Ex Vivo LPS Stimulation in Healthy and Compromised Subjects

This study has been completed.
Sponsor:
Collaborators:
Unilever R&D
Netherlands Metabolomic Center (NMC), The Netherlands
Information provided by (Responsible Party):
W.J. Pasman, TNO Quality of Life
ClinicalTrials.gov Identifier:
NCT01656915
First received: June 20, 2012
Last updated: June 18, 2013
Last verified: June 2013
  Purpose

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
Compromised Health
Healthy

Study Type: Observational
Study Design: Observational Model: Case Control
Official Title: Ex Vivo LPS Stimulation in Healthy and Compromised Subjects

Further study details as provided by TNO:

Primary Outcome Measures:
  • Cytokines [ Time Frame: baseline, 4h and 24h incubation with ex vivo LPS ] [ Designated as safety issue: No ]
    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.


Enrollment: 36
Study Start Date: June 2012
Study Completion Date: October 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Healthy men
Healthy male subjects with normal weight
Compromised men
pre-diabetic overweight, male subjects

  Eligibility

Ages Eligible for Study:   35 Years to 45 Years
Genders 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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01656915

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

Publications:
Responsible Party: W.J. Pasman, Principal Investigator, PhD, TNO Quality of Life
ClinicalTrials.gov Identifier: NCT01656915     History of Changes
Other Study ID Numbers: CHDR1212
Study First Received: June 20, 2012
Last Updated: June 18, 2013
Health Authority: Netherlands: Centrale Commissie Mensgebonden Onderzoek

Keywords provided by TNO:
inflammation
response
resilience
cytokines
pre-diabetes

ClinicalTrials.gov processed this record on July 28, 2014