Egg Protein Hydrolysate and Vascular Function

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01559896
• Other study ID #: NL36690.068.11
• Status: Completed
• Phase: N/A
• First received: March 19, 2012
• Last updated: August 4, 2014
• Start date: September 2011
• Est. completion date: November 2013

Study information

• Verified date: August 2014
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Arterial Stiffness
• Diabetes Mellitus, Type 2
• Dietary Modification
• Glucose Intolerance
• Impaired Glucose Tolerance
• Type 2 Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
Netherlands	PreCare Trial & Recruitment	Beek	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No