|- candidate number||3153|
|- NTR Number||NTR1265|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||29-mrt-2008|
|- Secondary IDs||121920 |
|- Public Title||Blood Pressure Effects of egg white hydrolysate consumed by Untreated Hypertensive Subjects|
|- Scientific Title||Blood Pressure Effects of egg white hydrolysate in Untreated Hypertensive Subjects|
|- hypothesis||The primary objective of this study is to establish a blood pressure reduction by supplementing hypertensive subjects with an egg white hydrolysate (3g of peptides) and measuring the effects against a placebo.|
|- Healt Condition(s) or Problem(s) studied||Hypertension, Egg white hydrolysate|
|- Inclusion criteria||1. Blood pressure >130 mm Hg (systolic) and >80 mm Hg (diastolic) |
2. Not taking any concomitant medication
3. Otherwise healthy
4. Alcohol consumption <14 units/week for women and <21 units/week for men
5. Aged 35-70 years
|- Exclusion criteria||1. Participation in any other clinical trial including blood sampling and/or administration of substances up to 90 days before day 1 of this study.|
2. Mental status that is incompatible with the proper conduct of the study.
3. Reported unexplained weight loss or gain (>2 kg) in the last month before screening.
4. Females who are pregnant/lactating or planning to become pregnant during the study period.
5. Have a proven allergy toward egg derived products.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||31-mrt-2008|
|- planned closingdate||13-aug-2008|
|- Target number of participants||30|
|- Interventions||Daily consumption of a single dose of either egg white hydrolysate or placebo over six weeks. After a six weeks of wash out the six week cross-over treatment will be consumed.|
|- Primary outcome||To establish a significant blood pressure reduction by providing subjects with supplements of an egg white hydrolysate.|
|- Secondary outcome||Effect on serum cholesterol levels|
|- Timepoints||Six weeks of treatment, six weeks of wash out and six weeks of cross-over treatment.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Hans Saag, van der|
|- CONTACT for SCIENTIFIC QUERIES|| Aimee Matthews|
|- Sponsor/Initiator ||Bio-Actor BVBA|
(Source(s) of Monetary or Material Support)
|- Publications||A. Dávalos et.al., Antioxidant activity of peptides derived from egg white proteins by enzymatic hydrolysis, J. Food Prot (2004), 67 (9) 1939-1944. |
Miguel. M. et.al., Short-term effect of egg-white hydrolysate products on the arterial blood pressure of hypertensive rats. Br J Nutr. (2005), 94(5):731-7.
Miguel, M. et.al., Long-term intake of egg white hydrolysate attenuates the development of hypertension in spontaneously hypertensive rats, Life Sci., (2005), Dec. 27.
Miguel, M. et.al., Effect of simulated gastrointestinal digestion on the antihypertensive properties of ACE-inhibitory peptides derived from ovalbumin, J Agric Food Chem., (2006), 54(3), 726-731.
Miguel, M. et.al., Vasodilatory effects of peptides derived from egg white proteins, Regulatory peptides, (2007), 140, 131-135.
Miguel, M. et.al., Angiotensin-converting enzyme activity in plasma and tissues of spontaneously hypertensive rats after short- and long-term intake of hydrolysed egg white, Mol. Nutr. Food Res. (2007), 51, 555-563
Miguel, M. et.al. Antihypertensive, ACE-inhibitory and vasodilator properties of an egg white hydrolysate: effect of a simulated intestinal digestion, Food Chemistry (2007), 104, 163-168
|- Brief summary||N/A|
|- Main changes (audit trail)|
|- RECORD||29-mrt-2008 - 5-jun-2008|