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

NCT06555393 | Recruiting Phase 1 DMC

• 1 other identifier: Pro00125956
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

High Blood Sugar; High Blood Pressure; Overweight and Obesity

Keywords

high blood pressure; high blood sugar; overweight; obesity

Outcome Measures

Primary Outcomes (1)

• Plasma Peptide concentration (IRW) overtime

  iAUC for the plasma peptide concentration (IRW) after the test treatments compared to negative control smoothie

  5, 10, 20, 30, 60, 90, 120, and 180 minutes after consumption of the smoothie

Secondary Outcomes (3)

• Plasma glucose over time

  30, 60, 90, 120, and 180 minutes after consumption of the smoothie

• Plasma Insulin over time

  30, 60, 90, 120, and 180 minutes after consumption of the smoothie

• Blood pressure over time

  60, 120, and 180 minutes after consumption of the smoothie

Study Arms (4)

Egg white powder (20g)

PLACEBO COMPARATOR

20 g of egg white powder from the market; negative control; only individuals at risk of diabetes/having type 2 diabetes.

Dietary Supplement: Egg White Powder

Egg white hydrolysate Thermoase (5 g) (powder)

EXPERIMENTAL

5 g; dose based on human equivalent dose calculation; only individuals at risk of diabetes/having type 2 diabetes

Dietary Supplement: Egg White Powder

Egg white hydrolysate Thermoase (20 g) (powder)

EXPERIMENTAL

20 g; dose based on energy percentage used in animal experiment; both healthy control group and at risk of diabetes/having type 2 diabetes

Dietary Supplement: Egg White Powder

Egg white hydrolysate Thermoase + Pepsin (20 g) liberating IRW (powder)

ACTIVE COMPARATOR

20 g; positive control, only individuals at risk of diabetes/having type 2 diabetes

Dietary Supplement: Egg White Powder

Interventions

Egg White Powder DIETARY_SUPPLEMENT

Participants will consume a standardized breakfast (2 slices of 70 g whole wheat bread, 10 g of butter and 30 g of strawberry jam) followed by a smoothie containing the powder. The Egg White Powder will be incorporated in the standardized smoothie containing water, fruits and chocolate/strawberry syrup totaling 250 Kcal. The total calories of the breakfast will be adapted to the calorie needs of each participant to account for 20-25% of their daily calorie intake. After a 9 h fast, blood will be taken before consumption of the standardized breakfast and smoothie (T= 0) and at 5, 10, 20, 30, 60, 90, 120, and 180 min after consumption of the smoothie. Participants will be given 15-25 minutes to eat their breakfast. Urine samples will be collected from participants before the smoothie consumption (0 h) and at 30 min, 90 min, 150 min, 6 hours, 12 hours, and 24 hours following consumption.

Egg white hydrolysate Thermoase (20 g) (powder); Egg white hydrolysate Thermoase (5 g) (powder); Egg white hydrolysate Thermoase + Pepsin (20 g) liberating IRW (powder); Egg white powder (20g)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify 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.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2P5, Canada

RECRUITING

MeSH Terms

Conditions

Hyperglycemia; Hypertension; Overweight; Obesity

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Vascular Diseases; Cardiovascular Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jianping Wu, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paulina Blanco Cervantes, MSc

CONTACT

7804929506; blancoce@ualberta.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blind randomized cross-over study.

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 15, 2024
• Study Start: February 25, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

CA (1)