Understanding the Health Effect of a Bioactive Peptide From Egg: A Pilot Study

What this study is about

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).

Who can join (things the study team will check)

✅ You may be able to join if…

• 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)

🚫 You may not be able to join if…

• 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 this trial is running

• University of Alberta, Edmonton, Alberta, Canada

Who to contact

Paulina Blanco Cervantes, MSc · 7804929506 · blancoce@ualberta.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06555393.