Ex Vivo LPS Stimulation in Healthy and Compromised Subjects

June 18, 2013 updated by: W.J. Pasman, TNO

Ex vivo LPS stimulation of whole blood will be a good alternative challenge to induce an inflammatory response and examine differences in the inflammatory response between healthy and compromised subjects.

The purpose of the current study is to examine the inflammatory response in a younger population (35-45 yrs old) to see whether in this population also differences in the ex vivo LPS induced cytokine response exists between healthy and compromised subjects, as is seen in elderly subjects. Overweight subjects showing a state of disturbed blood glucose control will be included as subjects with compromised health and compared to healthy lean subjects with the same age (shifting from healthy towards unhealthy, not diseased).

Hypothesis Ex vivo LPS stimulation of whole blood will induce a measurable inflammatory cytokine response in a healthy population that is different from a response of the compromised population. The investigators will include subjects aged 35-45 years that differ in health characteristics, especially blood HbA1c, fat% and waist circumference.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Zuid-Holland
      • Leiden, Zuid-Holland, Netherlands, 2333 CH
        • CHDR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

In total, 36 male subjects will participate in the study. The study will be conducted in two different subject groups (one healthy and one compromised group), each consisting of 18 subjects.

Description

Inclusion Criteria:

  1. Healthy as assessed by the health and lifestyle questionnaire, physical examination and results of the pre-study laboratory tests;
  2. Males aged between 35-45 years;
  3. Waist circumference: healthy < 94 cm, compromised ≥ 102 cm.
  4. Body composition (InBody 720): body fat % healthy men < 8-19% %; for compromised men > 25%;
  5. HbA1c levels for healthy subjects < 5.5 % or fasting glucose > 3.4 or < 5.6 mmol/L; for compromised HbA1c >=6 and< 6.5% or fasting glucose between 6.1-6.9 mmol/L;
  6. Regular Dutch eating habits as assessed (three main meals, including bread) by health and lifestyle questionnaires.

Exclusion Criteria:

  1. Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study;
  2. Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study, including no blood sampling and/or oral, intravenous, inhalatory administration of substances;
  3. Having a history of medical or surgical events that may significantly affect the study outcome, including any psychiatric history, and metabolic or endocrine disease, or any gastro-intestinal disorder or inflammatory diseases or allergy;
  4. Use of any medication within 14 days before day 01; use of paracetamol within 7 days before day 01;
  5. Currently smoking or stopped smoking less than 6 months ago;
  6. Alcohol consumption >= 21 units per week;
  7. Performing more than 5 hour sports activity per week;
  8. Use of dietary supplements that could affect the inflammatory response (eg fish oil, polyphenols, vitamins);
  9. Not having a general practitioner;
  10. Not willing to accept information transfer which concerns participation in the study, or information regarding health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner;
  11. Not willing to give permission to have the general practitioner to be notified upon participation in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Healthy men
Healthy male subjects with normal weight
Compromised men
pre-diabetic overweight, male subjects

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cytokines
Time Frame: baseline, 4h and 24h incubation with ex vivo LPS
The levels of interleukines present in healthy and compromised subjects will be determined in a baseline sample.
baseline, 4h and 24h incubation with ex vivo LPS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
TNO

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Unilever R&D
Netherlands Metabolomic Center (NMC), The Netherlands

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pierre Peeters, PhD, CHDR Leiden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 3, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 19, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHDR1212

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