Ex Vivo LPS Stimulation in Healthy and Compromised Subjects

Healthy Clinical Trial

Official title:

Ex Vivo LPS Stimulation in Healthy and Compromised Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01656915
• Other study ID #: CHDR1212
• Status: Completed
• Phase: N/A
• First received: June 20, 2012
• Last updated: June 18, 2013
• Start date: June 2012
• Est. completion date: October 2012

Study information

• Verified date: June 2013
• Source: TNO
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Centrale Commissie Mensgebonden Onderzoek
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: October 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 35 Years to 45 Years

Eligibility

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 Design

Observational Model: Case Control

Related Conditions & MeSH terms

• Compromised Health
• Healthy

Locations

Country	Name	City	State
Netherlands	CHDR	Leiden	Zuid-Holland

Sponsors (3)

Lead Sponsor	Collaborator
TNO	Netherlands Metabolomic Center (NMC), The Netherlands, Unilever R&D

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Wijsman CA, Maier AB, de Craen AJ, van den Biggelaar AH, Westendorp RG. An unopposed proinflammatory response is beneficial for survival in the oldest old. Results of the Leiden 85-plus Study. J Gerontol A Biol Sci Med Sci. 2011 Apr;66(4):393-9. doi: 10.1093/gerona/glq212. Epub 2010 Dec 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cytokines	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	No