Alcohol ConsumptionNCT02033174
Effects of Alcoholic Beverages in Pro-inflammatory and Antioxidant Profile After an Oral Fat Diet
A study testing Oral fat diet plus water with sugar and Oral fat diet plus alcoholic beverages in people with Alcohol Consumption, run by Instituto de Investigación Sanitaria Gregorio Marañón at 1 site in Spain.
Trial summary
Hypothesis: Red wine intake but not other alcoholic beverages together with a fat diet will decrease inflammatory factors and lipid peroxidation and decrease antioxidant capacity in healthy people after a five days period. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Consumption
- What is being tested?
- Oral fat diet plus water with sugar and Oral fat diet plus alcoholic beverages
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2001to Jul 2001
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers
Who cannot join
- Individuals with a plasma cholesterol level > 220 mg/dl
- Smokers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Acute and Chronic Red Wine Intake in the Expression of Pro-inflammatory and Prothrombotic Factors in Circulating Monocytes
Hypothesis: Red wine intake but not other alcoholic beverages together with a fat diet will decrease inflammatory factors and lipid peroxidation and decrease antioxidant capacity in healthy people after a five days period.
- Conditions
- Alcohol Consumption
- Being tested
- Oral fat diet plus water with sugar, Oral fat diet plus alcoholic beverages
- Keywords
- alcohol, inflammation, oxidation.
- 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.
Oral fat diet plus water with sugarOther
All participants were assigned to receive and oral fat diet plus sugar water. Oral fat diet contained 1487 kcal/m2 with 654 kcal/m2 (44%) as fat. Sugar water has equivalent caloric intakes as alcoholic beverages.
Oral fat diet plus alcoholic beveragesOther
Oral fat diet contained 1487 kcal/m2 with 654 kcal/m2 (44%) as fat. In all cases, alcohol represented a daily total amount of 16 g/m2. The content of alcohol was 12% in red wine, 37% in rum, and 35% in brandy.Vodka was tri-distilled and contained 40% alcohol.
| Study group | Role | What they receive |
|---|---|---|
| Sugar water first, then alcohol | Other | 8 participants have received oral fat diet plus water with sugar (equivalent caloric intakes as sugar with water in the control group). Then they receive the same oral fat-enriched diet (1486 kcal/m2) with 654 kcal/m2 (44%) as fat and a daily total amount of 16 g/m2 of alcohol, of different beverages (red wine, vodka, brandy or rum) Receives: Other: Oral fat diet plus water with sugar; Other: Oral fat diet plus alcoholic beverages |
| Alcohol first then sugar water | Other | 8 participants have received oral fat diet plus alcoholic beverages (a daily total amount of 16 g/m2 of alcohol, of different beverages : red wine, vodka, brandy or rum). Then they receive the same oral fat-enriched diet (1486 kcal/m2) with 654 kcal/m2 (44%) as fat and water with sugar (equivalent caloric intakes as sugar with water in the control group). Receives: Other: Oral fat diet plus water with sugar; Other: Oral fat diet plus alcoholic beverages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Concentrations of Antioxidant Profile After Red Wine Intake
In order to determine total antioxidant capacity a quantitative immunoassay using commercial kits (R\&D Systems, Inc. Minneapolis, USA) was conducted.
Measured: Baseline and 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2014 (estimated)
- Study startJan 2001
- Primary completionJul 2001
- Study completionJul 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol ConsumptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria Gregorio Marañón
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis A. Alvarez-Sala, Instituto de Investigación Sanitaria Gregorio Marañón
- Investigators
- Luis A Alvarez-Sala, PhD, MD, Principal investigator, Head of section. Dep. of Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02033174
- Sponsor's protocol ID
- AlcoholInfl_IiSGM_2000
- Other IDs
- FIS01/0602
- Status last verified
- Jan 2017
- First submitted
- 9 Jan 2014
- Last updated
- 10 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Acute and Chronic Red Wine Intake in the Expression of Pro-inflammatory and Prothrombotic Factors in Circulating Monocytes
- ClinicalTrials.gov ID
- NCT02033174
- Acronym / sponsor ID
- AlcoholInfl_IiSGM_2000
- Conditions
- Alcohol Consumption
- Keywords
- alcohol, inflammation, oxidation.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Instituto de Investigación Sanitaria Gregorio MarañónUniversity, hospital or other
- Study start
- Jan 2001
- Primary completion
- Jul 2001 (actual)
- Study completion
- Jul 2001 (actual)
- First posted
- 10 Jan 2014 (estimated)
- Results
- Posted 26 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypothesis: Red wine intake but not other alcoholic beverages together with a fat diet will decrease inflammatory factors and lipid peroxidation and decrease antioxidant capacity in healthy people after a five days period.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugar water first, then alcohol | Other | Other: Oral fat diet plus water with sugar, Other: Oral fat diet plus alcoholic beverages8 participants have received oral fat diet plus water with sugar (equivalent caloric intakes as sugar with water in the control group). Then they receive the same oral fat-enriched diet (1486 kcal/m2) with 654 kcal/m2 (44%) as fat and a daily total amount of 16 g/m2 of alcohol, of different beverages (red wine, vodka, brandy or rum) |
| Alcohol first then sugar water | Other | Other: Oral fat diet plus water with sugar, Other: Oral fat diet plus alcoholic beverages8 participants have received oral fat diet plus alcoholic beverages (a daily total amount of 16 g/m2 of alcohol, of different beverages : red wine, vodka, brandy or rum). Then they receive the same oral fat-enriched diet (1486 kcal/m2) with 654 kcal/m2 (44%) as fat and water with sugar (equivalent caloric intakes as sugar with water in the control group). |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy volunteers
Key exclusion criteria (2 listed)
- Individuals with a plasma cholesterol level > 220 mg/dl
- Smokers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral fat diet plus water with sugarAll participants were assigned to receive and oral fat diet plus sugar water. Oral fat diet contained 1487 kcal/m2 with 654 kcal/m2 (44%) as fat. Sugar water has equivalent caloric intakes as alcoholic beverages. | Other | Alcohol first then sugar water, Sugar water first, then alcohol |
| Oral fat diet plus alcoholic beveragesOral fat diet contained 1487 kcal/m2 with 654 kcal/m2 (44%) as fat. In all cases, alcohol represented a daily total amount of 16 g/m2. The content of alcohol was 12% in red wine, 37% in rum, and 35% in brandy.Vodka was tri-distilled and contained 40% alcohol. | Other | Alcohol first then sugar water, Sugar water first, then alcohol |
Primary outcome
Change From Baseline in Concentrations of Antioxidant Profile After Red Wine Intake
Time frame: Baseline and 5 days
In order to determine total antioxidant capacity a quantitative immunoassay using commercial kits (R\&D Systems, Inc. Minneapolis, USA) was conducted.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis A Alvarez-Sala, PhD, MD principal investigator
Head of section. Dep. of Internal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral fat diet plus water with sugar and Oral fat diet plus alcoholic beverages in people with Alcohol Consumption, run by Instituto de Investigación Sanitaria Gregorio Marañón at 1 site in Spain.
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 1 inclusion and 2 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 10 Mar 2017. 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 Spain. 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. 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?
Yes. Results are posted in the registry (first posted 26 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Concentrations of Antioxidant Profile After Red Wine Intake (time frame: Baseline and 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2017.