A Phase 1 interventional study of Egg White Powder in High Blood Sugar, High Blood Pressure and Overweight and Obesity, sponsored by University of Alberta. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by University of Alberta · Phase 1, Interventional, and Treatment
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).
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 pandemic's 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 IRW's health effects on hypertension, type-2 diabetes (T2D)/insulin 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, T2D/Insulin 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.
800 studies on the registry are indexed under Hyperglycemia; 115 are open to participants now.
This study's planned enrollment of 28 is below the median of 50 across 620 interventional studies indexed under Hyperglycemia.
Browse Hyperglycemia studies →University of Alberta is the lead sponsor of 823 studies on the registry; 169 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Healthy control group:
Individuals at risk of diabetes/having type 2 diabetes:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
20 g of egg white powder from the market; negative control; only individuals at risk of diabetes/having type 2 diabetes.
Dietary Supplement: Egg White Powder
5 g; dose based on human equivalent dose calculation; only individuals at risk of diabetes/having type 2 diabetes
Dietary Supplement: Egg White Powder
20 g; dose based on energy percentage used in animal experiment; both healthy control group and at risk of diabetes/having type 2 diabetes
Dietary Supplement: Egg White Powder
20 g; positive control, only individuals at risk of diabetes/having type 2 diabetes
Dietary Supplement: Egg White Powder
Participants will consume a standardized breakfast (2 slices of 70 g whole wheat bread, 10 g of butter and 30 g of strawberry jam) followed by a smoothie containing the powder. The Egg White Powder will be incorporated in the standardized smoothie containing water, fruits and chocolate/strawberry syrup totaling 250 Kcal. The total calories of the breakfast will be adapted to the calorie needs of each participant to account for 20-25% of their daily calorie intake. After a 9 h fast, blood will be taken before consumption of the standardized breakfast and smoothie (T= 0) and at 5, 10, 20, 30, 60, 90, 120, and 180 min after consumption of the smoothie. Participants will be given 15-25 minutes to eat their breakfast. Urine samples will be collected from participants before the smoothie consumption (0 h) and at 30 min, 90 min, 150 min, 6 hours, 12 hours, and 24 hours following consumption.
Plasma Peptide concentration (IRW) overtime
iAUC for the plasma peptide concentration (IRW) after the test treatments compared to negative control smoothie
Time frame: 5, 10, 20, 30, 60, 90, 120, and 180 minutes after consumption of the smoothie
Plasma glucose over time
iAUC for plasma glucose (up to T= 180 minutes)
Time frame: 30, 60, 90, 120, and 180 minutes after consumption of the smoothie
Plasma Insulin over time
iAUC for plasma insulin (up to T=180 minutes)
Time frame: 30, 60, 90, 120, and 180 minutes after consumption of the smoothie
Blood pressure over time
Acute effect on blood pressure during the intervention
Time frame: 60, 120, and 180 minutes after consumption of the smoothie
Started Feb 2026 (actual). Primary completion is estimated for Jan 2027, 11 months after the start.
Of 17 phase 1 interventional studies under Hyperglycemia, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's planned 11 months is below that.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 26, 2026: primary completion Sep 2026 → Jan 2027 and completion Oct 2026 → Jan 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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