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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON33095

Enrollment

Registered

2009-07-09

Start date

2009-08-24

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

inflammation

Interventions

Daily consumption of 100 mL of vodka (30 gram alcohol/day) together with 200 mL orange juice (test) or 200 mL of orange juice (control) for four weeks.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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 (

Design outcomes

Primary

Measure	Time frame
Cytokine response in a human model of low-grade systemic inflammation: - TNF-a and IL-6 response after intravenous (i.v.) LPS administration - Alcohol-induced increase in HDL	—

Secondary

Measure	Time frame
De novo adiponectin protein synthesis rate: Percentage of 14C in adiponectin after i.v. 14C labeled leucine administration Gut microbiota in faeces: Changes in composition of feacal flora and in short chain fatty acids of faeces	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)