Viewing Study NCT06555393



Ignite Creation Date: 2024-10-26 @ 3:37 PM
Last Modification Date: 2024-10-26 @ 3:37 PM
Study NCT ID: NCT06555393
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2024-08-12

Brief Title: Understanding the Health Effect of a Bioactive Peptide From Egg A Pilot Study
Sponsor: None
Organization: None

Study Overview

Official Title: A Preliminary Human Study on Bioavailability and Efficacy of Bioactive Peptide IRW in Egg White Hydrolysate
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Bioactive peptides derived from food proteins show potential for improving human health One of such promising peptides is namely IRW made from egg white hydrolysate and composed of three peptides This is a feasibility study to assess the acute effect of IRW in egg white hydrolysate for the management of high sugar and blood pressure

Participants at high risk of type 2 diabetes T2D or having T2D will undergo 4 consecutive treatments of 1 day each randomly during which they will consume a standardized breakfast with a smoothie containing different protein powders Each treatment will be separated by a minimum of 1-week

Participants in the healthy control group will undergo 1 treatment only one day
Detailed Description: Bioactive peptides derived from food proteins show vast potential for improving human health in addition to providing nutritional value One of such promising peptides is a short tripeptide IRW made of three amino acids isoleucine-arginine-tryptophan the first discovered peptide that can activate ACE2 angiotensin converting enzyme 2 preclinically ACE2 is best known as the entry receptor of some coronaviruses including the pandemics SARS-CoV-2 while the primary role of ACE2 is to provide protection on the cardiometabolic system Therefore activation of ACE2 is a novel strategy to mitigate cardiometabolic diseases A decade-long collaborative research on IRW has established a large body of knowledge about IRWs health effects on hypertension type-2 diabetes T2Dinsulin resistance IR oxidation and inflammation To translate the knowledge for human applications it is essential to investigate the bioavailability and efficacy of bioactive peptide IRW in egg white hydrolysate

IRW is derived from ovotransferrin which accounts for 12 of total egg white protein Egg white powder without a process of hydrolyzation will not liberate the IRW therefore this will be used as a negative control However it is too costly to prepare IRW from pure ovotransferrin for functional food applications To reduce the cost of production whole egg white could be used as the starting material IRW can only be released by a combination of thermolysin and pepsin If only thermolysin is applied a pentapeptide IRWCT is formed as pepsin is naturally secreted in the stomach egg white hydrolysate will be prepared using thermolysin It is expected that IRW will be released in vivo by the gastrically secreted pepsin

This study is the first to translate a peptide ACE2 activator as a functional food for human applications against metabolic syndrome MetS hypertension T2DInsulin Resistance A functional food containing IRW provides a dietary strategy for the mitigation of metabolic syndrome and presents a value-added opportunity for the Canadian egg industry

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None