NL-OMON33095
Completed
Not Applicable
The effect of moderate alcohol consumption on a human in vivo model of low-grade systemic inflammation in young, normal-weight men - Effect of alcohol consumption on a markers of inflammation
Stichting Alcohol Research0 sites24 target enrollmentStarted: TBDLast updated:
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Stichting Alcohol Research
- Enrollment
- 24
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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.
Investigators
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