Safety and Feasibility of an Endotoxemia Model

NCT01329965 | Completed Phase 1 DMC

• 1 other identifier: PKE LPSpilot
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

Cardiovascular disease; Inflammation; LPS; Endotoxin

Outcome Measures

Primary Outcomes (1)

• Change in Inflammatory Markers

  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

  1, 2, 3 and 5 days post LPS administration

Study Arms (2)

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.

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.

Drug: LPS (reference endotoxin, E. coli O113:H10:K:neg, manufactured under GMP)

Interventions

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.

LPS; Saline

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Penn State University: lead
• United States Department of Agriculture (USDA): collaborator

Study Sites (1)

Penn State University

University Park, Pennsylvania, 16802, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Inflammation

Interventions

Lipopolysaccharides

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycoconjugates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Lipids; Antigens, Bacterial; Antigens; Biological Factors; Endotoxins; Bacterial Toxins; Toxins, Biological

Study Officials

• Penny M Kris-Etherton, PhD, RD

  Penn State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2011
• First Posted: April 6, 2011
• Study Start: April 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: September 1, 2011
• Last Updated: August 21, 2023

Record last verified: 2023-08

Locations

US (1)