Type 2 Diabetes (T2D) Clinical Trials

Find Type 2 Diabetes (T2D) Clinical Trials Near You

A Preliminary Human Study on Bioavailability and Efficacy of Bioactive Peptide IRW in Egg White Hydrolysate

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Phase 1
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: t
View:

⁃ 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)

Locations
Other Locations
Canada
University of Alberta
RECRUITING
Edmonton
Contact Information
Primary
Paulina Blanco Cervantes, MSc
blancoce@ualberta.ca
7804929506
Time Frame
Start Date: 2026-02-25
Estimated Completion Date: 2026-10
Participants
Target number of participants: 28
Treatments
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
Sponsors
Leads: University of Alberta

This content was sourced from clinicaltrials.gov