An interventional study of NWT-03, an egg-white protein hydrolysate and Placebo in Metabolic Syndrome, sponsored by Newtricious R&D BV. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-03.
Sponsored by Newtricious R&D BV · Not applicable, Interventional, and Prevention
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.
1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.
This study's enrollment of 79 is above the median of 60 across 1,460 interventional studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →Newtricious R&D BV is the lead sponsor of 4 studies on the registry; none are open to participants now.
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To be considered eligible for enrolment into the study, subjects must;
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:
Exclusion Criteria:
Subjects will be excluded from the study if they meet any of the below criteria;
Dietary Supplement: NWT-03, an egg-white protein hydrolysate For placebo comparator, a combination of sweetener + aroma, which was equal to the combination used in the intervention period, was given Dietary Supplement: Placebo A combination of sweetener + aroma , which was equal to the combination used in the intervention period, was given.
Dietary Supplement: NWT-03, an egg-white protein hydrolysate · Other: Placebo
Dietary Supplement: NWT-03, an egg-white protein hydrolysate For placebo comparator, a combination of sweetener + aroma, which was equal to the combination used in the intervention period, was given Dietary Supplement: Placebo A combination of sweetener + aroma , which was equal to the combination used in the intervention period, was given.
Dietary Supplement: NWT-03, an egg-white protein hydrolysate · Other: Placebo
egg-white protein hydrolysate
Change in carotid-radial pulse wave velocity (cr-PWV)
Assess the acute (2 hours) and short term (2 days and 4 week) effects of daily administration of 5g of NWT-03 on carotid radial Pulse Wave Velocity (cr-PWV)
Time frame: 2 hours, 2 days and 4 weeks
Change in carotid-femoral Pulse Wave Velocity (cf-PWV)
Assess the acute (2 hours) and short term (2 days and 4 week) effects of daily administration of 5g of NWT-03 on carotid femoral Pulse Wave Velocity (cf-PWV)
Time frame: 2 hours, 2 days and 4 weeks
Change in characteristics of microcirculation as measured by fundus photography
Assess the acute (2 hours) and short term (2 days and 4 week) effects of daily administration of 5g of NWT-03 on characteristics of microcirculation as measured by fundus photography
Time frame: 2 hours, 2 days and 4 weeks
Change in Systolic Blood Pressure
Assess the acute (2 hours) and short term (2 days and 4 week) effects of daily administration of 5g of NWT-03 on Systolic Blood Pressure
Time frame: 2 hours, 2 days and 4 weeks
Change in Diastolic Blood Pressure
Assess the acute (2 hours) and short term (2 days and 4 week) effects of daily administration of 5g of NWT-03 on Diastolic Blood Pressure
Time frame: 2 hours, 2 days and 4 weeks
Change in incretins
Assess the short term (4 weeks) effects of daily administration of 5g NWT-03 on incretins (GLP-1, GLP-2, PYY)
Time frame: 4 weeks
Change in serum HDL cholesterol concentration
Assess the short term (4 weeks) effects of daily administration of 5g NWT-03 on serum HDL cholesterol concentration
Time frame: 4 weeks
Change in serum total cholesterol concentration
Assess the short term (4 weeks) effects of daily administration of 5g NWT-03 on serum total cholesterol concentration
Time frame: 4 weeks
Change in serum LDL cholesterol concentration
Assess the short term (4 weeks) effects of daily administration of 5g NWT-03 on serum LDL cholesterol concentration
Time frame: 4 weeks
Change in serum triacylglycerol concentration
Assess the short term (4 weeks) effects of daily administration of 5g NWT-03 on serum triacylglycerol concentration
Time frame: 4 weeks
Change in glucose concentration
Assess the short term (4 weeks) effects of daily administration of 5g NWT-03 on glucose concentration
Time frame: 4 weeks
Change in insulin concentration
Assess the short term (4 weeks) effects of daily administration of 5g NWT-03 on insulin concentration
Time frame: 4 weeks
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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