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

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 90

Inclusion Criteria

To be considered eligible for enrolment into the study, subjects must;
1. Be able to give written informed consent,
2. Be between 18 and 75 years of age,
3. Be in generally good health as determined by the investigator,
4. Be non-smokers
5. Have a stable body weight (< 5% change) in the 3 months prior to study entry,
6. 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)

Exclusion Criteria

Subjects will be excluded from the study if they meet any of the below criteria;
1. Are less than 18 years of age or over 75 years of age,
2. Females who are pregnant, breast feeding or who may wish to become pregnant during the study,
3. Are hypersensitive to any of the components of the test product (i.e. egg protein),
4. 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,
5. 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.
6. Are taking non-steroidal anti-inflammatory drugs (NSAIDs) within 2 weeks of baseline visit or for the duration of the trial,
7. Suffer from diabetes mellitus, either type I and type II,
8. Consume more than the recommended alcohol guidelines i.e. >21 alcohol units/week for males and >14 units/week for females,
9. History of illicit drug use,
10. 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,
11. Subjects may not be receiving treatment involving experimental drugs,
12. If the subject has been in a recent experimental trial, these must have been completed not less than 30 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.
13. Have a malignant disease or any concomitant end-stage organ disease,

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Measurements will be performed at the start and end of each 4-week intervention<br /><br>period. Effects of NWT-03 supplementation will be calculated as the absolute<br /><br>differences between values obtained at each period. The main study endpoint is<br /><br>the change in cr-PWV.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study outcomes are as follows:<br /><br>* Assess the acute (2 hours) and short term (2 days and 4 week) effects of<br /><br>daily administration of 5g of NWT-03 on carotid femoral Pulse Wave Velocity<br /><br>(cf-PWV)<br /><br>* Assess the acute (2 hour) and short term (2 days and 4 week) effects of daily<br /><br>administration of 5g dose of NWT-03 on characteristics of microcirculation as<br /><br>measured by fundus photography<br /><br>* Assess the acute (2 hour) and short term (4 week) effects of daily<br /><br>administration of 5g doses of NWT-03 on Systolic & Diastolic Blood Pressure<br /><br>* Assess the short term (4 weeks) effects of daily administration of 5g NWT-03<br /><br>on lipid and lipoprotein metabolism (cholesterol and triacylglycerol levels),<br /><br>glucose metabolism (glucose and insulin) and incretins (GLP-1, GLP-2, PYY) </p><br>