NCT06555393RecruitingPhase 1
Understanding the Health Effect of a Bioactive Peptide From Egg: A Pilot Study
A Preliminary Human Study on Bioavailability and Efficacy of Bioactive Peptide IRW in Egg White Hydrolysate
Source: ClinicalTrials.gov · Last updated 26 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 28 (estimated)
- First submitted
- 12 Aug 2024
- Start date
- 25 Feb 2026
- Primary completion date
- Jan 2027
- Lead sponsor
- University of Alberta
- Diseases
- Obesity, High blood pressure
- NCT number
- NCT06555393
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 28
- From 25 Feb 2026 to the primary completion date, Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- Individuals with specific nutritional restrictions (e.g. vegetarianism excluding eggs from their diet, vegan or with egg allergy) will be excluded
Lab values
- 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.
Age
- Individuals aged above 70 years
Other
- Pregnant/lactating women
- Smokers (current smokers: daily/occasional and those who have smoked more than 100 cigarettes in their life)
Who the study is looking for
- 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)
Age in the registry: 18 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Alberta Coordinator of this site? Confirm its status | Edmonton | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.