Cardiovascular DiseasePhase 1NCT01329965
Safety and Feasibility of an Endotoxemia Model
A Phase 1 study testing LPS (reference endotoxin, E. coli O113:H10:K:neg, manufactured under GMP) in people with Cardiovascular Disease and Inflammation, run by Penn State University at 1 site in United States.
Trial summary
The purpose of this study is to establish the safety and feasibility of low dose LPS administration to a small subset of humans in preparation for a larger USDA funded study examining what is the lowest effective dose of EPA + DHA (300, 600, 900 and 1,800 mg/day delivered as fish oil supplements) that significantly… Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease, Inflammation
- What is being tested?
- LPS (reference endotoxin, E. coli O113:H10:K:neg, manufactured under GMP)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Sep 2011
- Phase
- Phase 1
- 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 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and non-pregnant/lactating women between the ages of 20 and 35 years old
- BMI > 19.9 and < 30.0
- Able to give written informed consent and willing to comply with all study- related procedures
Who cannot join
- Previous history of heart disease or diabetes
- Renal Insufficiency
- Chronic anti-inflammatory use
- Systolic blood pressure < 90
- Individuals currently using tobacco products or have done so in the previous 30 days
- Individuals taking Omega-3 fatty acid supplements or their usual intake of fish is greater than 3-4 servings per month
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State University
University Park, Pennsylvania, 16802
About this study
Official title: Safety and Feasibility of an Endotoxemia Model: Pilot Study
The purpose of this study is to establish the safety and feasibility of low dose LPS administration to a small subset of humans in preparation for a larger USDA funded study examining what is the lowest effective dose of EPA + DHA (300, 600, 900 and 1,800 mg/day delivered as fish oil supplements) that significantly attenuates the inflammatory response the investigators wish to examine the effects of an endotoxemia model for inducing inflammation. Based on previous research, low dose LPS administration affects metabolism in humans with only minimal clinical effects (such as "flu" like illness). Therefore, each of the six subjects included in this small pilot study will receive a low dose of LPS and placebo in order to learn more about the metabolic changes that occur during administration and inflammation. The investigators hypothesis that LPS administration will elicit only minimal clinical effects (such as "flu" like illness) when compared to placebo (saline--water with the same amount of salt as in your blood).
- Conditions
- Cardiovascular Disease, Inflammation
- Being tested
- LPS (reference endotoxin, E. coli O113:H10:K:neg, manufactured under GMP)
- Keywords
- Cardiovascular disease, Inflammation, LPS, Endotoxin
- Medical subject headings
- Cardiovascular Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LPS (reference endotoxin, E. coli O113:H10:K:neg, manufactured under GMP)Drug
LPS or placebo (saline-salt water) will be injected (at approximately 7:30 am) in this catheter by a trained GCRC staff member involved with this study. Participants will not be told if they have received the drug or placebo. The LPS is a sterile solution of protein-free endotoxin which will be injected at a dose of 0.6 ng/kg body weight. Blood samples will be collected from a venous catheter for the first 12 hours and by venipuncture thereafter. Subjects will be continuously monitored by trained nursing staff for blood pressure (q 15 minutes) and body temperature (q 30 minutes), and the study will have physician oversight.
| Study group | Role | What they receive |
|---|---|---|
| LPS | Experimental | LPS will be injected at a dose of 0.6 ng/kg body weight through a catheter by a trained GCRC staff member involved with this study. Receives: Drug: LPS (reference endotoxin, E. coli O113:H10:K:neg, manufactured under GMP) |
| Saline | Placebo comparator | A saline solution will be injected through a catheter by a trained GCRC staff member involved with this study. Receives: Drug: LPS (reference endotoxin, E. coli O113:H10:K:neg, manufactured under GMP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Inflammatory Markers
Measured: Baseline (before LPS administration), 1, 2, 3, 4, 6, 12, 24 hrs post LPS administration; 2, 3 and 5 days post LPS administration
Secondary outcomes (1)
Change in Lipid Mediators
Measured: 1, 2, 3 and 5 days post LPS administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionAug 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Responsible party
- Sponsor
- Investigators
- Penny M Kris-Etherton, PhD, RD, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01329965
- Sponsor's protocol ID
- PKE LPSpilot
- Status last verified
- Aug 2023
- First submitted
- 1 Apr 2011
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of an Endotoxemia Model: Pilot Study
- ClinicalTrials.gov ID
- NCT01329965
- Acronym / sponsor ID
- PKE LPSpilot
- Conditions
- Cardiovascular Disease, Inflammation
- Keywords
- Cardiovascular disease, Inflammation, LPS, Endotoxin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Study start
- Apr 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 6 Apr 2011 (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 purpose of this study is to establish the safety and feasibility of low dose LPS administration to a small subset of humans in preparation for a larger USDA funded study examining what is the lowest effective dose of EPA + DHA (300, 600, 900 and 1,800 mg/day delivered as fish oil supplements) that significantly attenuates the inflammatory response the investigators wish to examine the effects of an endotoxemia model for inducing inflammation. Based on previous research, low dose LPS administration affects metabolism in humans with only minimal clinical effects (such as "flu" like illness). Therefore, each of the six subjects included in this small pilot study will receive a low dose of LPS and placebo in order to learn more about the metabolic changes that occur during administration and inflammation. The investigators hypothesis that LPS administration will elicit only minimal clinical effects (such as "flu" like illness) when compared to placebo (saline--water with the same amount of salt as in your blood).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LPS | Experimental | Drug: LPS (reference endotoxin, E. coli O113:H10:K:neg, manufactured under GMP)LPS will be injected at a dose of 0.6 ng/kg body weight through a catheter by a trained GCRC staff member involved with this study. |
| Saline | Placebo comparator | Drug: LPS (reference endotoxin, E. coli O113:H10:K:neg, manufactured under GMP)A saline solution will be injected through a catheter by a trained GCRC staff member involved with this study. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy men and non-pregnant/lactating women between the ages of 20 and 35 years old
- BMI > 19.9 and < 30.0
- Able to give written informed consent and willing to comply with all study- related procedures
Key exclusion criteria (6 listed)
- Previous history of heart disease or diabetes
- Renal Insufficiency
- Chronic anti-inflammatory use
- Systolic blood pressure < 90
- Individuals currently using tobacco products or have done so in the previous 30 days
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 |
|---|---|---|
| LPS (reference endotoxin, E. coli O113:H10:K:neg, manufactured under GMP)LPS or placebo (saline-salt water) will be injected (at approximately 7:30 am) in this catheter by a trained GCRC staff member involved with this study. Participants will not be told if they have received the drug or placebo. The LPS is a sterile solution of protein-free endotoxin which will be injected at a dose of 0.6 ng/kg body weight. Blood samples will be collected from a venous catheter for the first 12 hours and by venipuncture thereafter. Subjects will be continuously monitored by trained nursing staff for blood pressure (q 15 minutes) and body temperature (q 30 minutes), and the study will have physician oversight. | Drug | LPS, Saline |
Primary outcome
Change in Inflammatory Markers
Time frame: Baseline (before LPS administration), 1, 2, 3, 4, 6, 12, 24 hrs post LPS administration; 2, 3 and 5 days post LPS administration
1 secondary outcome
Change in Lipid Mediators
Time frame: 1, 2, 3 and 5 days post LPS administration
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 21 Aug 2023.
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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.
Penny M Kris-Etherton, PhD, RD principal investigator
Penn State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LPS (reference endotoxin, E. coli O113:H10:K:neg, manufactured under GMP) in people with Cardiovascular Disease and Inflammation, run by Penn State 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 3 inclusion and 6 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 21 Aug 2023. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in Inflammatory Markers (time frame: Baseline (before LPS administration), 1, 2, 3, 4, 6, 12, 24 hrs post LPS administration; 2, 3 and 5 days post LPS administration). 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 21 Aug 2023.