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Blood PressureNCT02144740

Effect of NWT-03 on Blood Pressure

A study testing NWT-03, an egg-white protein hydrolysate in people with Blood Pressure and Albuminuria, run by Newtricious R&D BV at 1 site in Ireland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Part 2 of the study will assess the effect of 2g of NWT-03 (an egg-white protein hydrolysate) on systolic and diastolic blood pressure and flow-mediated dilation in a crossover designed study in healthy adults with 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, Albuminuria
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
63 participants
Where
1 siteIreland
Study dates
Oct 2013to Apr 2014
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 mild hypertensive (Systolic Blood Pressure 140-159 mmHg \& Diastolic Blood Pressure 80-99 mmHg).

Who cannot join

  • Subjects will be excluded from the study if they meet any of the below criteria;
  • Are less than 35 and greater than 75 years of age,
  • Females are pregnant, lactating or wish to become pregnant during the study. Female subject is currently either of:
  • non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal or any female who is surgically sterilized (via documented hysterectomy or bilateral tubal ligation). (For purposes of this study, postmenopausal is defined as one year without menses), OR
  • child bearing potential, the subject is eligible to enter and participate in this study if she is not lactating and has a negative urine pregnancy test at the screening visit, visit 2 and upon completion of the study at visit 7. The subject must also agree to one of the following methods of contraception:
  • Complete abstinence from intercourse two weeks prior to administration of study drug, throughout the clinical trial, until the completion of follow-up procedures or for two weeks following discontinuation of the study medication in cases where subject discontinues the study prematurely. (Subjects utilizing this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding 2 weeks when they present to the clinic for the Final Visit.) or,
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  • has a male sexual partner who is surgically sterilized prior to the Screen Visit and is the only male sexual partner for that subject or,
  • sexual partner(s) is/are exclusively female or,
  • Oral contraceptives (either combined or progestogen only) with double-barrier method of contraception consisting of spermicide with either condom or diaphragm. (Women of child-bearing potential using an oral contraceptive in combination with a double-barrier method of contraception are required to continue to use this form of contraception for 1 week following discontinuation of study medication).
  • Use of double-barrier contraception, specifically, a spermicide plus a mechanical barrier (e.g. male condom, female diaphragm). The subject must be using this method for at least 1 week following the end of the study or,
  • Use of any intrauterine device (IUD) with published data showing that the highest expected failure rate is less than 1% per year. The subject must have the device inserted at least 2 weeks prior to the first Screen Visit, throughout the study, and 2 weeks following the end of 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,
  • 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 than 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.

Trial locations and contacts

1 site in 1 country.

Ireland1 site

  • Atlantia Food CRO

    Cork

Other trials in Ireland

About this study

Official title: A Study of Two Parts to Determine the Effect of NWT-03 on Blood Pressure in Healthy Subjects

Part 2 of the study will assess the effect of 2g of NWT-03 (an egg-white protein hydrolysate) on systolic and diastolic blood pressure and flow-mediated dilation in a crossover designed study in healthy adults with mild hypertension.

Being tested
NWT-03, an egg-white protein hydrolysate, Placebo
Keywords
Flow-mediated dilation
Medical subject headings
Albuminuria

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.

Study groups in NCT02144740
Study groupRoleWhat they receive
NWT-03, then placeboOther4 weeks 2g NWT-03 followed by placebo , separated by a 4wk wash-out period
Receives: Dietary Supplement: NWT-03, an egg-white protein hydrolysate; Dietary Supplement: Placebo
Placebo, then NWT-03Other4 weeks placebo followed by 2g NWT-03, separated by a 4wk 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.

  1. Change from baseline in daytime systolic blood pressure at 4 and 8 weeks

    Measured: For both intervention periods: 48h ABPM before baseline visit, 4 and 8 weeks after baseline visit

Secondary outcomes (3)

  1. Change from baseline in daytime diastolic blood pressure at 4 and 8 weeks

    Measured: For both intervention periods: 48h ABPM before baseline visit, 4 and 8 weeks after baseline visit

  2. Change from baseline in flow-mediated dilation (only for n=10 subgroup) at 8 weeks

    Measured: Both periods: at baseline and after 8 weeks

  3. Change from 48 before baseline in albuminuria at 8 weeks

    Measured: For each period: 48h before baseline and 8 weeks after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2014 (estimated)
  2. Study startOct 2013
  3. Primary completionApr 2014

Resources

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
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02144740
Sponsor's protocol ID
AFCRO-041 - Part 2
Status last verified
May 2014
First submitted
6 Nov 2013
Last updated
23 May 2014
Results posted
No
Data monitoring committee
No

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 and Albuminuria, run by Newtricious R&D BV at 1 site in Ireland.

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 24 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 23 May 2014. 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 Ireland. 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 from baseline in daytime systolic blood pressure at 4 and 8 weeks (time frame: For both intervention periods: 48h ABPM before baseline visit, 4 and 8 weeks after baseline visit). 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 NCT02144740.

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 23 May 2014.

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