Effect of NWT-03 on Blood Pressure

NCT02144740 | Completed

• 1 other identifier: AFCRO-041 - Part 2
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Blood Pressure; Albuminuria

Keywords

Flow-mediated dilation

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (3)

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

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

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

  Both periods: at baseline and after 8 weeks

• Change from 48 before baseline in albuminuria at 8 weeks

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

Other Outcomes (2)

• Vitals (weight, height, BMI)

  During screening (up to 4 weeks before baseline)

• eGFR

  Each period: 48h before baseline and week 8

Study Arms (2)

NWT-03, then placebo

OTHER

4 weeks 2g NWT-03 followed by placebo , separated by a 4wk wash-out period

Dietary Supplement: NWT-03, an egg-white protein hydrolysate; Dietary Supplement: Placebo

Placebo, then NWT-03

OTHER

4 weeks placebo followed by 2g NWT-03, separated by a 4wk wash-out period

Dietary Supplement: NWT-03, an egg-white protein hydrolysate; Dietary Supplement: Placebo

Interventions

NWT-03, an egg-white protein hydrolysate DIETARY_SUPPLEMENT

For placebo comparator, a combination of sweetener + aroma, which was equal to the combination used in the intervention period, was given

NWT-03, then placebo; Placebo, then NWT-03

Placebo DIETARY_SUPPLEMENT

A combination of sweetener + aroma , which was equal to the combination used in the intervention period, was given.

NWT-03, then placebo; Placebo, then NWT-03

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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,
• 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,

Sponsors & Collaborators

• Newtricious R&D BV: lead

Study Sites (1)

Atlantia Food CRO

Cork, Ireland

Location

MeSH Terms

Conditions

Albuminuria

Interventions

NWT-03

Condition Hierarchy (Ancestors)

Proteinuria; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2013
• First Posted: May 22, 2014
• Study Start: October 1, 2013
• Primary Completion: April 1, 2014
• Last Updated: May 23, 2014

Record last verified: 2014-05

Locations

IE (1)