Metabolic SyndromeNCT02561663
NWT03 and Arterial Stiffness
A study testing NWT-03, an egg-white protein hydrolysate in people with Metabolic Syndrome, run by Newtricious R&D BV at 1 site in Netherlands.
Trial summary
Rationale: Subjects with the metabolic syndrome have an increased risk of developing cardiovascular disease and a twofold risk of developing hypertension. A functional food ingredient with the ability to improve arterial stiffness, microcirculation and/or the ability to reduce blood pressure could potentially… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- NWT-03, an egg-white protein hydrolysate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2015to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To be considered eligible for enrolment into the study, subjects must;
- Be able to give written informed consent,
- Be between 18 and 75 years of age,
- Be in generally good health as determined by the investigator,
- Be non-smokers
- Have a stable body weight (< 5% change) in the 3 months prior to study entry,
Show all 12Show fewer
- Meet the harmonized criteria for the presence of Metabolic Syndrome as agreed by the International Diabetes Federation (IDF), National Heart Lung and Blood Institute, American Heart Association, World Heart Federation, International Atherosclerosis Society and International Association for the Study of Obesity [2], and defined as having at least three of the five following risk factors:
- Central obesity (waist circumference >94cms in males or > 80cms in females) or having a BMI > 30 kg/m2
- Raised triglycerides (>1.7 mmol/L (150mg/dL)
- Reduced HDL cholesterol [<1.03mmol/L (40mg/dL) in males, <1.29mmol/L (50mg/dL) in females]
- Raised fasting plasma glucose > 5.6mmol/L (100mg/dL)
- Raised blood pressure (systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmHg)
Who cannot join
- Subjects will be excluded from the study if they meet any of the below criteria;
- Are less than 18 years of age or over 75 years of age,
- Females who are pregnant, breast feeding or who may wish to become pregnant during the study,
- Are hypersensitive to any of the components of the test product (i.e. egg protein),
- Have a significant acute or chronic coexisting illness such as cardiovascular disease, chronic kidney disease (CKD), gastrointestinal disorder, endocrinological disorder, immunological disorder, metabolic disease or any condition which contraindicates, in the investigators judgement, entry to the study,
- Having a condition or have taken a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results; to include diuretics, blood pressure lowering medication and medication otherwise interfering with renin-angiotensin-aldosterone system (RAAS), such as ACE-inhibitors, angiotensin receptor blockers, direct renin inhibitors or aldosterone receptor inhibitor and cholesterol lowering agents such as statins.
Show all 14Show fewer
- Are taking non-steroidal anti-inflammatory drugs (NSAIDs) within 2 weeks of baseline visit or for the duration of the trial,
- Suffer from diabetes mellitus, either type I and type II,
- Consume more than the recommended alcohol guidelines i.e. >21 alcohol units/week for males and >14 units/week for females,
- History of illicit drug use,
- Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial,
- Subjects may not be receiving treatment involving experimental drugs,
- If the subject has been in a recent experimental trial, these must have been completed not less than 60 days prior to this study or if the subject has donated blood, at a blood bank, within a period of 8 weeks prior to the start of the study.
- Have a malignant disease or any concomitant end-stage organ disease
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Centre+
Maastricht, Limburg, 6229ER
About this study
Official title: A Randomized, Double-blind, Placebo Controlled, Crossover Study to Determine the Effect of 5g Egg Protein Hydrolysate (NWT-03) on Arterial Stiffness, Microcirculation and Blood Pressure in Otherwise Healthy Subjects With Metabolic Syndrome
Rationale: Subjects with the metabolic syndrome have an increased risk of developing cardiovascular disease and a twofold risk of developing hypertension. A functional food ingredient with the ability to improve arterial stiffness, microcirculation and/or the ability to reduce blood pressure could potentially contribute to the delay or prevention of a range of cardiovascular diseases and could provide additional complimentary alternatives to pharmacological and lifestyle based interventions in the maintenance of cardiovascular health.
Objective: To assess the acute (2h) and short term (2 days and 4 week) effects of daily administration of 5g of NWT03 (an egg-protein hydrolysate) on carotid-radial Pulse Wave Velocity (cr-PWV). Secondary objectives are to assess its effects on carotid-femoral PWV, characteristics of microcirculation, systolic and diastolic blood pressure, lipid and lipoprotein metabolism, glucose metabolism and incretins.
Read more
Study design: Investigators propose to carry out a randomized, double-blind, placebo controlled crossover study.
Study population: Eligible subjects will be male or female, non-smokers between 18-75 years of age and will be otherwise healthy, but meeting at least three criteria of the Metabolic Syndrome (MetS). It is estimated that 80 otherwise healthy subjects with MetS will be randomised, to result in a minimum of 72 evaluable subjects (drop out maximal 10%) at the end of the study.
Intervention: Subjects will be randomly allocated to receive 5g of NWT-03 and placebo, once daily, on separate occasions, for a period of 4 weeks and with a washout period between the two interventions of typically 4 weeks. However, this period may be shortened by 2 weeks or extended by 8 weeks, depending on the availability of the subject. Total study duration will be 10 - 16 weeks, depending on the duration of the washout period.
Main study parameters/endpoints: Measurements will be performed at the start and end of each 4-week intervention period. Effects of NWT-03 supplementation will be calculated as the absolute differences between values obtained at each period. The main study endpoint is the change in cr-PWV.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Before the study starts, subjects will be screened to determine eligibility during a screening visit. During this visit, body weight, height, waist circumference and blood pressure will be measured and a venous blood sample (10 mL) will be collected. During the study, subjects will receive NWT-03 and placebo powders in random order and are asked to consume it on a daily basis. At visits 2, 3, 4, 5, 6 and 7 (days 0, 2, 27, 56, 58 and 83 of the study), cr-PWV, cf-PWV and office blood pressure will be recorded. A fundus photograph and a blood sample (20mL) will be taken in fasting condition. 2 hours after intake of the designated study product cr-PWV, cf-PWV and office blood pressure will again be measured and another fundus photograph will be taken. Additionally, a blood sample (20 mL) will be collected. Thus, in total 270 mL blood will be drawn. A pregnancy test will be taken in females of childbearing potential at visits 2 and 5. Subjects will be asked to fill out a food frequency questionnaire and to provide a spot urine sample at visits 4 and 7. Furthermore, subjects will be asked to keep a study diary throughout the duration of the study. Total time investment for the subjects will be approximately 19 hours. Apart from bruises or hematoma, rarely induced by blood sampling, no risks are associated with participation in this study.
- Conditions
- Metabolic Syndrome
- Being tested
- NWT-03, an egg-white protein hydrolysate, Placebo
- Keywords
- microcirculation, blood pressure, pulse wave analysis, pulse wave velocity
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NWT-03, an egg-white protein hydrolysateDietary supplement
egg-white protein hydrolysate
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| NWT-03, followed by placebo | Experimental | Dietary Supplement: NWT-03, an egg-white protein hydrolysate For placebo comparator, a combination of sweetener + aroma, which was equal to the combination used in the intervention period, was given Dietary Supplement: Placebo A combination of sweetener + aroma , which was equal to the combination used in the intervention period, was given. Receives: Dietary Supplement: NWT-03, an egg-white protein hydrolysate; Other: Placebo |
| Placebo, followed by NWT-03 | Experimental | Dietary Supplement: NWT-03, an egg-white protein hydrolysate For placebo comparator, a combination of sweetener + aroma, which was equal to the combination used in the intervention period, was given Dietary Supplement: Placebo A combination of sweetener + aroma , which was equal to the combination used in the intervention period, was given. Receives: Dietary Supplement: NWT-03, an egg-white protein hydrolysate; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in carotid-radial pulse wave velocity (cr-PWV)
Assess the acute (2 hours) and short term (2 days and 4 week) effects of daily administration of 5g of NWT-03 on carotid radial Pulse Wave Velocity (cr-PWV)
Measured: 2 hours, 2 days and 4 weeks
Secondary outcomes (11)
Change in carotid-femoral Pulse Wave Velocity (cf-PWV)
Assess the acute (2 hours) and short term (2 days and 4 week) effects of daily administration of 5g of NWT-03 on carotid femoral Pulse Wave Velocity (cf-PWV)
Measured: 2 hours, 2 days and 4 weeks
Change in characteristics of microcirculation as measured by fundus photography
Assess the acute (2 hours) and short term (2 days and 4 week) effects of daily administration of 5g of NWT-03 on characteristics of microcirculation as measured by fundus photography
Measured: 2 hours, 2 days and 4 weeks
Change in Systolic Blood Pressure
Assess the acute (2 hours) and short term (2 days and 4 week) effects of daily administration of 5g of NWT-03 on Systolic Blood Pressure
Measured: 2 hours, 2 days and 4 weeks
Change in Diastolic Blood Pressure
Assess the acute (2 hours) and short term (2 days and 4 week) effects of daily administration of 5g of NWT-03 on Diastolic Blood Pressure
Measured: 2 hours, 2 days and 4 weeks
Change in incretins
Assess the short term (4 weeks) effects of daily administration of 5g NWT-03 on incretins (GLP-1, GLP-2, PYY)
Measured: 4 weeks
Change in serum HDL cholesterol concentration
Assess the short term (4 weeks) effects of daily administration of 5g NWT-03 on serum HDL cholesterol concentration
Measured: 4 weeks
Change in serum total cholesterol concentration
Assess the short term (4 weeks) effects of daily administration of 5g NWT-03 on serum total cholesterol concentration
Measured: 4 weeks
Change in serum LDL cholesterol concentration
Assess the short term (4 weeks) effects of daily administration of 5g NWT-03 on serum LDL cholesterol concentration
Measured: 4 weeks
Change in serum triacylglycerol concentration
Assess the short term (4 weeks) effects of daily administration of 5g NWT-03 on serum triacylglycerol concentration
Measured: 4 weeks
Change in glucose concentration
Assess the short term (4 weeks) effects of daily administration of 5g NWT-03 on glucose concentration
Measured: 4 weeks
Change in insulin concentration
Assess the short term (4 weeks) effects of daily administration of 5g NWT-03 on insulin concentration
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionSep 2017
- Study completionSep 2017
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 Metabolic SyndromeStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newtricious R&D BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Maastricht University
- Responsible party
- Sponsor
- Investigators
- Jogchum Plat, PhD, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02561663
- Sponsor's protocol ID
- NWT-03 Pivotal 2
- Status last verified
- Jan 2018
- First submitted
- 17 Jul 2015
- Last updated
- 3 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Nijssen KMR, Joris PJ, Mensink RP, Plat J. Longer-term effects of the egg-protein hydrolysate NWT-03 on arterial stiffness and cardiometabolic risk markers in adults with metabolic syndrome: a randomized, double-blind, placebo-controlled, crossover trial. Eur J Clin Nutr. 2023 Oct;77(10):982-988. doi: 10.1038/s41430-023-01305-8. Epub 2023 Jul 7.
PubMed 37419971Gravesteijn E, Adam JJ, Mensink RP, Winkens B, Plat J. Effects of the egg protein hydrolysate NWT-03 on cognitive function in men and women with the metabolic syndrome: a randomized, double-blind, placebo-controlled study. Nutr Neurosci. 2023 Dec;26(12):1212-1221. doi: 10.1080/1028415X.2022.2144204. Epub 2022 Nov 14.
PubMed 36373820
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo Controlled, Crossover Study to Determine the Effect of 5g Egg Protein Hydrolysate (NWT-03) on Arterial Stiffness, Microcirculation and Blood Pressure in Otherwise Healthy Subjects With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT02561663
- Acronym / sponsor ID
- NWT-03 Pivotal 2
- Conditions
- Metabolic Syndrome
- Keywords
- microcirculation, blood pressure, pulse wave analysis, pulse wave velocity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Newtricious R&D BVIndustry (pharma, biotech, devices)
- Collaborators
- Maastricht University
- Study start
- Aug 2015 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 28 Sep 2015 (estimated)
- 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.
Rationale: Subjects with the metabolic syndrome have an increased risk of developing cardiovascular disease and a twofold risk of developing hypertension. A functional food ingredient with the ability to improve arterial stiffness, microcirculation and/or the ability to reduce blood pressure could potentially contribute to the delay or prevention of a range of cardiovascular diseases and could provide additional complimentary alternatives to pharmacological and lifestyle based interventions in the maintenance of cardiovascular health.
Objective: To assess the acute (2h) and short term (2 days and 4 week) effects of daily administration of 5g of NWT03 (an egg-protein hydrolysate) on carotid-radial Pulse Wave Velocity (cr-PWV). Secondary objectives are to assess its effects on carotid-femoral PWV, characteristics of microcirculation, systolic and diastolic blood pressure, lipid and lipoprotein metabolism, glucose metabolism and incretins.
Study design: Investigators propose to carry out a randomized, double-blind, placebo controlled crossover study.
Study population: Eligible subjects will be male or female, non-smokers between 18-75 years of age and will be otherwise healthy, but meeting at least three criteria of the Metabolic Syndrome (MetS). It is estimated that 80 otherwise healthy subjects with MetS will be randomised, to result in a minimum of 72 evaluable subjects (drop out maximal 10%) at the end of the study.
Intervention: Subjects will be randomly allocated to receive 5g of NWT-03 and placebo, once daily, on separate occasions, for a period of 4 weeks and with a washout period between the two interventions of typically 4 weeks. However, this period may be shortened by 2 weeks or extended by 8 weeks, depending on the availability of the subject. Total study duration will be 10 - 16 weeks, depending on the duration of the washout period.
Main study parameters/endpoints: Measurements will be performed at the start and end of each 4-week intervention period. Effects of NWT-03 supplementation will be calculated as the absolute differences between values obtained at each period. The main study endpoint is the change in cr-PWV.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Before the study starts, subjects will be screened to determine eligibility during a screening visit. During this visit, body weight, height, waist circumference and blood pressure will be measured and a venous blood sample (10 mL) will be collected. During the study, subjects will receive NWT-03 and placebo powders in random order and are asked to consume it on a daily basis. At visits 2, 3, 4, 5, 6 and 7 (days 0, 2, 27, 56, 58 and 83 of the study), cr-PWV, cf-PWV and office blood pressure will be recorded. A fundus photograph and a blood sample (20mL) will be taken in fasting condition. 2 hours after intake of the designated study product cr-PWV, cf-PWV and office blood pressure will again be measured and another fundus photograph will be taken. Additionally, a blood sample (20 mL) will be collected. Thus, in total 270 mL blood will be drawn. A pregnancy test will be taken in females of childbearing potential at visits 2 and 5. Subjects will be asked to fill out a food frequency questionnaire and to provide a spot urine sample at visits 4 and 7. Furthermore, subjects will be asked to keep a study diary throughout the duration of the study. Total time investment for the subjects will be approximately 19 hours. Apart from bruises or hematoma, rarely induced by blood sampling, no risks are associated with participation in this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NWT-03, followed by placebo | Experimental | Dietary Supplement: NWT-03, an egg-white protein hydrolysate, Other: PlaceboDietary Supplement: NWT-03, an egg-white protein hydrolysate For placebo comparator, a combination of sweetener + aroma, which was equal to the combination used in the intervention period, was given Dietary Supplement: Placebo A combination of sweetener + aroma , which was equal to the combination used in the intervention period, was given. |
| Placebo, followed by NWT-03 | Experimental | Dietary Supplement: NWT-03, an egg-white protein hydrolysate, Other: PlaceboDietary Supplement: NWT-03, an egg-white protein hydrolysate For placebo comparator, a combination of sweetener + aroma, which was equal to the combination used in the intervention period, was given Dietary Supplement: Placebo A combination of sweetener + aroma , which was equal to the combination used in the intervention period, was given. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- To be considered eligible for enrolment into the study, subjects must;
- Be able to give written informed consent,
- Be between 18 and 75 years of age,
- Be in generally good health as determined by the investigator,
- Be non-smokers
Key exclusion criteria (14 listed)
- Subjects will be excluded from the study if they meet any of the below criteria;
- Are less than 18 years of age or over 75 years of age,
- Females who are pregnant, breast feeding or who may wish to become pregnant during the study,
- Are hypersensitive to any of the components of the test product (i.e. egg protein),
- Have a significant acute or chronic coexisting illness such as cardiovascular disease, chronic kidney disease (CKD), gastrointestinal disorder, endocrinological disorder, immunological disorder, metabolic disease or any condition which contraindicates, in the investigators judgement, entry to 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 |
|---|---|---|
| NWT-03, an egg-white protein hydrolysateegg-white protein hydrolysate | Dietary supplement | NWT-03, followed by placebo, Placebo, followed by NWT-03 |
| Placebo | Other | NWT-03, followed by placebo, Placebo, followed by NWT-03 |
Primary outcome
Change in carotid-radial pulse wave velocity (cr-PWV)
Time frame: 2 hours, 2 days and 4 weeks
Assess the acute (2 hours) and short term (2 days and 4 week) effects of daily administration of 5g of NWT-03 on carotid radial Pulse Wave Velocity (cr-PWV)
11 secondary outcomes
Change in carotid-femoral Pulse Wave Velocity (cf-PWV)
Time frame: 2 hours, 2 days and 4 weeks
Change in characteristics of microcirculation as measured by fundus photography
Time frame: 2 hours, 2 days and 4 weeks
Change in Systolic Blood Pressure
Time frame: 2 hours, 2 days and 4 weeks
Change in Diastolic Blood Pressure
Time frame: 2 hours, 2 days and 4 weeks
Change in incretins
Time frame: 4 weeks
Change in serum HDL cholesterol concentration
Time frame: 4 weeks
Change in serum total cholesterol concentration
Time frame: 4 weeks
Change in serum LDL cholesterol concentration
Time frame: 4 weeks
Change in serum triacylglycerol concentration
Time frame: 4 weeks
Change in glucose concentration
Time frame: 4 weeks
Change in insulin concentration
Time frame: 4 weeks
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 3 Jan 2018.
- Derived from this study: PubMed 37419971Nijssen KMR, Joris PJ, Mensink RP, Plat J. Longer-term effects of the egg-protein hydrolysate NWT-03 on arterial stiffness and cardiometabolic risk markers in adults with metabolic syndrome: a randomized, double-blind, placebo-controlled, crossover trial. Eur J Clin Nutr. 2023 Oct;77(10):982-988. doi: 10.1038/s41430-023-01305-8. Epub 2023 Jul 7.
- Derived from this study: PubMed 36373820Gravesteijn E, Adam JJ, Mensink RP, Winkens B, Plat J. Effects of the egg protein hydrolysate NWT-03 on cognitive function in men and women with the metabolic syndrome: a randomized, double-blind, placebo-controlled study. Nutr Neurosci. 2023 Dec;26(12):1212-1221. doi: 10.1080/1028415X.2022.2144204. Epub 2022 Nov 14.
Related trials for Metabolic Syndrome
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingObservational study
Long-Term Follow-Up of Survivors of Pediatric Cushing Disease
Cushing Disease
Recruiting
Multi-omics Dissection of Gut Microbiome Engraftment During FMT
Recurrent C. Difficile (rCDI), Ulcerative Colitis (UC)
RecruitingObservational study
Study of the Effect of Innate on the Inflammatory Response to Endotoxin
Asthma, Atherosclerosis
RecruitingObservational study
Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
Frontotemporal Dementia, Amyotrophic Lateral Sclerosis
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.
Jogchum Plat, PhD principal investigator
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NWT-03, an egg-white protein hydrolysate in people with Metabolic Syndrome, run by Newtricious R&D BV at 1 site in Netherlands.
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 12 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 3 Jan 2018. 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 Netherlands. 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. 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 carotid-radial pulse wave velocity (cr-PWV) (time frame: 2 hours, 2 days and 4 weeks). 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 NCT02561663, 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 3 Jan 2018.