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The effect of egg protein hydrolysate on arterial stiffness in overweight or moderately obese subjects with impaired glucose tolerance / diabetes type 2

The effect of egg protein hydrolysate on arterial stiffness in overweight or moderately obese subjects with impaired glucose tolerance / diabetes type 2 - Egg protein hydrolysate and vascular function

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON39274
Enrollment
40
Registered
2011-06-30
Start date
2011-09-15
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

vaatflexibiliteit arterial stiffness

Interventions

The egg protein hydrolysate or placebo (amylum as inert filling material) will be given to the participants in capsules. The subjects will take the hydrolysate or placebo capsules (5 gr/day) on stud

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - No allergy to chicken egg protein - Age between 18 and 70 years - Male and female - Body Mass Index (BMI) between 25-35 kg/m2 - Diagnosed T2DM (use of antidiabetic drugs and/or a diabetic diet is allowed) or impaired glucose tolerance (IGT) defined as blood glucose > 7.0 mmol/L and

Exclusion criteria

Exclusion criteria: - Active cardiovascular disease like congestive heart failure or recent ( 21 units per week) - Pregnant or breastfeeding women - Current smoker - Having donated blood at the blood bank within a period of 8 weeks prior to the start of the study

Design outcomes

Primary

MeasureTime frame
The main study endpoint will be the change (baseline versus 2 hours, and baseline versus 2 days) arterial stiffness measured as carotid-femoral pulse wave velocity after consumption of the egg protein hydrolysate.

Secondary

MeasureTime frame
Secundary study endpoints will be the changes in plasma glucose and insulin concentrations and calculated HOMA-index, incretins, changes in serum lipids, changes in characteristics of the microcirculation as assessed by fundusphotography, changes in non-invasively assessed upper-arm blood pressure and Sphygmocor-derived central aortic systolic blood pressure and heart rate changes after the use of hydrolysate.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)