 6 weeks and subsequently prescribed but not supervised for the following 6 weeks. This intervention aims to evaluate the independent and combined effects of beetroot extract supplementation and physical exercise on cardiovascular, functional, and cognitive outcomes in adults aged 75 years and older.
Placebo group: nitrate-depleted beetroot juiceDietary supplement
Participants receive daily supplementation with nitrate-depleted beetroot juice, with or without participation in a multicomponent physical exercise program, according to group allocation. The placebo juice is derived from beetroot but has had its nitrate content removed, maintaining similar appearance, taste, and texture to the active supplement. When applicable, the exercise program targets strength, balance, mobility, and aerobic capacity and is supervised by trained professionals during the first 6 weeks, followed by a prescribed but unsupervised phase for the subsequent 6 weeks. This placebo-controlled intervention is designed to isolate the effects of dietary nitrate from beetroot extract and to evaluate the independent and combined effects of physical exercise on cardiovascular, functional, and cognitive outcomes in adults aged 75 years and older.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Control Group | Placebo comparator | Participants receive a placebo (nitrate-depleted beetroot juice) and continue with their usual daily activities without any additional intervention. Receives: Dietary Supplement: Placebo group: nitrate-depleted beetroot juice |
| Beetroot Extract Supplementation | Experimental | Participants receive daily supplementation with beetroot extract juice and continue with their usual daily activities. Receives: Dietary Supplement: Beetroot Extract Supplementation |
| Beetroot Extract Plus Multicomponent Exercise | Experimental | Participants engage in a multicomponent physical exercise program, supervised during the first 6 weeks and then prescribed but not supervised for the following 6 weeks, combined with daily supplementation of beetroot extract juice. Receives: Dietary Supplement: Beetroot Extract Supplementation |
| Placebo Plus Multicomponent Exercise | Active comparator | Participants engage in a multicomponent physical exercise program, supervised during the first 6 weeks and then prescribed but not supervised for the following 6 weeks, combined with placebo supplementation (nitrate-depleted beetroot juice). Receives: Dietary Supplement: Placebo group: nitrate-depleted beetroot juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
Blood pressure (systolic and diastolic) will be measured three times in a row, and the average of the three readings will be calculated.
Measured: At baseline - 6 weeks - 12 weeks
Heart rate
Heart rate will be measured at rest, after the 6-minute walk test, and then 3 minutes after the test has finished.
Measured: [Time Frame: Baseline - 6 weeks and 12 weeks]
Stroop Test
This test measures cognitive control and attention by asking individuals to name the color of a word rather than the word itself. It evaluates the ability to manage interference between conflicting information.
Measured: At baseline - 6 weeks - 12 weeks
Symbol Digit Modalities Test (SDMT)
This test assesses processing speed, attention, and working memory by requiring individuals to match symbols with corresponding numbers under time pressure. Faster and more accurate performance indicates better cognitive functioning.
Measured: At Baseline - 6 weeks - 12 weeks
Trail Making Test - A (TMT-A)
This test evaluates visual attention and task switching by asking individuals to connect a sequence of numbers (Part A). It measures cognitive flexibility, speed, and executive function.
Measured: At baseline - 6 weeks - 12 weeks
6 minute walk test (6MWT)
This test measures functional exercise capacity by assessing how far a person can walk in six minutes on a flat surface. It reflects endurance and helps evaluate cardiovascular, respiratory, and musculoskeletal function.
Measured: At baseline - 6 weeks - 12 weeks
Short Physical Performance Battery (SPPB)
Physical Function: Assessed using the Short Physical Performance Battery (SPPB), which combines balance, gait velocity, and leg strength as a single score on a 0 (worst) to 12 (best scale)
Measured: At baseline - 6 weeks - 12 weeks
Strength
Handgrip strength and maximal concentric strength (leg press, chest press, knee extension, seated row machine). Changes in "1RM", defined as the maximum resistance/load a person can move in one repetition of an exercise will be assessed. These values are mesured in Kilograms and results are individualized.
Measured: At baseline - 6 weeks - 12 weeks
Quality of life (QoL)
Measurment of quality of life using EQ5D-3L, the patients indicate their health state by choosing one level for each of the five dimensions, creating a 5-digit code representing 243 possible health states. EQ VAS, includes a vertical Visual Analogue Scale (0-100) where patients rate their self-rated health, with 100 being the "best imaginable health state". Utility. The responses can be converted into a single index value (utility score) using country-specific valuation sets, where 1 represents full health and 0 represents death.
Measured: At baseline - 12 weeks
Medication Use (Polypharmacy and Psychotropic Drugs)
Number and type of medications will be recorded. Polypharmacy will be defined as the use of ≥5 medications. Psychotropic drug use and medications related to comorbid or intercurrent conditions (e.g., antibiotics) will also be documented
Measured: At baseline - 12 weeks
Sleep Health Index (SATED)
SATED : This questionnaire assesses sleep health across five dimensions: Satisfaction, Alertness, Timing, Efficiency, and Duration. It provides a brief evaluation of overall sleep quality and habits.
Measured: At baseline - 12 weeks
Nutritional Status
Mini Nutritional Assessment (MNA) ranges from normal nutritional status (24-30points), risk of malnutrition (17-23.5points), or malnourished(<17points).
Measured: At baseline
Barthel Index
Barthel Index of independence during activities of dailyliving (ADLs) ranges from 0 (severe functional dependence) to 100 (functional independence).
Measured: At baseline
International Physical Activity Questionnaire (IPAQ)
This questionnaire measures physical activity levels by asking about the frequency and duration of different intensities of activity. It is used to estimate total physical activity and categorize individuals into activity levels.
Measured: At baseline
Mini-Mental State Examination (MMSE)
This test is a brief screening tool used to assess cognitive function, including orientation, memory, attention, language, and visuospatial skills. It helps identify cognitive impairment and monitor changes over time.
Measured: At baseline
Secondary outcomes (3)
Continuous Glucose Monitoring
Continuous Glucose Monitoring (FreeStyle Libre 2): This system measures glucose levels continuously through a small sensor placed on the skin, providing real-time data without frequent finger pricks. It helps track glucose trends and fluctuations, supporting better diabetes management and treatment decisions.
Measured: During the first 15 days
Laboratory Parameters: Blood Nitrate and Nitric Oxide Assessment
Blood Nitrate and Nitric Oxide Assessment: This measurement evaluates nitric oxide (NO) bioavailability by analyzing changes in blood nitrate levels, a stable indirect marker of NO production, typically expressed in µmol/L. . Blood samples (10-20 mL) will be collected alongside routine clinical testing using Vacutainer tubes (EDTA, citrate, or serum tubes as appropriate). Samples will be left upright for 10 minutes and centrifuged at 3000 rpm for 15 minutes to obtain serum and plasma for analysis. Aliquots will be stored at -80°C for future specialised analyses, including flow cytometry.
Measured: At baseline - 6 weeks - 12 weeks
Body Composition by Bioimpedance
Body Composition by Bioimpedance (BIA 101 BIVA® PRO): This method assesses body composition by measuring electrical impedance through a two-electrode system, providing estimates of body water, fat mass, and fat-free mass. It also uses bioelectrical impedance vector analysis (BIVA) to evaluate hydration status and cellular health, offering insights into nutritional and physiological condition.
Measured: At baseline - 6 weeks - 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start24 Mar 2026
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Miguel Servet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas Martinez-Velilla, MD-PhD, Principal investigator, Navarrabiomed-Fundación Miguel Servet-Hospital Universitario de Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07666685
- Sponsor's protocol ID
- BERS
- Acronym
- BERS
- Status last verified
- Jun 2026
- First submitted
- 26 May 2026
- Last updated
- 30 Jun 2026
- 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 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Benefits of Beetroot Extract for Improving the Quality of Life of Older People: a Randomised Clinical Trial.
- ClinicalTrials.gov ID
- NCT07666685
- Acronym / sponsor ID
- BERS / BERS
- Conditions
- Cardiovascular Health, Functional Health, Cognitive Function Decline, Physical Performance Decline in Older Adults
- Keywords
- beetroot extract, dietary nitrate, cardiovascular health, functional health, quality of life, cognitive function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fundacion Miguel ServetUniversity, hospital or other
- Study start
- 24 Mar 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 24 Jun 2026 (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 increasing number of adults aged 75 years and older highlights the need for effective, low-cost interventions to preserve cardiovascular health, functional independence, and cognitive performance and to support healthy aging. Beetroot extract (BE), derived from "Beta vulgaris", contains high levels of inorganic nitrate and other bioactive compounds that may positively influence vascular and neuromuscular function. In parallel, multicomponent physical exercise is recognized as an effective strategy to improve physical and cognitive outcomes in older adults. However, evidence on the independent and combined effects of BE supplementation and structured exercise in very old adults remains limited.
This randomized controlled trial is designed to evaluate the effects of BE supplementation, alone and in combination with a multicomponent physical exercise program, on blood pressure, functional performance, and cognitive function in adults aged 75 years and older. Participants will be randomly assigned to one of four groups: BE supplementation, multicomponent exercise, combined BE supplementation and exercise, or a control condition, over a predefined intervention period. The exercise program will include strength, balance, mobility, and aerobic components specifically adapted to the abilities and safety requirements of old adults.
The primary outcomes of the study will assess changes in cardiovascular health, physical and functional performance, and cognitive function using standardized and validated assessment tools. Secondary outcomes will include additional indicators of physical capacity and health-related quality of life. This trial aims to provide clinically relevant evidence on whether BE supplementation, alone or in combination with multicomponent exercise, represents a practical and scalable intervention to improve cardiovascular, functional, and cognitive health in adults aged 75 years and older.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo Control Group | Placebo comparator | Dietary Supplement: Placebo group: nitrate-depleted beetroot juiceParticipants receive a placebo (nitrate-depleted beetroot juice) and continue with their usual daily activities without any additional intervention. |
| Beetroot Extract Supplementation | Experimental | Dietary Supplement: Beetroot Extract SupplementationParticipants receive daily supplementation with beetroot extract juice and continue with their usual daily activities. |
| Beetroot Extract Plus Multicomponent Exercise | Experimental | Dietary Supplement: Beetroot Extract SupplementationParticipants engage in a multicomponent physical exercise program, supervised during the first 6 weeks and then prescribed but not supervised for the following 6 weeks, combined with daily supplementation of beetroot extract juice. |
| Placebo Plus Multicomponent Exercise | Active comparator | Dietary Supplement: Placebo group: nitrate-depleted beetroot juiceParticipants engage in a multicomponent physical exercise program, supervised during the first 6 weeks and then prescribed but not supervised for the following 6 weeks, combined with placebo supplementation (nitrate-depleted beetroot juice). |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Adults aged 75 years and older recruited from the Geriatrics Service of the Hospital Universitario de Navarra (HUN) or primary care settings.
- Ability to ambulate independently.
- Ability to communicate effectively.
- Ability to tolerate physical exercise.
- Barthel Index score greater than 60 points.
Key exclusion criteria (6 listed)
- Refusal or inability of the participant, caregiver, or legal guardian to provide written informed consent.
- Advanced or severe dementia (Global Deterioration Scale [GDS] stages 6-7).
- Unstable medical condition or terminal illness with a life expectancy of less than 6 months.
- Ischemic heart disease or congestive heart failure.
- Severe renal insufficiency.
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 |
|---|---|---|
| Beetroot Extract SupplementationParticipants receive daily supplementation with beetroot extract juice, with or without participation in a multicomponent physical exercise program, depending on group allocation. When applicable, the exercise program targets strength, balance, mobility, and aerobic capacity, and is supervised by trained professionals during the first 6 weeks and subsequently prescribed but not supervised for the following 6 weeks. This intervention aims to evaluate the independent and combined effects of beetroot extract supplementation and physical exercise on cardiovascular, functional, and cognitive outcomes in adults aged 75 years and older. | Dietary supplement | Beetroot Extract Plus Multicomponent Exercise, Beetroot Extract Supplementation |
| Placebo group: nitrate-depleted beetroot juiceParticipants receive daily supplementation with nitrate-depleted beetroot juice, with or without participation in a multicomponent physical exercise program, according to group allocation. The placebo juice is derived from beetroot but has had its nitrate content removed, maintaining similar appearance, taste, and texture to the active supplement. When applicable, the exercise program targets strength, balance, mobility, and aerobic capacity and is supervised by trained professionals during the first 6 weeks, followed by a prescribed but unsupervised phase for the subsequent 6 weeks. This placebo-controlled intervention is designed to isolate the effects of dietary nitrate from beetroot extract and to evaluate the independent and combined effects of physical exercise on cardiovascular, functional, and cognitive outcomes in adults aged 75 years and older. | Dietary supplement | Placebo Control Group, Placebo Plus Multicomponent Exercise |
Primary outcome
Blood Pressure
Time frame: At baseline - 6 weeks - 12 weeks
Blood pressure (systolic and diastolic) will be measured three times in a row, and the average of the three readings will be calculated.
Heart rate
Time frame: [Time Frame: Baseline - 6 weeks and 12 weeks]
Heart rate will be measured at rest, after the 6-minute walk test, and then 3 minutes after the test has finished.
Stroop Test
Time frame: At baseline - 6 weeks - 12 weeks
This test measures cognitive control and attention by asking individuals to name the color of a word rather than the word itself. It evaluates the ability to manage interference between conflicting information.
Symbol Digit Modalities Test (SDMT)
Time frame: At Baseline - 6 weeks - 12 weeks
This test assesses processing speed, attention, and working memory by requiring individuals to match symbols with corresponding numbers under time pressure. Faster and more accurate performance indicates better cognitive functioning.
Trail Making Test - A (TMT-A)
Time frame: At baseline - 6 weeks - 12 weeks
This test evaluates visual attention and task switching by asking individuals to connect a sequence of numbers (Part A). It measures cognitive flexibility, speed, and executive function.
6 minute walk test (6MWT)
Time frame: At baseline - 6 weeks - 12 weeks
This test measures functional exercise capacity by assessing how far a person can walk in six minutes on a flat surface. It reflects endurance and helps evaluate cardiovascular, respiratory, and musculoskeletal function.
Short Physical Performance Battery (SPPB)
Time frame: At baseline - 6 weeks - 12 weeks
Physical Function: Assessed using the Short Physical Performance Battery (SPPB), which combines balance, gait velocity, and leg strength as a single score on a 0 (worst) to 12 (best scale)
Strength
Time frame: At baseline - 6 weeks - 12 weeks
Handgrip strength and maximal concentric strength (leg press, chest press, knee extension, seated row machine). Changes in "1RM", defined as the maximum resistance/load a person can move in one repetition of an exercise will be assessed. These values are mesured in Kilograms and results are individualized.
Quality of life (QoL)
Time frame: At baseline - 12 weeks
Measurment of quality of life using EQ5D-3L, the patients indicate their health state by choosing one level for each of the five dimensions, creating a 5-digit code representing 243 possible health states. EQ VAS, includes a vertical Visual Analogue Scale (0-100) where patients rate their self-rated health, with 100 being the "best imaginable health state". Utility. The responses can be converted into a single index value (utility score) using country-specific valuation sets, where 1 represents full health and 0 represents death.
Medication Use (Polypharmacy and Psychotropic Drugs)
Time frame: At baseline - 12 weeks
Number and type of medications will be recorded. Polypharmacy will be defined as the use of ≥5 medications. Psychotropic drug use and medications related to comorbid or intercurrent conditions (e.g., antibiotics) will also be documented
Sleep Health Index (SATED)
Time frame: At baseline - 12 weeks
SATED : This questionnaire assesses sleep health across five dimensions: Satisfaction, Alertness, Timing, Efficiency, and Duration. It provides a brief evaluation of overall sleep quality and habits.
Nutritional Status
Time frame: At baseline
Mini Nutritional Assessment (MNA) ranges from normal nutritional status (24-30points), risk of malnutrition (17-23.5points), or malnourished(<17points).
Barthel Index
Time frame: At baseline
Barthel Index of independence during activities of dailyliving (ADLs) ranges from 0 (severe functional dependence) to 100 (functional independence).
International Physical Activity Questionnaire (IPAQ)
Time frame: At baseline
This questionnaire measures physical activity levels by asking about the frequency and duration of different intensities of activity. It is used to estimate total physical activity and categorize individuals into activity levels.
Mini-Mental State Examination (MMSE)
Time frame: At baseline
This test is a brief screening tool used to assess cognitive function, including orientation, memory, attention, language, and visuospatial skills. It helps identify cognitive impairment and monitor changes over time.
3 secondary outcomes
Continuous Glucose Monitoring
Time frame: During the first 15 days
Laboratory Parameters: Blood Nitrate and Nitric Oxide Assessment
Time frame: At baseline - 6 weeks - 12 weeks
Body Composition by Bioimpedance
Time frame: At baseline - 6 weeks - 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
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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.
Nicolas Martinez-Velilla, MD-PhD principal investigator
Navarrabiomed-Fundación Miguel Servet-Hospital Universitario de Navarra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beetroot Extract Supplementation in people with Cardiovascular Health and Functional Health, run by Fundacion Miguel Servet 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 5 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: looking for participants now, as of the sponsor's last update on 30 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas Martinez-Velilla, Md-PhD (00 34 848422222, nicolas.martinez.velilla@navarrra.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure (time frame: At baseline - 6 weeks - 12 weeks). The study lists 15 primary outcomes in all. 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 30 Jun 2026.