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Effects of Alcoholic Beverages in Pro-inflammatory and Antioxidant Profile After an Oral Fat Diet

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ClinicalTrials.gov Identifier: NCT02033174
Recruitment Status : Completed
First Posted : January 10, 2014
Results First Posted : October 26, 2016
Last Update Posted : March 10, 2017
Sponsor:
Information provided by (Responsible Party):
Luis A. Alvarez-Sala, Instituto de Investigación Sanitaria Gregorio Marañón

Brief 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.

Condition or disease Intervention/treatment Phase
Alcohol Consumption Other: Oral fat diet plus water with sugar Other: Oral fat diet plus alcoholic beverages Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effects of Acute and Chronic Red Wine Intake in the Expression of Pro-inflammatory and Prothrombotic Factors in Circulating Monocytes
Study Start Date : January 2001
Actual Primary Completion Date : July 2001
Actual Study Completion Date : July 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antioxidants

Arm Intervention/treatment
Sugar water first, then alcohol
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)
Other: Oral fat diet plus water with sugar
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.

Other: Oral fat diet plus alcoholic beverages
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.

Alcohol first then sugar water
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).
Other: Oral fat diet plus water with sugar
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.

Other: Oral fat diet plus alcoholic beverages
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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers

Exclusion Criteria:

  • Individuals with a plasma cholesterol level > 220 mg/dl
  • Smokers

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02033174


Locations
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Spain
IiSGM
Madrid, Spain, 28007
Sponsors and Collaborators
Instituto de Investigación Sanitaria Gregorio Marañón
Investigators
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Principal Investigator: Luis A Alvarez-Sala, PhD, MD Head of section. Dep. of Internal Medicine

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Responsible Party: Luis A. Alvarez-Sala, MD, Instituto de Investigación Sanitaria Gregorio Marañón
ClinicalTrials.gov Identifier: NCT02033174    
Other Study ID Numbers: AlcoholInfl_IiSGM_2000
FIS01/0602 ( Other Grant/Funding Number: Fondo de Investigaciones Sanitarias FIS01/0602. )
First Posted: January 10, 2014    Key Record Dates
Results First Posted: October 26, 2016
Last Update Posted: March 10, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Luis A. Alvarez-Sala, Instituto de Investigación Sanitaria Gregorio Marañón:
alcohol, inflammation, oxidation.
Additional relevant MeSH terms:
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Alcohol Drinking
Drinking Behavior
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs