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AzTrials

Alcohol ConsumptionAR23NCT00918918

Effect of Alcohol Consumption on Markers of Inflammation

A study testing Alcohol + orange juice and Orange juice in people with Alcohol Consumption and Inflammation, run by TNO at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 40 years, men onlyHealthy volunteers can take part
Conditions the study is for
Alcohol Consumption, Inflammation
What is being tested?
Alcohol + orange juice and Orange juice
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteNetherlands
Study dates
Aug 2009to Nov 2009
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 40 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • 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.
  • Not willing your general practitioner to be notified upon participation in this study

Trial locations and contacts

1 site in 1 country.

Netherlands1 site
  • TNO Quality of Life

    Zeist, 3704HE

Other trials in Netherlands

About this study

Official title: The Effect of Moderate Alcohol Consumption on a Human in Vivo Model of Low-grade Systemic Inflammation in Young, Normal-weight Men

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.

Read the detailed description

Cytokine response in a human model of low-grade systemic inflammation Lipopolysaccharide (LPS) or endotoxin is a constituent of the Gram-negative bacterial cell wall. It circulates in the plasma of healthy human subjects at low concentrations (between 1 and 200 pg/mL). Furthermore, the human gut is host to ~100 trillion organisms, which together contribute to an enteric reservoir of ~1 g LPS (4).

Upon introduction in the bloodstream endotoxin binds to LPS-binding protein (LBP) and this complex binds to CD14 on monocytes. CD14 does not have an intracellular domain but signals through Toll-like receptor 4, leading eventually to activation of the transcription factor NF-κB and to production of Tumor Necrosis Factor alpha (TNF-α,) and interleukin 6 (IL-6) and a systemic inflammatory response.

Endotoxin administration to humans, when given in a low dose, is a well-established model of systemic inflammation (5). The low dose of endotoxin elicits an acute mild systemic inflammation with a significant and reproducible cytokine and leucocyte response without increases in body temperature (2;3). This model thus resembles the levels reported in chronic low-grade inflammatory conditions such as type 2 diabetes and arthrosclerosis.

High-density lipoprotein (HDL) is a group of lipoprotein particles which have the highest density in the circulation. HDL has several anti-atherogenic effects, including the ability to transport excess cellular cholesterol to the liver for excretion, to protect low-density lipoprotein (LDL) against oxidation and to inhibit platelet aggregation. Besides its pivotal role in protecting against atherosclerosis, accumulating evidence also suggest that HDL possesses anti-inflammatory effects and plays an important role in modulating the inflammatory response to lipopolysaccharides.

Although all lipoprotein classes have been demonstrated to bind LPS, when added to whole human normal blood, it mainly binds to HDL (60%), in addition to LDL (25%) and VLDL (12%) (6). In vitro, LPS bound to lipoprotein was 20- to 1000-fold less active than the unbound form in inducing monocytes and macrophages to release cytokines (7). When transgenic mice with 2-fold elevation of plasma HDL levels were injected with LPS, they had more LPS bound to HDL, lower plasma cytokine levels, and improved survival rates compared with control mice (8). In humans Ex vivo reconstituted HDL abolished the LPS-induced overproduction of cytokines in patients with severe cirrhosis and controls (9) and intravenous infusion of reconstituted HDL protected humans from the toxic effects of LPS (10).

It has never been studied whether the alcohol-induced increase in HDL could attenuate the effects of LPS on cytokine response both ex vivo and in vivo. Given the fact that alcohol induces an increase in HDL (1) and that HDL has LPS-neutralizing properties, it is hypothesized that moderate alcohol consumption attenuates the LPS-induced cytokine response of TNF-α and IL-6 in young, normal-weight men.

In addition, because HDL causes down regulation of CD14 expression in monocytes (10) and because CD14 modulates the pro-inflammatory response to LPS (11), the effects of HDL on CD14 expression and expression of other genes related to inflammation will be determined in monocytes over time after both in vivo and ex vivo LPS administration. Since HDL also affects endothelial function (12;13) and since eicosanoids are important messengers during systemic inflammatory processes (14) these markers will also be investigated.

Being tested
Alcohol + orange juice, Orange juice
Keywords
Alcohol Consumption, High Density Lipoprotein (HDL), lipopolysaccharides (LPS), Apolipoproteins, Inflammation
Medical subject headings
Alcohol Drinking, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Alcohol + orange juiceDietary supplement

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

  • Orange juiceDietary supplement

    200 mL orange juice

Study groups in NCT00918918
Study groupRoleWhat they receive
Treatment BExperimentalVodka + orange juice
Receives: Dietary Supplement: Alcohol + orange juice
Treatment APlacebo comparatorOrange juice
Receives: Dietary Supplement: Orange juice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. In vivo cytokine response after low-dose LPS challenge

    Measured: December 2009

Secondary outcomes (2)
  1. de novo adiponectin protein synthesis

    Measured: December 2010

  2. changes in microbiota

    Measured: December 2010

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2009 (estimated)
  2. Study startAug 2009
  3. Primary completionNov 2009
  4. Study completionNov 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00918918
Sponsor's protocol ID
P8600
Acronym
AR23
Status last verified
Nov 2009
First submitted
10 Jun 2009
Last updated
25 Nov 2009
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24548643

Questions about this trial

What is this clinical trial studying?

A study testing Alcohol + orange juice and Orange juice in people with Alcohol Consumption and Inflammation, run by TNO at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In vivo cytokine response after low-dose LPS challenge (time frame: December 2009). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00918918, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2009.

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