Coronary Artery DiseaseNCT00924157
Effect of Ile-Pro-Pro (IPP) on Endothelial Function in Patients With Coronary Artery Disease
A study testing IPP in people with Coronary Artery Disease, run by Boston University at 1 site in United States.
Trial summary
This study will investigate whether the lacto-tripeptide Ile-Pro-Pro (IPP) improves the function of the endothelium in patients with coronary artery disease. The study has a crossover design. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- IPP
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to May 2012
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Coronary artery disease
Who cannot join
- Treatment with an ACE inhibitor or ARB
- Pregnancy
- Other major illness
- Treatment with an investigational drug within 4 weeks
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University Medical Center
Boston, Massachusetts, 02118
About this study
Official title: Effect of a Protein Hydrolysate Rich in Lacto-tripeptide (IPP) on Hyperemic Blood Flow and Flow-mediated Dilation in Patients With Coronary Artery Disease
This study will investigate whether the lacto-tripeptide Ile-Pro-Pro (IPP) improves the function of the endothelium in patients with coronary artery disease. The study has a crossover design. Participants will be treated with a protein hydrolysate rich in IPP for 12 weeks and placebo for 12 weeks with a four-week rest period between treatment periods. The investigators will use ultrasound to test the function of the endothelium in the brachial artery before, after 6 weeks, and after 12 weeks of each treatment. Blood will be collected before and after each treatment. The investigators hypothesize that IPP will improve endothelial function.
- Conditions
- Coronary Artery Disease
- Being tested
- IPP, Placebo
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPPDietary supplement
Protein hydrolysate rich in lacto-tripeptide (IPP) up to 5 to 15 mg/day
PlaceboOther
Matching placebo capsules
What is being measured
The primary outcome is the main question the study is designed to answer.
Brachial Artery Flow-Mediated Dilation and Reactive Hyperemia
Measured: 12 weeks
Secondary outcomes (4)
Carotid-Femoral Pulse Wave Velocity
Measured: 12 weeks
Leg Reactive Hyperemia
Measured: 12 weeks
Digital Pulse Amplitude Tonometry
Measured: 12 weeks
Blood pressure
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2009 (estimated)
- Study startJul 2009
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph A. Vita, Boston University
- Investigators
- Joseph A Vita, MD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00924157
- Sponsor's protocol ID
- H-27820
- Status last verified
- May 2012
- First submitted
- 16 Jun 2009
- Last updated
- 25 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Protein Hydrolysate Rich in Lacto-tripeptide (IPP) on Hyperemic Blood Flow and Flow-mediated Dilation in Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT00924157
- Acronym / sponsor ID
- H-27820
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 18 Jun 2009 (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.
This study will investigate whether the lacto-tripeptide Ile-Pro-Pro (IPP) improves the function of the endothelium in patients with coronary artery disease. The study has a crossover design. Participants will be treated with a protein hydrolysate rich in IPP for 12 weeks and placebo for 12 weeks with a four-week rest period between treatment periods. The investigators will use ultrasound to test the function of the endothelium in the brachial artery before, after 6 weeks, and after 12 weeks of each treatment. Blood will be collected before and after each treatment. The investigators hypothesize that IPP will improve endothelial function.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Coronary artery disease
Key exclusion criteria (4 listed)
- Treatment with an ACE inhibitor or ARB
- Pregnancy
- Other major illness
- Treatment with an investigational drug within 4 weeks
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 |
|---|---|---|
| IPPProtein hydrolysate rich in lacto-tripeptide (IPP) up to 5 to 15 mg/day | Dietary supplement | – |
| PlaceboMatching placebo capsules | Other | – |
Primary outcome
Brachial Artery Flow-Mediated Dilation and Reactive Hyperemia
Time frame: 12 weeks
4 secondary outcomes
Carotid-Femoral Pulse Wave Velocity
Time frame: 12 weeks
Leg Reactive Hyperemia
Time frame: 12 weeks
Digital Pulse Amplitude Tonometry
Time frame: 12 weeks
Blood pressure
Time frame: 12 weeks
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 25 May 2012.
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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.
Joseph A Vita, MD principal investigator
Boston 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 IPP in people with Coronary Artery Disease, run by Boston University at 1 site in United States.
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 1 inclusion and 4 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 25 May 2012. 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 United States. 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?
Brachial Artery Flow-Mediated Dilation and Reactive Hyperemia (time frame: 12 weeks). 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 25 May 2012.