Egg-derived peptide IRW tested for blood sugar, blood pressure, and weight.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1 pilot uses a randomized, crossover design in adults with or at high risk for type 2 diabetes who will each attend four single-day treatments separated by at least one week, consuming a standardized breakfast with a smoothie containing different protein powders (including egg white hydrolysate with IRW and controls). Healthy control participants will undergo a single treatment day. The study measures acute effects on blood glucose, blood pressure, and other cardiometabolic markers and will examine IRW bioavailability compared with non-hydrolyzed egg white. IRW is a tripeptide derived from ovotransferrin that has shown ACE2-activating and cardiometabolic benefits in preclinical work, and this study aims to translate those findings into a human feasibility context.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Alberta
  Edmonton, Alberta, Canada Recruiting

Study contacts

• Principal investigator: Jianping Wu, PhD — University of Alberta
• Study coordinator: Paulina Blanco Cervantes, MSc
• Email: blancoce@ualberta.ca
• Phone: 7804929506

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.