Egg White Powder for High Blood Sugar and High Blood Pressure

Overseen By Paulina Blanco Cervantes, MSc

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Alberta

Must not be taking: Anti-inflammatories, Insulin

Disqualifiers: CVD, Renal disorder, Endocrine disorders, others

Compensation: Varies

Number of Visits: 4

Duration: 4-6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a compound from egg whites, specifically IRW from Egg White Hydrolysate, can help manage high blood sugar and blood pressure. Participants at risk for type 2 diabetes or already diagnosed with it will try different protein powders mixed in a smoothie to observe the effects on their health. Individuals who are overweight and experience high blood sugar may be suitable for this study. The trial will also include a healthy control group for comparison. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the chance to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those taking chronic anti-inflammatory drugs. Other anti-diabetic and lipid-lowering medications will be documented, so you may not need to stop them.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that egg white hydrolysates, such as IRW, are generally safe for people. Studies have found that these egg-based proteins can lower blood pressure and improve blood vessel health. Earlier research reported no major side effects, suggesting the treatment's safety for humans.

As this clinical trial is in its early stages, it primarily focuses on assessing safety and understanding the body's response to the treatment. While strong evidence supports the safety of IRW, this trial continues to gather detailed information on how participants tolerate it. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for high blood sugar and high blood pressure?

Unlike the standard treatments for high blood sugar and high blood pressure, which typically involve medications like metformin or ACE inhibitors, the treatments in this trial utilize egg white hydrolysate, specifically IRW, as a novel approach. IRW is a peptide derived from egg whites that shows potential in reducing blood sugar and blood pressure by inhibiting certain enzymes related to these conditions. Researchers are excited because this approach offers a natural alternative that might have fewer side effects compared to conventional drugs. Plus, using a food-based product could make it more accessible and acceptable for people looking for dietary interventions.

What evidence suggests that this trial's treatments could be effective for managing high blood sugar and high blood pressure?

Research shows that a protein from egg whites, particularly a component called IRW, might help control high blood sugar and blood pressure. Studies have found that these egg proteins can lower blood sugar and improve insulin function in type 2 diabetes. For instance, after seven weeks of treatment, diabetic mice showed lower fasting blood sugar levels. This trial will test different formulations of egg white hydrolysate, including IRW, to evaluate their effects on blood sugar and blood pressure. Additionally, these proteins have demonstrated anti-inflammatory effects and other benefits, which could aid in managing high blood pressure. ^{1 4 6 7 8}

Who Is on the Research Team?

Jianping Wu, PhD

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My waist size is within the healthy range for my ethnicity.

Healthy control group: Triglycerides below 1.7 mmol/L

Healthy control group: HDL-Cholesterol levels within specified ranges

Exclusion Criteria

Smokers (current smokers: daily/occasional and those who have smoked more than 100 cigarettes in their life)

Pregnant/lactating women

Individuals with specific nutritional restrictions will be excluded

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 4 consecutive treatments of 1 day each, separated by a minimum of 1 week, consuming a standardized breakfast with a smoothie containing different protein powders.

4-6 weeks

4 visits (in-person) for at-risk participants, 1 visit (in-person) for healthy controls

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• IRW from Egg White Hydrolysate

Trial Overview 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.

How Is the Trial Designed?

Group I: Egg white hydrolysate Thermoase (5 g) (powder) Experimental Treatment 1 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 Treatment 1 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 Control 1 Intervention

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

Group IV: Egg white powder (20g) Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Citations

1. esmed.org esmed.org/MRA/mra/article/view/6973

A review of the efficacy of egg-derived bioactive peptides ... This review summarizes evidence from preclinical and clinical studies investigating the glucoregulatory effects of egg white hydrolysate and egg ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0924224420305604

Egg-derived peptides and hydrolysates: A new bioactive ... Food-derived bioactive peptides have demonstrated anti-inflammatory, hypocholesterolemic and/or anti-diabetic activities, improving adipose tissue dysfunction, ...

3. clinicaltrial.be clinicaltrial.be/fr/details/446672?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

Understanding the Health Effect of a Bioactive Peptide Fr... Egg white powder without a process of hydrolyzation will not liberate the IRW, therefore, this will be used as a negative control. However, it ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38855929/

Egg white-derived peptides reduced blood glucose in high- ... Our results showed that 7 weeks of EWP treatment reduced the fasting blood glucose in T2DM mice and the inhibition of the liver gluconeogenic pathway was ...

5. mdpi.com mdpi.com/2072-6643/10/5/549

Egg and Soy-Derived Peptides and Hydrolysates This review focuses on the effects of EH and soy hydrolysate (SH) or peptides in improving or preventing type 2 diabetes (T2D) and obesity in vivo or relevant ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8469013/

The Role of Bioactive Peptides in Diabetes and Obesity Attenuate the development of hypertension: systolic blood pressure is increased ... Egg white protein hydrolysate reduces blood pressure, improves vascular ...

7. news-medical.net news-medical.net/news/20250501/Egg-white-proteins-show-promise-in-naturally-lowering-blood-pressure.aspx

Egg white proteins show promise in naturally lowering ... Recent studies have shown that egg white proteins, even after depleting ovotransferrin, can still provide effective antihypertensive peptides.

8. maxapress.com maxapress.com/data/article/fmr/preview/pdf/fmr-0024-0026.pdf

Ovotransferrin-depleted egg white hydrolysate reduces ... Egg white hydrolysate prepared by thermoase (EWH) possesses antihypertensive effects. Our recent study showed that egg white proteins, after ...