Understanding the Health Effect of a Bioactive Peptide From Egg: A Pilot Study
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Alberta
About 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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Egg White Powder
Dietary supplementParticipants will consume a standardized breakfast (2 slices of 70 g whole wheat bread, 10 g of butter and 30 g of strawberry jam) followed by a smoothie containing the powder. The Egg White Powder will be incorporated in the standardized smoothie containing water, fruits and chocolate/strawberry syrup totaling 250 Kcal. The total calories of the breakfast will be adapted to the calorie needs of each participant to account for 20-25% of their daily calorie intake. After a 9 h fast, blood will be taken before consumption of the standardized breakfast and smoothie (T= 0) and at 5, 10, 20, 30, 60, 90, 120, and 180 min after consumption of the smoothie. Participants will be given 15-25 minutes to eat their breakfast. Urine samples will be collected from participants before the smoothie consumption (0 h) and at 30 min, 90 min, 150 min, 6 hours, 12 hours, and 24 hours following consumption.
Treatment groups
28 Participants
are divided into 4 treatment groupsGroup A: Egg white powder (20g)Placebo comparator 1 intervention
Group B: Egg white hydrolysate Thermoase (5 g) (powder)Experimental treatment 1 intervention
Group C: Egg white hydrolysate Thermoase (20 g) (powder)Experimental treatment 1 intervention
Group D: Egg white hydrolysate Thermoase + Pepsin (20 g) liberating IRW (powder)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Plasma Peptide concentration (IRW) overtime
iAUC for the plasma peptide concentration (IRW) after the test treatments compared to negative control smoothie
Time frame
5, 10, 20, 30, 60, 90, 120, and 180 minutes after consumption of the smoothieSecondary outcomes
1
Plasma glucose over time
iAUC for plasma glucose (up to T= 180 minutes)
Time frame
30, 60, 90, 120, and 180 minutes after consumption of the smoothie2
Plasma Insulin over time
iAUC for plasma insulin (up to T=180 minutes)
Time frame
30, 60, 90, 120, and 180 minutes after consumption of the smoothie3
Blood pressure over time
Acute effect on blood pressure during the intervention
Time frame
60, 120, and 180 minutes after consumption of the smoothieSponsors and contacts
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Source ClinicalTrials.gov