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Completed

NCT Number: NCT01559896

Egg Protein Hydrolysate and Vascular Function

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.

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Key information

Conditions

Arterial Stiffness Diabetes Mellitus Diabetes Mellitus, Type 2 Dietary Modification Endocrine System Diseases Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Impaired Glucose Tolerance Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes Mellitus

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PreCare Trial & Recruitment

Beek, Limburg, 6191 JW, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

protein hydrolysate capsules and placebo capsules

Dietary Supplement

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 21, 2012
Registry last updated
Aug 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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