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

Launched by UNIVERSITY OF ALBERTA · Aug 12, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a special protein from egg whites, called IRW, to see if it can help people manage high blood sugar and high blood pressure. The study will involve participants who are at risk of developing type 2 diabetes or who already have it, as well as a healthy control group. Participants will take part in four different one-day sessions where they will eat a standardized breakfast that includes a smoothie with various protein powders, while the healthy group will only have one session.

To be eligible for the trial, participants should be between 18 and 70 years old and live in or around Edmonton. Those in the high-risk group need to be overweight or have obesity, while the healthy control group should have a normal weight. Both groups must meet certain health guidelines, such as having stable blood sugar and blood pressure levels. It’s important to note that individuals with certain health conditions, smokers, or those with specific dietary restrictions will not be included in the study. If you qualify and decide to participate, you’ll be contributing to valuable research that could help improve health outcomes for people with high blood sugar and blood pressure.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 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)
• Exclusion Criteria:
• • 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.