Ex Vivo LPS Stimulation in Healthy and Compromised Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01656915
Recruitment Status : Completed
First Posted : August 3, 2012
Last Update Posted : June 19, 2013
Unilever R&D
Netherlands Metabolomic Center (NMC), The Netherlands
Information provided by (Responsible Party):
W.J. Pasman, TNO

Brief Summary:

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.

Condition or disease
Compromised Health Healthy

Study Type : Observational
Actual Enrollment : 36 participants
Observational Model: Case Control
Official Title: Ex Vivo LPS Stimulation in Healthy and Compromised Subjects
Study Start Date : June 2012
Actual Primary Completion Date : August 2012
Actual Study Completion Date : October 2012

Healthy men
Healthy male subjects with normal weight
Compromised men
pre-diabetic overweight, male subjects

Primary Outcome Measures :
  1. 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.

Biospecimen Retention:   Samples Without DNA
Blood samples will be obtained for standard clinical chemistry, heamatology, cytokines and ex vivo LPS stimulation.

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Ages Eligible for Study:   35 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01656915

Leiden, Zuid-Holland, Netherlands, 2333 CH
Sponsors and Collaborators
Unilever R&D
Netherlands Metabolomic Center (NMC), The Netherlands
Principal Investigator: Pierre Peeters, PhD CHDR Leiden

Responsible Party: W.J. Pasman, Principal Investigator, PhD, TNO Identifier: NCT01656915     History of Changes
Other Study ID Numbers: CHDR1212
First Posted: August 3, 2012    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: June 2013

Keywords provided by W.J. Pasman, TNO: