Arterial StiffnessPhase 2ACENCT05741060
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
A Phase 2 study testing S-equol in people with Arterial Stiffness and White Matter Lesions, run by Akira Sekikawa at 3 sites in United States.
Trial summary
The ACE Trial, funded by the National Institute on Ageing/National Institutes of Health (NIH), is a multicenter clinical trial. The ACE Trial will determine if taking the dietary supplement Equol could slow the progression of stiffening of the arteries, small blood vessel disease in the brain and memory decline. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Arterial Stiffness, White Matter Lesions, Cognitive Decline
- What is being tested?
- S-equol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 369 participants
- Where
- 3 sitesUnited States
- Study dates
- 29 Jun 2023to 31 Jan 2027
- Phase
- Phase 2
- 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 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Men and women age between 65 and 85 at entry of European Americans or African Americans
- Individuals who are able to provide informed consent
- Individuals who are willing to be randomized to the intervention or placebo group
Who cannot join
- Individuals who are regularly taking isoflavone supplements or eat soy product ≥ 2 times a week (by specific questionnaire)
- Individuals who do not agree to maintain isoflavone supplements or soy product intake described above during the study period.
- Individuals who have allergy or intolerance to soy isoflavones.
- Individuals whose score for the Telephone Interview for Cognitive Status is 22 and below.
- Individuals with stroke, neurological disorders, bipolar disease whether or not under medical treatment, cancer treatment in the past 6 months, head trauma or other condition which is not appropriate for the study (e.g., contraindication to magnetic resonance imaging (MRI)).
- Individuals with untreated depression
Show all 45Show fewer
- Individuals with atrial fibrillation
- Individuals with heart failure
- Individuals with heart attack or coronary intervention in the past 6 months
- Individuals with carotid endarterectomy or peripheral artery disease
- Individuals currently undergoing treatment for pulmonary embolism or deep vein thrombosis
- Individuals with aortic (abdominal, thoracic) aneurysm
- Individuals with inflammatory bowel diseases
- Individuals currently undergoing hemodialysis
- Women with a past or family history of breast cancer.*1
- Women on estrogen replacement therapy
- Individuals unable to lay supine for 30-60 minutes
- Individuals with weight ≥300 lbs
- Individuals who are planning to move out of the area in the next 2 years
- Individuals who participated in another clinical trial in the past 3 months
- Individuals with Quick Dementia Rating System (QDRS) score ≥ 6.0
- Individuals who are regularly taking isoflavone supplements or eat soy product ≥ 2 times a week (by specific questionnaire)
- Individuals who do not agree to maintain isoflavone supplements or soy product intake described above during the study period.
- Individuals who have allergy or intolerance to soy isoflavones.
- Blood pressure (BP) - systolic BP ≥ 180 mmHg or diastolic BP ≥ 110 mmHg
- Heart rate ≥110 or ≤40
- Hemoglobin \<10 g/dL
- HbA1c ≥ 7.5%
- Blood creatinine \> 2.0 mg/dL
- Liver function tests \> 2 X upper limit of normal
- Abnormal thyroid function (Thyroid Stimulating Hormone)
- Vitamin B12 levels ≤ 210 pg/mL
- Hematocrit \<30%
- White blood cell count \<3,000 or \>15,000
- Platelet count \<100,000 or \>600,000
- Urinary protein ≥ + by dipstick
- Any condition or therapy which, in the opinion of the investigator, might pose a risk to the participant or make participation in the study not in the participant's best interest
- In addition, individuals with the following condition will be excluded because these conditions do not allow subjects to undergo examinations the investigators proposed in the project:
- Those who are contraindicated for 3 Tesla (3T) structural brain magnetic resonance imaging (MRI) such as pacemakers.
- Atrial fibrillation because pulse wave velocity is not accurately measured.
- Hearing impairment which interferes with cognitive testing
- Vision impairment which interferes with cognitive testing
- Exclusion criteria at structural brain MRI Any other conditions which, in the opinion of the investigator, might pose a risk to the participant or make participation in the study not in the participant's best interest
- 1 Few studies have investigated the association of equol, a metabolite of soy isoflavone daidzein, with breast cancer. These studies reported no significant association of serum or urine equol with the risk of breast cancer. Dietary intake of soy and soy isoflavones is generally considered to have benefits for menopausal symptoms, cardiovascular health, bone health, and cancers of the breast and prostate. Observational studies show that soy consumption is associated with a reduced risk of many cancers including breast cancer. Moreover, a prospective cohort study of 6,000+ North American women with breast cancer showed that dietary intake of soy and isoflavones was associated with reduced all-cause mortality. However, there is little evidence to support that the use of supplements containing soy isoflavones or soy protein powder to reduce cancer risk. A recent large prospective cohort study in France reported that supplementation of soy isoflavones increased the risk of estrogen receptor-negative breast cancer, especially among women who had a history of breast cancer in first-degree relatives.
- The investigators recruit subjects without dementia. Thus, at the initial screening by phone, the investigators exclude individuals whose score for the Telephone Interview for Cognitive Status is 22 and below. Then, at the screening visit, investigators will exclude individuals with a Quick Dementia Rating System score ≥ 6.0.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Emory University
Atlanta, Georgia, 30322
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Arterial Stiffness, Cognition and Equol
The ACE Trial, funded by the National Institute on Ageing/National Institutes of Health (NIH), is a multicenter clinical trial. The ACE Trial will determine if taking the dietary supplement Equol could slow the progression of stiffening of the arteries, small blood vessel disease in the brain and memory decline. Equol is a soy-based supplement that has plant estrogen-like compounds in it.
Equol is a metabolite of soy isoflavone. Our studies in Japan and other studies suggest that Equol may slow mechanisms related to memory decline. No previous studies in the United States have tested the effect of Equol on these mechanisms or memory decline. Supplementation of Equol in the ACE Trial is approved by the Food and Drug Administration (FDA).
Read more
Researchers at the University of Pittsburgh, Pittsburgh, Pennsylvania, Wake Forest University, Winston-Salem, North Carolina, and Emory University, Atlanta, Georgia, are recruiting participants.
The ACE Trial will ask participants to complete 7 clinic visits over a two-year period. The participants are asked to take Equol tablets daily for 24 months. Clinic procedures include Pulse Wave Velocity (to measure arterial stiffness), Magnetic Resonance Imaging (MRI) of the brain and tests of awareness and thinking.
Read the detailed description
The ACE trial is an early-stage multi-center randomized controlled trial (RCT) designed to test the effect of a 24-month intervention of 10 mg/day equol supplementation on arterial stiffness, white matter lesions (WMLs) in the brain and cognitive decline among 400 individuals aged 65 and 85 without dementia. Recent studies in Japan reported that a diet high in soy and soy isoflavones is inversely associated with incident cognitive impairment and dementia. The Women's Isoflavone Soy Health (WISH) in the US, an RCT of soy isoflavones, however, showed no significant effect on cognition. We posit that the discrepant result is due to the difference in equol-producing capability. Equol, a metabolite of soy isoflavone daidzein transformed by the gut microbiome, is the most bioactive among all soy isoflavones and their metabolites. 50-70% of Japanese convert daidzein to equol in contrast to 20-30% of Americans. Arterial stiffness, a significant predictor of cognitive decline, is significantly improved in a short-duration RCT of 10 mg/day equol supplementation in middle-aged subjects. WMLs are a risk factor for age-related cognitive decline and dementia. We reported a longitudinal association of equol-producing status with WML% (WML volume normalized to total brain volume) in cognitively normal elderly in Japan. The subgroup analysis of WISH showed that equol producers had better cognition than the control group, suggesting that equol may slow cognitive decline. No previous study has tested the effect of equol supplementation on arterial stiffness, WMLs or cognitive decline in older adults.
- Conditions
- Arterial Stiffness, White Matter Lesions, Cognitive Decline
- Being tested
- S-equol, Placebo
- Keywords
- s-equol, white matter lesion volume, vascular contributions to cognitive impairment and dementia, arterial stiffness, Alzheimer's disease and related dementias, estrogen receptor-beta agonist
- Medical subject headings
- Cognitive Dysfunction, Dementia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-equolDrug
Also called Equelle
Experimental drug
PlaceboDrug
Placebo - 10 mg per day for 24 months of tablets that will be the same size/shape/color as the s-equol tablets.
| Study group | Role | What they receive |
|---|---|---|
| Equol Arm | Experimental | S-equol - 10 mg per day tablet for 24 months. Receives: Drug: S-equol |
| Placebo Arm | Placebo comparator | 10 mg per day for 24 months of tablets that will be of the same size/shape/color as the experimental tablet. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in arterial stiffness
Arterial stiffness describes the rigidity of the arterial wall and is a significant predictor of cognitive decline. Arterial stiffness will be measured by pulse wave velocity (m/s) with a SphygmoCor device (Sydney, Australia). The range of pulse wave velocity is from 5 to 20 m/s.
Measured: Change from baseline in arterial stiffness at 12 months
Change in arterial stiffness
Arterial stiffness describes the rigidity of the arterial wall and is a significant predictor of cognitive decline. Arterial stiffness will be measured by pulse wave velocity (m/s) with a SphygmoCor device (Sydney, Australia). The range of pulse wave velocity is from 5 to 20 m/s.
Measured: Change from baseline in arterial stiffness at 24 months
Secondary outcomes (3)
Change in white matter lesion (WML) volume percent
WMLs are a significant predictor of cognitive decline. WMLs will be measured using an automated brain magnetic resonance imaging method. WML volume percent will be calculated by dividing WML volume by total brain volume as a percentage. The range of WML volume percent is from 0 to 4.2%.
Measured: Change from baseline in WML volume percent at 24 months
Change in cognitive score measured by the Preclinical Alzheimer's Cognitive Composite-5 (PACC-5) score
The PACC-5 is a composite neuropsychological measure optimized to detect subtle changes over time in cognitively unimpaired older adults. The range of PACC-5 score is from -3 to 3.
Measured: Change from baseline in cognitive score measured by the PACC-5 at 12 months
Change in cognitive score measured by the Preclinical Alzheimer's Cognitive Composite-5 (PACC-5) score.
The PACC-5 is a composite neuropsychological measure optimized to detect subtle changes over time in cognitively unimpaired older adults. The range of PACC-5 score is from -3 to 3 where 3 represents better cognition.
Measured: Change from baseline in cognitive score measured by the PACC-5 at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start29 Jun 2023
- Primary completion29 Oct 2026
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Arterial StiffnessStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The ACE Trial is an early stage multi-center randomized, parallel, double-blind placebo-controlled trial of 10 mg/day of equol for 24 months.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 369 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akira Sekikawa
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor-investigator, Akira Sekikawa, University of Pittsburgh
- Investigators
- Akira Sekikawa, MD, PhD, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05741060
- Sponsor's protocol ID
- STUDY22010165
- Other IDs
- R01AG074971
- Acronym
- ACE
- Status last verified
- Aug 2026
- First submitted
- 13 Feb 2023
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Center for Clinical Trial \& Data Coordination (CCDC), University of Pittsburgh, has rich experience as the Data Core (DC) for other NIH-funded studies, in reporting to and providing final datasets for an NIH Central Data Repository. The final dataset(s) will include demographic and clinical data at baseline, study arm assignment, and all primary and secondary outcomes for the ACE trial. The final dataset(s) will be completely de-identified. These data will be released to an NIH Central Data Repository no later than 1 year after the end of the clinical activity (final patient follow-up, etc.) or immediately after the main paper of the trial has been published, whichever comes first. The files available will include original copies of the case report forms, a detailed codebook of variable names, value labels, formats, missing data reports, and linkage files for samples. The analytic dataset may also include derived variables that were created during the analytic process.
Publications
Sekikawa A, Wharton W, Butts B, Veliky CV, Garfein J, Li J, Goon S, Fort A, Li M, Hughes TM. Potential Protective Mechanisms of S-equol, a Metabolite of Soy Isoflavone by the Gut Microbiome, on Cognitive Decline and Dementia. Int J Mol Sci. 2022 Oct 7;23(19):11921. doi: 10.3390/ijms231911921.
PubMed 36233223Sekikawa A, Wharton W, Murray-Krezan C, Wu M, Chang Y, Snitz BE, Coccari M, Yang S, Love ML, Cusick D, Wang R, Li M, Park C, Li J, DeConne TM, Smith C, Verble DD, Lancet MQ, Foroud T, Kim T, Nadkarni NK, Mettenburg JM, Zamora E, Lopez OL, Hughes TM. ACE trial design: Equol targeting estrogen receptor-beta in vascular and cognitive aging. Alzheimers Dement (N Y). 2025 Aug 18;11(3):e70144. doi: 10.1002/trc2.70144. eCollection 2025 Jul-Sep.
PubMed 40838083
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arterial Stiffness, Cognition and Equol
- ClinicalTrials.gov ID
- NCT05741060
- Acronym / sponsor ID
- ACE / STUDY22010165
- Conditions
- Arterial Stiffness, White Matter Lesions, Cognitive Decline
- Keywords
- s-equol, white matter lesion volume, vascular contributions to cognitive impairment and dementia, arterial stiffness, Alzheimer's disease and related dementias, estrogen receptor-beta agonist
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 369 participants (actual)
- Lead sponsor
- Akira SekikawaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 29 Jun 2023 (actual)
- Primary completion
- 29 Oct 2026 (actual)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 23 Feb 2023 (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 ACE Trial, funded by the National Institute on Ageing/National Institutes of Health (NIH), is a multicenter clinical trial. The ACE Trial will determine if taking the dietary supplement Equol could slow the progression of stiffening of the arteries, small blood vessel disease in the brain and memory decline. Equol is a soy-based supplement that has plant estrogen-like compounds in it.
Equol is a metabolite of soy isoflavone. Our studies in Japan and other studies suggest that Equol may slow mechanisms related to memory decline. No previous studies in the United States have tested the effect of Equol on these mechanisms or memory decline. Supplementation of Equol in the ACE Trial is approved by the Food and Drug Administration (FDA).
Researchers at the University of Pittsburgh, Pittsburgh, Pennsylvania, Wake Forest University, Winston-Salem, North Carolina, and Emory University, Atlanta, Georgia, are recruiting participants.
The ACE Trial will ask participants to complete 7 clinic visits over a two-year period. The participants are asked to take Equol tablets daily for 24 months. Clinic procedures include Pulse Wave Velocity (to measure arterial stiffness), Magnetic Resonance Imaging (MRI) of the brain and tests of awareness and thinking.
Detailed description
The ACE trial is an early-stage multi-center randomized controlled trial (RCT) designed to test the effect of a 24-month intervention of 10 mg/day equol supplementation on arterial stiffness, white matter lesions (WMLs) in the brain and cognitive decline among 400 individuals aged 65 and 85 without dementia. Recent studies in Japan reported that a diet high in soy and soy isoflavones is inversely associated with incident cognitive impairment and dementia. The Women's Isoflavone Soy Health (WISH) in the US, an RCT of soy isoflavones, however, showed no significant effect on cognition. We posit that the discrepant result is due to the difference in equol-producing capability. Equol, a metabolite of soy isoflavone daidzein transformed by the gut microbiome, is the most bioactive among all soy isoflavones and their metabolites. 50-70% of Japanese convert daidzein to equol in contrast to 20-30% of Americans. Arterial stiffness, a significant predictor of cognitive decline, is significantly improved in a short-duration RCT of 10 mg/day equol supplementation in middle-aged subjects. WMLs are a risk factor for age-related cognitive decline and dementia. We reported a longitudinal association of equol-producing status with WML% (WML volume normalized to total brain volume) in cognitively normal elderly in Japan. The subgroup analysis of WISH showed that equol producers had better cognition than the control group, suggesting that equol may slow cognitive decline. No previous study has tested the effect of equol supplementation on arterial stiffness, WMLs or cognitive decline in older adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The ACE Trial is an early stage multi-center randomized, parallel, double-blind placebo-controlled trial of 10 mg/day of equol for 24 months.
| Arm | Type | Receives |
|---|---|---|
| Equol Arm | Experimental | Drug: S-equolS-equol - 10 mg per day tablet for 24 months. |
| Placebo Arm | Placebo comparator | Drug: Placebo10 mg per day for 24 months of tablets that will be of the same size/shape/color as the experimental tablet. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Men and women age between 65 and 85 at entry of European Americans or African Americans
- Individuals who are able to provide informed consent
- Individuals who are willing to be randomized to the intervention or placebo group
Key exclusion criteria (45 listed)
- Individuals who are regularly taking isoflavone supplements or eat soy product ≥ 2 times a week (by specific questionnaire)
- Individuals who do not agree to maintain isoflavone supplements or soy product intake described above during the study period.
- Individuals who have allergy or intolerance to soy isoflavones.
- Individuals whose score for the Telephone Interview for Cognitive Status is 22 and below.
- Individuals with stroke, neurological disorders, bipolar disease whether or not under medical treatment, cancer treatment in the past 6 months, head trauma or other condition which is not appropriate for the study (e.g., contraindication to magnetic resonance imaging (MRI)).
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 |
|---|---|---|
| S-equolAlso: EquelleExperimental drug | Drug | Equol Arm |
| PlaceboPlacebo - 10 mg per day for 24 months of tablets that will be the same size/shape/color as the s-equol tablets. | Drug | Placebo Arm |
Primary outcome
Change in arterial stiffness
Time frame: Change from baseline in arterial stiffness at 12 months
Arterial stiffness describes the rigidity of the arterial wall and is a significant predictor of cognitive decline. Arterial stiffness will be measured by pulse wave velocity (m/s) with a SphygmoCor device (Sydney, Australia). The range of pulse wave velocity is from 5 to 20 m/s.
Change in arterial stiffness
Time frame: Change from baseline in arterial stiffness at 24 months
Arterial stiffness describes the rigidity of the arterial wall and is a significant predictor of cognitive decline. Arterial stiffness will be measured by pulse wave velocity (m/s) with a SphygmoCor device (Sydney, Australia). The range of pulse wave velocity is from 5 to 20 m/s.
3 secondary outcomes
Change in white matter lesion (WML) volume percent
Time frame: Change from baseline in WML volume percent at 24 months
Change in cognitive score measured by the Preclinical Alzheimer's Cognitive Composite-5 (PACC-5) score
Time frame: Change from baseline in cognitive score measured by the PACC-5 at 12 months
Change in cognitive score measured by the Preclinical Alzheimer's Cognitive Composite-5 (PACC-5) score.
Time frame: Change from baseline in cognitive score measured by the PACC-5 at 24 months
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 5 Nov 2026.
- Background: PubMed 36233223Sekikawa A, Wharton W, Butts B, Veliky CV, Garfein J, Li J, Goon S, Fort A, Li M, Hughes TM. Potential Protective Mechanisms of S-equol, a Metabolite of Soy Isoflavone by the Gut Microbiome, on Cognitive Decline and Dementia. Int J Mol Sci. 2022 Oct 7;23(19):11921. doi: 10.3390/ijms231911921.
- Results publication: PubMed 40838083Sekikawa A, Wharton W, Murray-Krezan C, Wu M, Chang Y, Snitz BE, Coccari M, Yang S, Love ML, Cusick D, Wang R, Li M, Park C, Li J, DeConne TM, Smith C, Verble DD, Lancet MQ, Foroud T, Kim T, Nadkarni NK, Mettenburg JM, Zamora E, Lopez OL, Hughes TM. ACE trial design: Equol targeting estrogen receptor-beta in vascular and cognitive aging. Alzheimers Dement (N Y). 2025 Aug 18;11(3):e70144. doi: 10.1002/trc2.70144. eCollection 2025 Jul-Sep.
- Individual participant dataSharing planned: Yes. The Center for Clinical Trial \& Data Coordination (CCDC), University of Pittsburgh, has rich experience as the Data Core (DC) for other NIH-funded studies, in reporting to and providing final datasets for an NIH Central Data Repository. The final dataset(s) will include demographic and clinical data at baseline, study arm assignment, and all primary and secondary outcomes for the ACE trial. The final dataset(s) will be completely de-identified. These data will be released to an NIH Central Data Repository no later than 1 year after the end of the clinical activity (final patient follow-up, etc.) or immediately after the main paper of the trial has been published, whichever comes first. The files available will include original copies of the case report forms, a detailed codebook of variable names, value labels, formats, missing data reports, and linkage files for samples. The analytic dataset may also include derived variables that were created during the analytic process.
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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.
Akira Sekikawa, MD, PhD, PhD principal investigator
University of Pittsburgh
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing S-equol in people with Arterial Stiffness and White Matter Lesions, run by Akira Sekikawa at 3 sites in United States.
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 45 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: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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 arterial stiffness (time frame: Change from baseline in arterial stiffness at 12 months). The study lists 2 primary outcomes in all. 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 NCT05741060, which also lists 2 linked publications.
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 5 Nov 2026.