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Official title Understanding the Health Effect of a Bioactive Peptide From Egg: A Pilot Study
ClinicalTrials.gov ID: NCT06555393
What this study is testing
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70. Healthy volunteers may be eligible.
You may be able to join 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...
- Fasting glucose \<5.6 mmol/L
You likely can't join 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
See the full eligibility 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...
- 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...
- 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)
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Edmonton, Alberta, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Edmonton, Alberta, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.