Arterial StiffnessNCT01559896
Egg Protein Hydrolysate and Vascular Function
A study of Arterial Stiffness and Dietary Modification, run by Maastricht University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Arterial Stiffness, Dietary Modification, Impaired Glucose Tolerance
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2011to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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);
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Arterial Stiffness, Dietary Modification, Impaired Glucose Tolerance, Type 2 Diabetes Mellitus
- Being tested
- protein hydrolysate capsules and placebo capsules
- Keywords
- egg protein hydrolysate
- Medical subject headings
- Glucose Intolerance, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
protein hydrolysate capsules and placebo capsulesDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| intervention and placebo | Experimental | 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. Receives: Dietary Supplement: protein hydrolysate capsules and placebo capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change (baseline vs 2 hours, and baseline vs 2 days) in arterial stiffness measured as carotid-femoral pulse wave velocity
Measured: 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
Measured: baseline vs 2 hours, and baseline vs 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2012 (estimated)
- Study startSep 2011
- Primary completionMay 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial StiffnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jogchum Plat, Dr., Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01559896
- Sponsor's protocol ID
- NL36690.068.11
- Status last verified
- Aug 2014
- First submitted
- 19 Mar 2012
- Last updated
- 5 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01559896
- Acronym / sponsor ID
- NL36690.068.11
- Conditions
- Arterial Stiffness, Dietary Modification, Impaired Glucose Tolerance, Type 2 Diabetes Mellitus
- Keywords
- egg protein hydrolysate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- May 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 21 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention and placebo | Experimental | Dietary Supplement: protein hydrolysate capsules and placebo capsulesOnce 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| protein hydrolysate capsules and placebo capsulesOnce 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 | intervention and placebo |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jogchum Plat, Dr. principal investigator
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Arterial Stiffness and Dietary Modification, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2014.