Effect of Alcohol Consumption on Markers of Inflammation

NCT00918918 | Completed DMC

• 1 other identifier: P8600
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: High-density lipoprotein (HDL), which is consistently increased after moderate alcohol consumption, is an abundant plasma lipoprotein that is generally thought to be anti-inflammatory in both health and infectious disease. HDL binds and neutralizes the bioactivity of potent bacterial remnants such as lipopolysaccharides (LPS) which stimulate the host innate immune responses. Primary objective: To explore whether prolonged moderate alcohol consumption affects in vivo cytokine response after a low dose of LPS in young, normal-weight men.

Conditions

Alcohol Consumption; Inflammation

Keywords

Alcohol Consumption; High Density Lipoprotein (HDL); lipopolysaccharides (LPS); Apolipoproteins; Inflammation

Outcome Measures

Primary Outcomes (1)

• In vivo cytokine response after low-dose LPS challenge

  December 2009

Secondary Outcomes (2)

• de novo adiponectin protein synthesis

  December 2010

• changes in microbiota

  December 2010

Study Arms (2)

Treatment B

EXPERIMENTAL

Vodka + orange juice

Dietary Supplement: Alcohol + orange juice

Treatment A

PLACEBO COMPARATOR

Orange juice

Dietary Supplement: Orange juice

Interventions

Alcohol + orange juice DIETARY_SUPPLEMENT

100 mL Vodka (37.5 vol%; 30 gram of alcohol/day) + 200 mL orange juice

Treatment B

Orange juice DIETARY_SUPPLEMENT

200 mL orange juice

Treatment A

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy as assessed by the health and lifestyle questionnaire (P8600 F02), physical examination and results of the pre-study laboratory tests
• Males aged 21-40 years at Day 01 of the study.
• Body Mass Index (BMI) of 18 - 27 kg/m2.
• Alcohol consumption ≥ 5 and ≤ 28 standard units/week.
• Normal eating habits as assessed by P8600 F02.
• Voluntary participation.
• Having given written informed consent.
• 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.
• Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data for at least 15 years.
• Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned.

You may not qualify if:

• Subjects with one or more of the following characteristics will be excluded from participation:
• Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study.
• 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.
• 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.
• Use of medication that may affect the outcome of the study parameters.
• Having a family history of alcoholism.
• Smoking.
• Not having appropriate veins for blood sampling/cannula insertion according to TNO.
• Reported unexplained weight loss or gain in the month prior to the pre-study screening.
• Reported slimming or medically prescribed diet.
• Reported vegan, vegetarian or macrobiotic.
• Recent blood donation (\<1 month prior to the start of the study).
• Not willing to give up blood donation during the study.
• Personnel of TNO Quality of Life, their partner and their first and second degree relatives.
• Not having a general practitioner.

Sponsors & Collaborators

• TNO: lead

Study Sites (1)

TNO Quality of Life

Zeist, 3704HE, Netherlands

Location

Related Publications (1)

• Joosten MM, Schrieks IC, Hendriks HF. Effect of moderate alcohol consumption on fetuin-A levels in men and women: post-hoc analyses of three open-label randomized crossover trials. Diabetol Metab Syndr. 2014 Feb 18;6(1):24. doi: 10.1186/1758-5996-6-24.

  PMID: 24548643 DERIVED

MeSH Terms

Conditions

Alcohol Drinking; Inflammation

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Henk FJ Hendriks, PhD

  TNO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 10, 2009
• First Posted: June 11, 2009
• Study Start: August 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: November 25, 2009

Record last verified: 2009-11

Locations

NL (1)