Back to resultsEffects of Alcoholic Beverages in Pro-inflammatory and Antioxidant Profile After an Oral Fat Diet
Primary Purpose
Alcohol Consumption
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Oral fat diet plus water with sugar
Oral fat diet plus alcoholic beverages
Sponsored by
About this trial
This is an interventional basic science trial for Alcohol Consumption focused on measuring alcohol, inflammation, oxidation.
Eligibility Criteria
Inclusion Criteria:
- Healthy volunteers
Exclusion Criteria:
- Individuals with a plasma cholesterol level > 220 mg/dl
- Smokers
Sites / Locations
- IiSGM
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Sugar water first, then alcohol
Alcohol first then sugar water
Arm Description
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)
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).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02033174
First Posted
January 9, 2014
Last Updated
January 23, 2017
Sponsor
Instituto de Investigación Sanitaria Gregorio Marañón
1. Study Identification
Unique Protocol Identification Number
NCT02033174
Brief Title
Effects of Alcoholic Beverages in Pro-inflammatory and Antioxidant Profile After an Oral Fat Diet
Official Title
Effects of Acute and Chronic Red Wine Intake in the Expression of Pro-inflammatory and Prothrombotic Factors in Circulating Monocytes
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
July 2001 (Actual)
Study Completion Date
July 2001 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto de Investigación Sanitaria Gregorio Marañón
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Consumption
Keywords
alcohol, inflammation, oxidation.
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sugar water first, then alcohol
Arm Type
Other
Arm Description
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)
Arm Title
Alcohol first then sugar water
Arm Type
Other
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Oral fat diet plus water with sugar
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Oral fat diet plus alcoholic beverages
Intervention Description
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 Measure Information:
Title
Change From Baseline in Concentrations of Antioxidant Profile After Red Wine Intake
Description
In order to determine total antioxidant capacity a quantitative immunoassay using commercial kits (R&D Systems, Inc. Minneapolis, USA) was conducted.
Time Frame
Baseline and 5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy volunteers
Exclusion Criteria:
Individuals with a plasma cholesterol level > 220 mg/dl
Smokers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis A Alvarez-Sala, PhD, MD
Organizational Affiliation
Head of section. Dep. of Internal Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
IiSGM
City
Madrid
ZIP/Postal Code
28007
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Alcoholic Beverages in Pro-inflammatory and Antioxidant Profile After an Oral Fat Diet
We'll reach out to this number within 24 hrs