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Bioactive Peptide
Egg White Powder for High Blood Sugar and High Blood Pressure
Phase 1
Waitlist Available
Led By Jianping Wu, PhD
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Individuals at risk of diabetes/having type 2 diabetes: Fasting glucose levels at or above 6.0 mmol/L
Healthy control group: Normal weight (BMI below 25 kg/m2 or Asian population below 23 kg/m2)
Must not have
Individuals aged above 70 years
Individuals with poorly controlled diabetes (HbA1c above 12.0%) or taking exogenous insulin will be excluded. Other anti-diabetic and lipid-lowering medications will be documented
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60, 120, and 180 minutes after consumption of the smoothie
Awards & highlights
Summary
"This trial is investigating the potential benefits of a bioactive peptide called IRW, derived from egg white hydrolysate, for managing high blood sugar and blood pressure. Participants at risk for or with type
Who is the study for?
This trial is for individuals at high risk of type 2 diabetes or those already diagnosed with it. They should be willing to consume a standardized breakfast with a smoothie containing different protein powders on four separate days, each one week apart. Healthy controls will participate in just one treatment.
What is being tested?
The study is testing the health effects of IRW, a bioactive peptide from egg white hydrolysate, on managing high blood sugar and pressure. Participants will receive this ingredient through smoothies during their breakfast to see if there's an acute benefit.
What are the potential side effects?
Since the intervention involves food-derived peptides, side effects might include potential allergic reactions or gastrointestinal discomfort; however, specific side effects are not detailed as this is an initial feasibility study.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My fasting blood sugar level is 6.0 mmol/L or higher.
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I am of normal weight according to BMI standards.
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My fasting blood sugar is below 5.6 mmol/L.
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My blood pressure is below 130/85 mmHg.
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I am overweight or obese according to BMI standards for diabetes risk.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am over 70 years old.
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My diabetes is well-controlled, and I am not on insulin.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30, 60, 90, 120, and 180 minutes after consumption of the smoothie
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30, 60, 90, 120, and 180 minutes after consumption of the smoothie
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Plasma Peptide concentration (IRW) overtime
Secondary study objectives
Blood pressure over time
Plasma Insulin over time
Plasma glucose over time
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Egg white hydrolysate Thermoase (5 g) (powder)Experimental Treatment1 Intervention
5 g; dose based on human equivalent dose calculation; only individuals at risk of diabetes/having type 2 diabetes
Group II: Egg white hydrolysate Thermoase (20 g) (powder)Experimental Treatment1 Intervention
20 g; dose based on energy percentage used in animal experiment; both healthy control group and at risk of diabetes/having type 2 diabetes
Group III: Egg white hydrolysate Thermoase + Pepsin (20 g) liberating IRW (powder)Active Control1 Intervention
20 g; positive control, only individuals at risk of diabetes/having type 2 diabetes
Group IV: Egg white powder (20g)Placebo Group1 Intervention
20 g of egg white powder from the market; negative control; only individuals at risk of diabetes/having type 2 diabetes.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
University of AlbertaLead Sponsor
917 Previous Clinical Trials
430,901 Total Patients Enrolled
20 Trials studying Obesity
11,969 Patients Enrolled for Obesity
Jianping Wu, PhDPrincipal InvestigatorUniversity of Alberta
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