Blood PressureNCT02148198
Effect of NWT-03 on Blood Pressure - Part 1
A study testing NWT-03, an egg-white protein hydrolysate in people with Blood Pressure, run by Newtricious R&D BV.
Trial summary
Part 1 of the study will assess the effect of 1g, 2g and 5g doses of NWT-03 on systolic and diastolic blood pressure in a cross-over designed study in healthy adults with normal, high normal and mild hypertension. Read more about this study
- Who is it for?
- Ages 35 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- 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
- 92 participants
- Where
- No sites listed yet
- Study dates
- May 2013to Jul 2013
- 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 35 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be able to give written informed consent,
- Be between 35 and 75 years of age,
- Be in generally good health as determined by the investigator,
- Smokers and non-smokers are eligible,
- Have a stable body weight (< 5% change) over the past 3-months,
- Have a Body Mass Index (BMI) between 25 and 35 kg/m2,
- Be: (a) Normotensive (Systolic Blood Pressure <130 mmHg \& Diastolic Blood Pressure <85 mmHg), (b) High normotensive (Systolic Blood Pressure 130-139 mmHg \& Diastolic Blood Pressure 85-89 mmHg) or (c) Mild hypertensive (Systolic Blood Pressure 140-159 mmHg \& Diastolic Blood Pressure 90-99 mmHg).
Who cannot join
- Are less than 35 and greater than 75 years of age,
- Females are pregnant, lactating or wish to become pregnant during the study.
- Are hypersensitive to any of the components of the test product,
- 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 medication and medication interfering with renin-angiotensin-aldosterone system (RAAS), such as ACE-inhibitors, angiotensin receptor blockers, direct renin inhibitors or aldosterone receptor inhibitor,
- Are taking non-steroidal anti-inflammatory drugs (NSAIDs) within 2 weeks of baseline visit or for the duration of the trial,
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- 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,
- Use of nasal decongestants and other over-the counter or herbal preparation within 2 weeks of baseline visit and for the duration of the trial,
- Heavy intake of coffee (i.e. more that 4 cups daily) within 2 weeks of baseline visit and for the duration of the trial,
- 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. An exception will be made where subjects have participated in part 1 of the study,
- Have a malignant disease or any concomitant end-stage organ disease,
About this study
Official title: A Study of Two Parts to Determine the Effect of NWT-03 on Blood Pressure in Healthy Subjects. Part 1: A Dose Ranging, Cross-over Study to Determine the Effect of 1g, 2g & 5gs of NWT-03 Versus Placebo on Blood Pressure in Healthy Subjects.
Part 1 of the study will assess the effect of 1g, 2g and 5g doses of NWT-03 on systolic and diastolic blood pressure in a cross-over designed study in healthy adults with normal, high normal and mild hypertension. Based on results from this study, one dose will be selected for a placebo controlled parallel study assessing a single dose of NWT-03 on systolic and diastolic blood pressure and endothelial function in a similar population.
- Conditions
- Blood Pressure
- Being tested
- NWT-03, an egg-white protein hydrolysate, Placebo
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
For placebo comparator, a combination of sweetener + aroma, which was equal to the combination used in the intervention period, was given
PlaceboDietary supplement
A combination of sweetener + aroma, which was equal to the combination used in the intervention period was given as placebo comparator.
| Study group | Role | What they receive |
|---|---|---|
| 1g NWT-03, then placebo | Active comparator | 7 days 1g NWT-03, followed by 7 days placebo, separated by a 5-day wash-out period Receives: Dietary Supplement: NWT-03, an egg-white protein hydrolysate; Dietary Supplement: Placebo |
| placebo, then 1g NWT-03 | Placebo comparator | 7 days placebo, followed by 7days 1g NWT-03, separated by a 5-day wash-out period Receives: Dietary Supplement: NWT-03, an egg-white protein hydrolysate; Dietary Supplement: Placebo |
| 2g NWT-03, then placebo | Active comparator | 7 days 2g NWT-03, followed by 7 days placebo, separated by a 5-day wash-out period Receives: Dietary Supplement: NWT-03, an egg-white protein hydrolysate; Dietary Supplement: Placebo |
| placebo, then 2g NWT-03 | Placebo comparator | 7 days placebo, followed by 7days 2g NWT-03, separated by a 5-day wash-out period Receives: Dietary Supplement: NWT-03, an egg-white protein hydrolysate; Dietary Supplement: Placebo |
| 5g NWT-03, then placebo | Active comparator | 7 days 5g NWT-03, followed by 7 days placebo, separated by a 5-day wash-out period Receives: Dietary Supplement: NWT-03, an egg-white protein hydrolysate; Dietary Supplement: Placebo |
| placebo, then 5g NWT-03 | Placebo comparator | 7 days 5g NWT-03, followed by 7 days placebo, separated by a 5-day wash-out period Receives: Dietary Supplement: NWT-03, an egg-white protein hydrolysate; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in average daytime systolic blood pressure at 5 days
Blood pressure will be measured two times for 48h during each intervention period; 48h before the baseline measurement and 5 days after baseline measurement.
Measured: For both intervention periods: 48h ABPM before baseline visit and 5 days after baseline visit
Secondary outcomes (3)
Change from baseline in average daytime diastolic blood pressure at 5 days
Blood pressure will be measured two times for 48h during each intervention period; 48h before the baseline measurement and 5 days after baseline measurement.
Measured: 48h ABPM before baseline visit and 5 days after baseline visit
Change from baseline in 48h systolic blood pressure at 5 days
Blood pressure will be measured two times for 48h during each intervention period; 48h before the baseline measurement and 5 days after baseline measurement.
Measured: 48h ABPM before baseline visit and 5 days after baseline visit
Change from baseline in 48h diastolic blood pressure at 5 days
Blood pressure will be measured two times for 48h during each intervention period; 48h before the baseline measurement and 5 days after baseline measurement.
Measured: 48h ABPM before baseline visit and 5 days after baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study startMay 2013
- Primary completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies 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
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newtricious R&D BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph Eustace, PhD, Principal investigator, University College Cork
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02148198
- Sponsor's protocol ID
- AFCRO-041-part 1
- Status last verified
- May 2014
- First submitted
- 6 Nov 2013
- Last updated
- 28 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Two Parts to Determine the Effect of NWT-03 on Blood Pressure in Healthy Subjects. Part 1: A Dose Ranging, Cross-over Study to Determine the Effect of 1g, 2g & 5gs of NWT-03 Versus Placebo on Blood Pressure in Healthy Subjects.
- ClinicalTrials.gov ID
- NCT02148198
- Acronym / sponsor ID
- AFCRO-041-part 1
- Conditions
- Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Newtricious R&D BVIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Jul 2013 (actual)
- First posted
- 28 May 2014 (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.
Part 1 of the study will assess the effect of 1g, 2g and 5g doses of NWT-03 on systolic and diastolic blood pressure in a cross-over designed study in healthy adults with normal, high normal and mild hypertension. Based on results from this study, one dose will be selected for a placebo controlled parallel study assessing a single dose of NWT-03 on systolic and diastolic blood pressure and endothelial function in a similar population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1g NWT-03, then placebo | Active comparator | Dietary Supplement: NWT-03, an egg-white protein hydrolysate, Dietary Supplement: Placebo7 days 1g NWT-03, followed by 7 days placebo, separated by a 5-day wash-out period |
| placebo, then 1g NWT-03 | Placebo comparator | Dietary Supplement: NWT-03, an egg-white protein hydrolysate, Dietary Supplement: Placebo7 days placebo, followed by 7days 1g NWT-03, separated by a 5-day wash-out period |
| 2g NWT-03, then placebo | Active comparator | Dietary Supplement: NWT-03, an egg-white protein hydrolysate, Dietary Supplement: Placebo7 days 2g NWT-03, followed by 7 days placebo, separated by a 5-day wash-out period |
| placebo, then 2g NWT-03 | Placebo comparator | Dietary Supplement: NWT-03, an egg-white protein hydrolysate, Dietary Supplement: Placebo7 days placebo, followed by 7days 2g NWT-03, separated by a 5-day wash-out period |
| 5g NWT-03, then placebo | Active comparator | Dietary Supplement: NWT-03, an egg-white protein hydrolysate, Dietary Supplement: Placebo7 days 5g NWT-03, followed by 7 days placebo, separated by a 5-day wash-out period |
| placebo, then 5g NWT-03 | Placebo comparator | Dietary Supplement: NWT-03, an egg-white protein hydrolysate, Dietary Supplement: Placebo7 days 5g NWT-03, followed by 7 days placebo, separated by a 5-day wash-out period |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Be able to give written informed consent,
- Be between 35 and 75 years of age,
- Be in generally good health as determined by the investigator,
- Smokers and non-smokers are eligible,
- Have a stable body weight (< 5% change) over the past 3-months,
Key exclusion criteria (15 listed)
- Are less than 35 and greater than 75 years of age,
- Females are pregnant, lactating or wish to become pregnant during the study.
- Are hypersensitive to any of the components of the test product,
- 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 medication and medication interfering with renin-angiotensin-aldosterone system (RAAS), such as ACE-inhibitors, angiotensin receptor blockers, direct renin inhibitors or aldosterone receptor inhibitor,
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 hydrolysateFor placebo comparator, a combination of sweetener + aroma, which was equal to the combination used in the intervention period, was given | Dietary supplement | 1g NWT-03, then placebo, 2g NWT-03, then placebo, 5g NWT-03, then placebo, placebo, then 1g NWT-03, placebo, then 2g NWT-03, placebo, then 5g NWT-03 |
| PlaceboA combination of sweetener + aroma, which was equal to the combination used in the intervention period was given as placebo comparator. | Dietary supplement | 1g NWT-03, then placebo, 2g NWT-03, then placebo, 5g NWT-03, then placebo, placebo, then 1g NWT-03, placebo, then 2g NWT-03, placebo, then 5g NWT-03 |
Primary outcome
Change from baseline in average daytime systolic blood pressure at 5 days
Time frame: For both intervention periods: 48h ABPM before baseline visit and 5 days after baseline visit
Blood pressure will be measured two times for 48h during each intervention period; 48h before the baseline measurement and 5 days after baseline measurement.
3 secondary outcomes
Change from baseline in average daytime diastolic blood pressure at 5 days
Time frame: 48h ABPM before baseline visit and 5 days after baseline visit
Change from baseline in 48h systolic blood pressure at 5 days
Time frame: 48h ABPM before baseline visit and 5 days after baseline visit
Change from baseline in 48h diastolic blood pressure at 5 days
Time frame: 48h ABPM before baseline visit and 5 days after baseline visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2014.
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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.
Joseph Eustace, PhD principal investigator
University College Cork
Questions about this trial
What is this clinical trial studying?
A study testing NWT-03, an egg-white protein hydrolysate in people with Blood Pressure, run by Newtricious R&D BV.
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 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2014. Status can change between updates, so confirm with the study contact before making plans.
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 from baseline in average daytime systolic blood pressure at 5 days (time frame: For both intervention periods: 48h ABPM before baseline visit and 5 days after baseline visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2014.