Egg Protein Hydrolysate and Vascular Function

The Effect of Egg Protein Hydrolysate on Arterial Stiffness in Overweight or Moderately Obese Subjects With Impaired Glucose Tolerance or Diabetes Type 2

The incidence of type 2 diabetes mellitus (T2DM) is rapidly growing. Patients with T2DM are at increased risk of developing long term micro- and macrovascular complications. Subjects with impaired glucose tolerance (IGT) show increased blood glucose levels after an oral glucose load. These subjects have a markedly increased risk of later T2DM development.

T2DM development can be prevented or delayed by lifestyle modifications. To support lifestyle changes and reduce the risk of T2DM development, foods containing functional ingredients are being developed. An interesting functional ingredient is protein hydrolysate. An egg protein hydrolysate has been experimentally shown to improve endothelial function, to inhibit plasma angiotensin converting enzyme (ACE) and to reduce blood pressure in rats. Egg protein hydrolysate could thus be a interesting ingredient to treat the cardiovascular dysfunction associated with T2DM. In the present study, the effects of egg protein hydrolysate will be evaluated in subjects with overweight or moderate obesity and IGT or T2DM.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus; Impaired Glucose Tolerance; Dietary Modification; Arterial Stiffness
• Intervention / Treatment: Dietary supplement: protein hydrolysate capsules and placebo capsules

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Beek, Limburg, Netherlands, 6191 JW
      • PreCare Trial & Recruitment

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age between 18 and 70 years;
• male and female;
• Body Mass Index (BMI) between 25-35 kg/m2;
• Diagnosed T2DM (subjects are allowed to use oral antidiabetics and/or to be on a diabetes diet) or impaired glucose tolerance (defined as blood glucose > 7.8 mmol/l and < 11.0 mmol/L, two hours after ingesting 75 gram glucose in 150 ml water)

Exclusion Criteria:

• known allergy to (chicken) egg proteins;
• active cardiovascular diseases like congestive heart failure or recent (< 6 months) event (acute myocardial infarction, cerebral vascular incident);
• severe medical conditions related to the intestine that might interfere with the study such as inflammatory bowel disease and celiac disease;
• the use of insulin;
• the use of medication such as antihypertensives, statins or drugs that change gastric motility or emptying;
• abuse of drugs or alcohol (> 21 units per week);
• pregnant or breast-feeding women;
• current smoker;
• having donated blood at the blood bank within a period of 8 weeks prior to the start of the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: intervention and placebo; Once in the study, 20 subjects will be randomly assigned to a group taking capsules containing 5 gr egg protein hydrolysate per day, and 20 to a group taking placebo capsules. The subjects consume the capsules during three consecutive days (period 1). Following a wash-out period of minimally four weeks, the treatments are crossed-over.

Dietary supplement: protein hydrolysate capsules and placebo capsules; Once in the study, 20 subjects will be randomly assigned to a group taking capsules containing 5 gr egg protein hydrolysate per day, and 20 to a group taking placebo capsules. The subjects consume the capsules during three consecutive days (period 1). Following a wash-out period of minimally four weeks, the treatments are crossed-over.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The change (baseline vs 2 hours, and baseline vs 2 days) in arterial stiffness measured as carotid-femoral pulse wave velocity	baseline vs 2 hours, baseline vs 2 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in glucose and insulin concentrations and calculated HOMA-index, incretins, lipids, characteristics of the microcirculation, and non-invasively assessed upper-arm blood pressure and central aortic systolic blood pressure and heart rate changes	baseline vs 2 hours, and baseline vs 2 days

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Investigators: Principal Investigator: Jogchum Plat, Dr., Maastricht University

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: March 19, 2012
• First Submitted That Met QC Criteria: March 20, 2012
• First Posted (Estimate): March 21, 2012

Study Record Updates

• Last Update Posted (Estimate): August 5, 2014
• Last Update Submitted That Met QC Criteria: August 4, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: egg protein hydrolysate
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hyperglycemia; Diabetes Mellitus, Type 2; Glucose Intolerance
• Other Study ID Numbers: NL36690.068.11