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

28 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

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.

What data supports the effectiveness of the treatment IRW from Egg White Hydrolysate for high blood sugar and high blood pressure?

Research shows that egg white hydrolysate can lower blood pressure in rats with high blood pressure and improve their blood lipid profile, which includes fats in the blood. This suggests it might help manage high blood pressure and related heart health issues. ^{1 2 3 4 5}

Is egg white powder safe for humans?

Research suggests that egg white hydrolysate, a form of egg white powder, is generally safe and does not cause allergic reactions in humans, as confirmed by a human mast cell activation test. ^{2 3 4 6 7}

How is the egg white hydrolysate treatment different from other treatments for high blood pressure and high blood sugar?

This treatment uses a special protein from egg whites that is broken down into smaller pieces, which can help lower blood pressure by blocking a specific enzyme (angiotensin converting enzyme) that usually raises it. Unlike some medications, it is derived from a natural food source and has shown promising results in animal studies without causing allergic reactions. ^{1 2 3 4 8}

Research Team

Jianping Wu, PhD

Principal Investigator

University of Alberta

Eligibility Criteria

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

Healthy control group: Triglycerides below 1.7 mmol/L

Individuals at risk of diabetes/having type 2 diabetes: Waist circumference at or above specific ethnic cut-offs

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

Exclusion Criteria

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

I regularly take anti-inflammatory drugs, such as aspirin, antihistamines, or omega-3 supplements.

Pregnant/lactating women

Timeline

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Beneficial effects of simulated gastro-intestinal digests of fried egg and its fractions on blood pressure, plasma lipids and oxidative stress in spontaneously hypertensive rats. [2019]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

Enzymatic Hydrolysis of Egg White Protein Exerts a Hypotensive Effect in Spontaneously Hypertensive Rats. [2020]

3. Germany pubmed.ncbi.nlm.nih.gov

Effect of an egg ovalbumin-derived protein hydrolysate on blood pressure and cardiovascular risk in adults with a mildly elevated blood pressure: a randomized placebo-controlled crossover trial. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Short-term effect of egg-white hydrolysate products on the arterial blood pressure of hypertensive rats. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Effect of the long-term intake of an egg white hydrolysate on the oxidative status and blood lipid profile of spontaneously hypertensive rats. [2015]

6. Germany pubmed.ncbi.nlm.nih.gov

Egg White-Derived Antihypertensive Peptide IRW (Ile-Arg-Trp) Reduces Blood Pressure in Spontaneously Hypertensive Rats via the ACE2/Ang (1-7)/Mas Receptor Axis. [2021]

7. Japan pubmed.ncbi.nlm.nih.gov

Egg White Hydrolysate Can Be a Low-Allergenic Food Material to Suppress Ectopic Fat Accumulation in Rats Fed an Equicaloric Diet. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Long-term intake of egg white hydrolysate attenuates the development of hypertension in spontaneously hypertensive rats. [2006]