NWT03 and Arterial Stiffness
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

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 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.
    


Intervention name(s): NWT-03, an egg-white protein hydrolysate; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): egg-white protein hydrolysate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: microcirculation; blood pressure; pulse wave analysis; pulse wave velocity