Recruiting
Phase 1

IRW

Sponsor:

University of Alberta

Code:

NCT06555393

Conditions

High Blood Sugar

High Blood Pressure

Overweight and Obesity

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

Egg White Powder

Study Details

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).

Conditions

High Blood Sugar

High Blood Pressure

Overweight and Obesity

Study ID

NCT06555393

Start date

Feb 25, 2026

Status verified date

Mar, 2026

Completion date

Oct, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Inclusion Criteria:

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 %
  • 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)

Exclusion Criteria:

  • 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.

Study Design

Enrollment

28 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Egg white powder (20g)

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

experimental: Egg white hydrolysate Thermoase (5 g) (powder)

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

experimental: Egg white hydrolysate Thermoase (20 g) (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

active comparator: Egg white hydrolysate Thermoase + Pepsin (20 g) liberating IRW (powder)

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

Interventions

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.

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 ]

Central Contacts and Locations

Central contacts

Paulina Blanco Cervantes, MSc

7804929506blancoce@ualberta.ca

Locations

University of Alberta

Recruiting

Edmonton, Alberta, Canada, T6G 2P5

More Information

Sponsor

University of Alberta

Last update posted

Mar 13, 2026

Last verified

Mar, 2026

Keywords

  • high blood pressure
  • high blood sugar
  • overweight
  • obesity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alberta on 2026-03-13.