Metabolic SyndromePEANCT01215370
Pea Protein and Postprandial Response (PEA)
A study testing High-fat shake with Pea protein, High-fat shake with Pea protein hydrolysate and High-fat shake with Gluten protein in people with Metabolic Syndrome, run by Wageningen University at 1 site in Netherlands.
Trial summary
The main objective is to investigate the postprandial effect of arginine-rich protein (i.e. pea-protein) on metabolic control, inflammation and endothelial function after a high-fat meal in subjects with characteristics of the metabolic syndrome. Read more about this study
- Who is it for?
- Ages 45 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- High-fat shake with Pea protein, High-fat shake with Pea protein hydrolysate and High-fat shake with Gluten protein
- How many people
- 18 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2010to Jan 2011
- 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 45 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male gender
- central obesity: waist circumference ≥94 cm
- plus any one of the following four factors:
- raised triglyceride level: ≥1.7 mmol/L;
- reduced high-density lipoprotein (HDL) cholesterol: <1.03 mmol/L
- raised blood pressure: systolic blood pressure ≥130 mmHg or diastolic BP ≥85 mmHg or use of blood pressure lowering medication
Show all 11Show fewer
- raised fasting plasma glucose ≥ 5.6 mmol/L
- Additional inclusion criteria:
- age 45-70 years
- body weight should be stable for 3 months
- stable exercise habits during the last 6 months, and not participating in any vigorous exercise program
Who cannot join
- tobacco smoking
- (undiagnosed) diabetes - but not impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT) as evaluated by an oral glucose tolerance test at screening
- active hearth disease, i.e. history of myocardial infarction or angina pectoris
- following, or have recently followed a (weight-loss) diet
- drug uses knowing to interfere with the objectives of the study
- oral corticosteroids, lipid-lowering drugs (statins)
Show all 13Show fewer
- allergic to cow milk / dairy products or gluten
- vegetarians
- received inoculations within 2 months of starting or planned to during the study
- donated or intended to donate blood 2 months before till two months after the study
- abuse of drugs and/or alcohol
- participation in another biomedical study within 1 month before the first screening visit
- not agreeable to be informed about possible distorted blood values which could be found by screening
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Wageningen University, Division of Human Nutrition
Wageningen, Gelderland
About this study
Official title: Effect of Arginine-rich Dietary Protein on Postprandial Metabolism, Inflammation and Endothelial Function
The main objective is to investigate the postprandial effect of arginine-rich protein (i.e. pea-protein) on metabolic control, inflammation and endothelial function after a high-fat meal in subjects with characteristics of the metabolic syndrome.
Read the detailed description
Arginine is potential interesting considering the metabolic syndrome. Studies so far indicated both long-term effects, as well as acute - postprandial - actions; especially when metabolism is already challenged, e.g. in diabetic patients or after a high-fat meal. If arginine-rich proteins are equally effective is not known. Therefore we are interested in the effect of (arginine rich) protein on postprandial (dys)metabolism, inflammation and endothelial function, within 6 hours after a meal.
- Conditions
- Metabolic Syndrome
- Being tested
- High-fat shake with Pea protein, High-fat shake with Pea protein hydrolysate, High-fat shake - Control, High-fat shake with Gluten protein, High-fat shake with Gluten protein hydrolysate
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-fat shake with Pea proteinOther
Also called Experimental
Shake containing 95 gram of fat, additive 30 gram pea protein
High-fat shake with Pea protein hydrolysateOther
Also called Experimental
Shake containing 95 gram of fat, additive 30 gram gluten protein hydrolysate
High-fat shake - ControlOther
Also called Control
Shake containing 95 gram of fat, no protein additive
High-fat shake with Gluten proteinOther
Also called Experimental
Shake containing 95 gram of fat, additive 30 gram gluten protein.
High-fat shake with Gluten protein hydrolysateOther
Also called Experimental
Shake containing 95 gram of fat, additive 30 gram gluten gluten hydrolysate
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial metabolic, inflammatory and endothelial response
Metabolic: Plasma glucose, insulin and triglyceride levels (T= 0,1,2,3,4,5 and 6 hrs)
Inflammatory: C-reactive protein (CRP), Plasminogen activator inhibitor-1 (PAI-1), Tumor necrosis factor-alpha (TNF-a), Interleukin-6 (IL-6), Inter-Cellular Adhesion Molecule-1 (ICAM-1) and Monocyte chemotactic protein-1 (MCP-1) (T=0, 2, 4 and 6 hrs).
Endothelial function: Macro vascular regional arterial stiffness by Pulse Wave Analysis (PWA) (T=0, 3 and 6 hrs).
Measured: up to 6 hours
Secondary outcomes (1)
Satiety markers and Oxidative stress
Satiety: Glucagon-like peptide-1 (GLP-1) (T=0,2,4 and 6 hrs).
Oxidative stress: Peripheral blood mononuclear cells (PBMC) (T=0,3 and 6 hrs).
Measured: up to 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Investigators
- Marco Mensink, Dr, Study chair, Department Human Nutrition, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01215370
- Other IDs
- NL3207808110
- Acronym
- PEA
- Status last verified
- Sep 2011
- First submitted
- 30 Sep 2010
- Last updated
- 7 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Arginine-rich Dietary Protein on Postprandial Metabolism, Inflammation and Endothelial Function
- ClinicalTrials.gov ID
- NCT01215370
- Acronym / sponsor ID
- PEA
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 6 Oct 2010 (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 main objective is to investigate the postprandial effect of arginine-rich protein (i.e. pea-protein) on metabolic control, inflammation and endothelial function after a high-fat meal in subjects with characteristics of the metabolic syndrome.
Detailed description
Arginine is potential interesting considering the metabolic syndrome. Studies so far indicated both long-term effects, as well as acute - postprandial - actions; especially when metabolism is already challenged, e.g. in diabetic patients or after a high-fat meal. If arginine-rich proteins are equally effective is not known. Therefore we are interested in the effect of (arginine rich) protein on postprandial (dys)metabolism, inflammation and endothelial function, within 6 hours after a meal.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- male gender
- central obesity: waist circumference ≥94 cm
- raised triglyceride level: ≥1.7 mmol/L;
- reduced high-density lipoprotein (HDL) cholesterol: <1.03 mmol/L
- raised blood pressure: systolic blood pressure ≥130 mmHg or diastolic BP ≥85 mmHg or use of blood pressure lowering medication
Key exclusion criteria (13 listed)
- tobacco smoking
- (undiagnosed) diabetes - but not impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT) as evaluated by an oral glucose tolerance test at screening
- active hearth disease, i.e. history of myocardial infarction or angina pectoris
- following, or have recently followed a (weight-loss) diet
- drug uses knowing to interfere with the objectives of the study
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 |
|---|---|---|
| High-fat shake with Pea proteinAlso: ExperimentalShake containing 95 gram of fat, additive 30 gram pea protein | Other | – |
| High-fat shake with Pea protein hydrolysateAlso: ExperimentalShake containing 95 gram of fat, additive 30 gram gluten protein hydrolysate | Other | – |
| High-fat shake - ControlAlso: ControlShake containing 95 gram of fat, no protein additive | Other | – |
| High-fat shake with Gluten proteinAlso: ExperimentalShake containing 95 gram of fat, additive 30 gram gluten protein. | Other | – |
| High-fat shake with Gluten protein hydrolysateAlso: ExperimentalShake containing 95 gram of fat, additive 30 gram gluten gluten hydrolysate | Other | – |
Primary outcome
Postprandial metabolic, inflammatory and endothelial response
Time frame: up to 6 hours
Metabolic: Plasma glucose, insulin and triglyceride levels (T= 0,1,2,3,4,5 and 6 hrs) Inflammatory: C-reactive protein (CRP), Plasminogen activator inhibitor-1 (PAI-1), Tumor necrosis factor-alpha (TNF-a), Interleukin-6 (IL-6), Inter-Cellular Adhesion Molecule-1 (ICAM-1) and Monocyte chemotactic protein-1 (MCP-1) (T=0, 2, 4 and 6 hrs). Endothelial function: Macro vascular regional arterial stiffness by Pulse Wave Analysis (PWA) (T=0, 3 and 6 hrs).
1 secondary outcome
Satiety markers and Oxidative stress
Time frame: up to 6 hours
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 7 Sep 2011.
Related trials for Metabolic Syndrome
Recruiting
Effects of Pitavastatin or Combination of Pitavastatin and Ezetimibe on Glucose Metabolism Compared to AtoRvastatin in atheroscLerotic Cardiovascular Disease Patients With Metabolic Syndrome: The EZ-PEARL Randomized Trial
Dyslipidemias, Atherosclerotic Cardiovascular Disease
Not yet recruiting
SWitching to Appropriate Prescription in Cardiovascular-Kidney-Metabolic Syndrome
Cardiovascular-kidney-metabolic Syndrome, Diabete Type 2
RecruitingObservational study
Long-Term Follow-Up of Survivors of Pediatric Cushing Disease
Cushing Disease
Recruiting
FITting Non-invasive Tests in Lynch Syndrome Surveillance
Colorectal Cancer
Not yet recruitingEarly Phase 1
Human Cerebrovascular Blood Flow and Sex Differences in Metabolic Syndrome
Metabolic Syndrome
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.
Marco Mensink, Dr study chair
Department Human Nutrition, Wageningen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-fat shake with Pea protein, High-fat shake with Pea protein hydrolysate and High-fat shake with Gluten protein in people with Metabolic Syndrome, run by Wageningen University 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 11 inclusion and 13 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 7 Sep 2011. 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?
Postprandial metabolic, inflammatory and endothelial response (time frame: up to 6 hours). 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 7 Sep 2011.