NL-OMON32627
Completed
Not Applicable
The effect of acute moderate alcohol consumption after a psychological stressor on the stress response in men - Effect of acute alcohol consumption after mental tasks
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
- •9\.4 Inclusion criteria
- •1\. Healthy as assessed by the health and lifestyle questionnaire (P8749 F02\), physical examination and results of the pre\-study laboratory tests
- •2\. 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 P8749 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.
- •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.
Exclusion Criteria
- •9\.5 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 psychological disorders or psychiatric, 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.
Investigators
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