The effect of moderate alcohol consumption on a human in vivo model of low-grade systemic inflammation in young, normal-weight me

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 24

Inclusion Criteria

1. Healthy as assessed by the health and lifestyle questionnaire (P8600 F02), physical examination and results of the pre-study laboratory tests
2. Caucasian males aged 21-40 years at Day 01 of the study.
3. Body Mass Index (BMI) of 18 - 27 kg/m2.
4. Alcohol consumption >= 5 and <= 28 standard units/week.
5. Normal Dutch eating habits as assessed by P8600 F02.
6. Voluntary participation.
7. Having given written informed consent.
8. Willing to comply with the study procedures, including refrain from drinking alcoholic drinks other then the alcoholic beverage provided by TNO during the entire study and refrain from fermented dairy and probiotics-containing products.
9. Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data for at least 15 years.
10. Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned.

Exclusion Criteria

Subjects with one or more of the following characteristics will be excluded from participation:
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 or disease that may significantly affect the study outcome, particularly metabolic or endocrine disease and gastrointestinal disorders.
4. Use of medication that may affect the outcome of the study parameters.
5. Having a family history of alcoholism.
6. Smoking.
7. Not having appropriate veins for blood sampling/cannula insertion according to TNO.
8. Reported unexplained weight loss or gain in the month prior to the pre-study screening.
9. Reported slimming or medically prescribed diet.
10. Reported vegan, vegetarian or macrobiotic.
11. Recent blood donation (<1 month prior to the start of the study).
12. Not willing to give up blood donation during the study.
13. Personnel of TNO Quality of Life, their partner and their first and second degree relatives.
14. Not having a general practitioner.
15. 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.
16. Not willing your general practitioner to be notified upon participation in this study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Cytokine response in a human model of low-grade systemic inflammation:<br /><br>- TNF-a and IL-6 response after intravenous (i.v.) LPS administration<br /><br>- Alcohol-induced increase in HDL</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>De novo adiponectin protein synthesis rate:<br /><br>Percentage of 14C in adiponectin after i.v. 14C labeled leucine administration<br /><br><br /><br>Gut microbiota in faeces:<br /><br>Changes in composition of feacal flora and in short chain fatty acids of faeces</p><br>