High Blood SugarPhase 1NCT06555393
Understanding the Health Effect of a Bioactive Peptide From Egg: A Pilot Study
A Phase 1 study testing Egg White Powder in people with High Blood Sugar and High Blood Pressure, run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- High Blood Sugar, High Blood Pressure, Overweight and Obesity
- What is being tested?
- Egg White Powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteCanada
- Study dates
- 25 Feb 2026to Jan 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy control group:
- Men and women aged between 18 and 70 years living in Edmonton (or Edmonton area/driving distance).
- Normal weight (BMI below 25 kg/m2 or Asian population below 23 kg/m2 )
- Waist circumference below the following ethnic specific cut offs: Canada / USA: <102 cm men and <88 cm women; Europids, Middle-Eastern, Sub-Saharan African, and Mediterranean: <94 cm men and <80 cm women; Asians, Japanese, South and Central Americans: <90 cm men and <80 cm women
- Fasting glucose <5.6 mmol/L
- HbA1c <5.6 %
Show all 19Show fewer
- Blood pressure <130/85 mmHg
- Triglycerides <1.7 mmol/L
- HDL-Cholesterol >1.03 mmol/L men and >1.29 mmol/L women
- Body weight stable (within 3% fluctuation) for at least 6 months prior to the study
- Individuals who have never smoke, have smoke less than 100 cigarettes in their life or who are long term quitter (quit smoking a year or more ago)
- Individuals at risk of diabetes/having type 2 diabetes:
- Men and women aged between 18 and 70 years living in Edmonton (or Edmonton area/driving distance).
- Overweight or obesity (BMI above 25 kg/m2 or Asian population above 23 kg/m2)
- Waist circumference at or above the following ethnic specific cut offs: Canada / USA: ≥ 102 cm men and ≥ 88 cm women; Europids, Middle-Eastern, Sub-Saharan African, and Mediterranean: ≥ 94 cm men and ≥ 80 cm women; Asians, Japanese, South and Central Americans: ≥ 90 cm men and ≥ 80 cm women
- Fasting glucose ≥ 6.0 mmol/L
- HbA1c ≥ 6.0 %
- Body weight stable (within 3% fluctuation) for at least 6 months prior to the study
- Individuals who have never smoke, have smoke less than 100 cigarettes in their life or who are long term quitter (quit smoking a year or more ago)
Who cannot join
- Individuals with a previous history of CVD, renal disorder, monogenic dyslipidemia, with endocrine disorders other than T2D
- Individuals taking chronic anti-inflammatory drugs (including aspirin, antihistamines, and omega-3 supplements)
- Pregnant/lactating women
- Individuals aged above 70 years
- Smokers (current smokers: daily/occasional and those who have smoked more than 100 cigarettes in their life)
- Individuals with specific nutritional restrictions (e.g. vegetarianism excluding eggs from their diet, vegan or with egg allergy) will be excluded
- Individuals with poorly controlled (HbA1c >12.0%) diabetes or taking exogenous insulin will be excluded. Other anti-diabetic and lipid-lowering medications will be documented.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Alberta
Edmonton, Alberta, T6G 2P5
Caroline Richard, PhD, RD
About this study
Official title: A Preliminary Human Study on Bioavailability and Efficacy of Bioactive Peptide IRW in Egg White Hydrolysate
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).
Read the 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 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.
- Being tested
- Egg White Powder
- Keywords
- high blood pressure, high blood sugar, overweight, obesity
- Medical subject headings
- Hyperglycemia, Hypertension, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Egg White PowderDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Egg white powder (20g) | Placebo comparator | 20 g of egg white powder from the market; negative control; only individuals at risk of diabetes/having type 2 diabetes. Receives: Dietary Supplement: Egg White Powder |
| Egg white hydrolysate Thermoase (5 g) (powder) | Experimental | 5 g; dose based on human equivalent dose calculation; only individuals at risk of diabetes/having type 2 diabetes Receives: Dietary Supplement: Egg White Powder |
| Egg white hydrolysate Thermoase (20 g) (powder) | Experimental | 20 g; dose based on energy percentage used in animal experiment; both healthy control group and at risk of diabetes/having type 2 diabetes Receives: Dietary Supplement: Egg White Powder |
| Egg white hydrolysate Thermoase + Pepsin (20 g) liberating IRW (powder) | Active comparator | 20 g; positive control, only individuals at risk of diabetes/having type 2 diabetes Receives: Dietary Supplement: Egg White Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Peptide concentration (IRW) overtime
iAUC for the plasma peptide concentration (IRW) after the test treatments compared to negative control smoothie
Measured: 5, 10, 20, 30, 60, 90, 120, and 180 minutes after consumption of the smoothie
Secondary outcomes (3)
Plasma glucose over time
iAUC for plasma glucose (up to T= 180 minutes)
Measured: 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)
Measured: 30, 60, 90, 120, and 180 minutes after consumption of the smoothie
Blood pressure over time
Acute effect on blood pressure during the intervention
Measured: 60, 120, and 180 minutes after consumption of the smoothie
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start25 Feb 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Blood SugarStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double-blind randomized cross-over study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianping Wu, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06555393
- Sponsor's protocol ID
- Pro00125956
- Status last verified
- Oct 2026
- First submitted
- 12 Aug 2024
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Human Study on Bioavailability and Efficacy of Bioactive Peptide IRW in Egg White Hydrolysate
- ClinicalTrials.gov ID
- NCT06555393
- Acronym / sponsor ID
- Pro00125956
- Keywords
- high blood pressure, high blood sugar, overweight, obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 25 Feb 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 15 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Double-blind randomized cross-over study.
| Arm | Type | Receives |
|---|---|---|
| Egg white powder (20g) | Placebo comparator | Dietary Supplement: Egg White Powder20 g of egg white powder from the market; negative control; only individuals at risk of diabetes/having type 2 diabetes. |
| Egg white hydrolysate Thermoase (5 g) (powder) | Experimental | Dietary Supplement: Egg White Powder5 g; dose based on human equivalent dose calculation; only individuals at risk of diabetes/having type 2 diabetes |
| Egg white hydrolysate Thermoase (20 g) (powder) | Experimental | Dietary Supplement: Egg White Powder20 g; dose based on energy percentage used in animal experiment; both healthy control group and at risk of diabetes/having type 2 diabetes |
| Egg white hydrolysate Thermoase + Pepsin (20 g) liberating IRW (powder) | Active comparator | Dietary Supplement: Egg White Powder20 g; positive control, only individuals at risk of diabetes/having type 2 diabetes |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Men and women aged between 18 and 70 years living in Edmonton (or Edmonton area/driving distance).
- Normal weight (BMI below 25 kg/m2 or Asian population below 23 kg/m2 )
- Waist circumference below the following ethnic specific cut offs: Canada / USA: <102 cm men and <88 cm women; Europids, Middle-Eastern, Sub-Saharan African, and Mediterranean: <94 cm men and <80 cm women; Asians, Japanese, South and Central Americans: <90 cm men and <80 cm women
- Fasting glucose <5.6 mmol/L
- HbA1c <5.6 %
Key exclusion criteria (7 listed)
- Individuals with a previous history of CVD, renal disorder, monogenic dyslipidemia, with endocrine disorders other than T2D
- Individuals taking chronic anti-inflammatory drugs (including aspirin, antihistamines, and omega-3 supplements)
- Pregnant/lactating women
- Individuals aged above 70 years
- Smokers (current smokers: daily/occasional and those who have smoked more than 100 cigarettes in their life)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Egg White PowderParticipants 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. | Dietary supplement | Egg white hydrolysate Thermoase (20 g) (powder), Egg white hydrolysate Thermoase (5 g) (powder), Egg white hydrolysate Thermoase + Pepsin (20 g) liberating IRW (powder), Egg white powder (20g) |
Primary outcome
Plasma Peptide concentration (IRW) overtime
Time frame: 5, 10, 20, 30, 60, 90, 120, and 180 minutes after consumption of the smoothie
iAUC for the plasma peptide concentration (IRW) after the test treatments compared to negative control smoothie
3 secondary outcomes
Plasma glucose over time
Time frame: 30, 60, 90, 120, and 180 minutes after consumption of the smoothie
Plasma Insulin over time
Time frame: 30, 60, 90, 120, and 180 minutes after consumption of the smoothie
Blood pressure over time
Time frame: 60, 120, and 180 minutes after consumption of the smoothie
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jianping Wu, PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Egg White Powder in people with High Blood Sugar and High Blood Pressure, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paulina Blanco Cervantes, MSc (7804929506, blancoce@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Peptide concentration (IRW) overtime (time frame: 5, 10, 20, 30, 60, 90, 120, and 180 minutes after consumption of the smoothie). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.