Recruiting

Bioactive Peptide IRW in Egg White Hydrolysate for Metabolic Syndrome Mitigation

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What is being tested

Egg White Powder

Dietary Supplement
Who is being recruted

Body Weight+11

+ Cardiovascular Diseases

+ Hyperglycemia

From 18 to 70 Years
+21 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 1
Interventional
Study Start: February 2026
See protocol details

Summary

Principal SponsorUniversity of Alberta
Study ContactPaulina Blanco Cervantes, MSc
Last updated: March 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 25, 2026

Actual date on which the first participant was enrolled.

This study explores a special protein fragment called IRW, found in egg whites, which might help improve health by activating a key enzyme known as ACE2. ACE2 is important because it helps protect the heart and metabolism and is known as the entry point for some viruses, including the coronavirus. By activating ACE2, IRW could potentially help manage conditions like high blood pressure and type-2 diabetes. This research is important because it aims to turn egg whites into a functional food that could help mitigate metabolic syndrome, offering a new dietary strategy for these conditions. Participants in this trial will consume a product made from egg white hydrolysate, where IRW is expected to be released in the body with the help of digestive enzymes. The study will examine how well IRW is absorbed and its effectiveness in humans. By using whole egg whites as a starting material, the study aims to create an affordable and practical dietary solution. The trial will focus on assessing the bioavailability and health benefits of IRW, providing insights into its potential as a valuable dietary addition.

Official TitleA Preliminary Human Study on Bioavailability and Efficacy of Bioactive Peptide IRW in Egg White Hydrolysate
NCT06555393
Principal SponsorUniversity of Alberta
Study ContactPaulina Blanco Cervantes, MSc
Last updated: March 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

28 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightCardiovascular DiseasesHyperglycemiaHypertensionMetabolic DiseasesNutrition DisordersNutritional and Metabolic DiseasesObesitySigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesOvernutritionGlucose Metabolism DisordersOverweight

Criteria

14 inclusion criteria required to participate
HbA1c \<5.6 %

Fasting glucose ≥ 6.0 mmol/L

HbA1c ≥ 6.0 %

Body weight stable (within 3% fluctuation) for at least 6 months prior to the study

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7 exclusion criteria prevent from participating
Individuals taking chronic anti-inflammatory drugs (including aspirin, antihistamines, and omega-3 supplements)

Pregnant/lactating women

Smokers (current smokers: daily/occasional and those who have smoked more than 100 cigarettes in their life)

Individuals with a previous history of CVD, renal disorder, monogenic dyslipidemia, with endocrine disorders other than T2D

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

25% chance of being blinded to the placebo group

Treatment Groups

Group I

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

Group II

Experimental
5 g; dose based on human equivalent dose calculation; only individuals at risk of diabetes/having type 2 diabetes

Group III

Active Comparator
20 g; positive control, only individuals at risk of diabetes/having type 2 diabetes

Group IV

Placebo
20 g of egg white powder from the market; negative control; only individuals at risk of diabetes/having type 2 diabetes.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

University of Alberta

Edmonton, CanadaOpen University of Alberta in Google Maps
Recruiting
One Study Center