Back to resultsEgg Protein Hydrolysate and Vascular Function
Primary Purpose
Arterial Stiffness, Dietary Modification, Impaired Glucose Tolerance
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
protein hydrolysate capsules and placebo capsules
Sponsored by
About this trial
This is an interventional prevention trial for Arterial Stiffness focused on measuring egg protein hydrolysate
Eligibility 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
Sites / Locations
- PreCare Trial & Recruitment
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
intervention and placebo
Arm Description
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.
Outcomes
Primary Outcome Measures
The change (baseline vs 2 hours, and baseline vs 2 days) in arterial stiffness measured as carotid-femoral pulse wave velocity
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
Full Information
NCT ID
NCT01559896
First Posted
March 19, 2012
Last Updated
August 4, 2014
Sponsor
Maastricht University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01559896
Brief Title
Egg Protein Hydrolysate and Vascular Function
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arterial Stiffness, Dietary Modification, Impaired Glucose Tolerance, Type 2 Diabetes Mellitus
Keywords
egg protein hydrolysate
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention and placebo
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
protein hydrolysate capsules and placebo capsules
Intervention Description
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 Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jogchum Plat, Dr.
Organizational Affiliation
Maastricht University
Official's Role
Principal Investigator
Facility Information:
Facility Name
PreCare Trial & Recruitment
City
Beek
State/Province
Limburg
ZIP/Postal Code
6191 JW
Country
Netherlands
12. IPD Sharing Statement
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Egg Protein Hydrolysate and Vascular Function
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