Actively Recruiting

Phase 1
Age: 18Years - 70Years
All Genders
Healthy Volunteers
NCT06555393

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

Led by University of Alberta · Updated on 2026-03-13

28

Participants Needed

1

Research Sites

31 weeks

Total Duration

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AI-Summary

What this Trial 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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and women aged between 18 and 70 years living in Edmonton or nearby areas
  • Healthy control group: normal weight (BMI below 25 kg/m2 or below 23 kg/m2 for Asian participants)
  • Healthy control group: waist circumference below ethnic-specific cutoffs (Canada/USA: <102 cm men, <88 cm women; Europids, Middle-Eastern, Sub-Saharan African, Mediterranean: <94 cm men, <80 cm women; Asians, Japanese, South and Central Americans: <90 cm men, <80 cm women)
  • Healthy control group: fasting glucose below 5.6 mmol/L
  • Healthy control group: HbA1c below 5.6%
  • Healthy control group: blood pressure below 130/85 mmHg
  • Healthy control group: triglycerides below 1.7 mmol/L
  • Healthy control group: HDL-Cholesterol above 1.03 mmol/L for men and above 1.29 mmol/L for women
  • Healthy control group: stable body weight within 3% fluctuation for at least 6 months
  • Healthy control group: never smoked, smoked fewer than 100 cigarettes in life, or quit smoking at least one year ago
  • Individuals at risk of diabetes or with type 2 diabetes: overweight or obese (BMI above 25 kg/m2 or above 23 kg/m2 for Asian participants)
  • Individuals at risk of diabetes or with type 2 diabetes: waist circumference at or above ethnic-specific cutoffs (Canada/USA: ≥102 cm men, ≥88 cm women; Europids, Middle-Eastern, Sub-Saharan African, Mediterranean: ≥94 cm men, ≥80 cm women; Asians, Japanese, South and Central Americans: ≥90 cm men, ≥80 cm women)
  • Individuals at risk of diabetes or with type 2 diabetes: fasting glucose at or above 6.0 mmol/L
  • Individuals at risk of diabetes or with type 2 diabetes: HbA1c at or above 6.0%
  • Individuals at risk of diabetes or with type 2 diabetes: stable body weight within 3% fluctuation for at least 6 months
  • Individuals at risk of diabetes or with type 2 diabetes: never smoked, smoked fewer than 100 cigarettes in life, or quit smoking at least one year ago
Not Eligible

You will not qualify if you...

  • History of cardiovascular disease, kidney disorders, monogenic dyslipidemia, or endocrine disorders other than type 2 diabetes
  • Taking chronic anti-inflammatory drugs including aspirin, antihistamines, or omega-3 supplements
  • Pregnant or breastfeeding women
  • Aged over 70 years
  • Current smokers or those who have smoked more than 100 cigarettes in life
  • Specific nutritional restrictions such as vegetarianism excluding eggs, vegan diet, or egg allergy
  • Poorly controlled diabetes with HbA1c above 12.0% or taking insulin
  • Use of other anti-diabetic or lipid-lowering medications will be documented but not excluded

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Alberta

Edmonton, Alberta, Canada, T6G 2P5

Actively Recruiting

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Research Team

P

Paulina Blanco Cervantes, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

4

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