Egg Protein Hydrolysate and Vascular Function

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01559896
First received: March 19, 2012
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Arterial Stiffness
Dietary Modification
Impaired Glucose Tolerance
Type 2 Diabetes Mellitus
Dietary Supplement: protein hydrolysate capsules and placebo capsules

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

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • The change (baseline vs 2 hours, and baseline vs 2 days) in arterial stiffness measured as carotid-femoral pulse wave velocity [ Time Frame: baseline vs 2 hours, baseline vs 2 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: baseline vs 2 hours, and baseline vs 2 days ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: September 2011
Study Completion Date: November 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01559896

Locations
Netherlands
PreCare Trial & Recruitment
Beek, Limburg, Netherlands, 6191 JW
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Jogchum Plat, Dr. Maastricht University
  More Information

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01559896     History of Changes
Other Study ID Numbers: NL36690.068.11
Study First Received: March 19, 2012
Last Updated: August 4, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
egg protein hydrolysate

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia

ClinicalTrials.gov processed this record on October 01, 2014