- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02033174
Effects of Alcoholic Beverages in Pro-inflammatory and Antioxidant Profile After an Oral Fat Diet
January 23, 2017 updated by: Luis A. Alvarez-Sala, Instituto de Investigación Sanitaria Gregorio Marañón
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Madrid, Spain, 28007
- IiSGM
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy volunteers
Exclusion Criteria:
- Individuals with a plasma cholesterol level > 220 mg/dl
- Smokers
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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)
|
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 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
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).
|
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 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline and 5 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Luis A Alvarez-Sala, PhD, MD, Head of section. Dep. of Internal Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2001
Primary Completion (Actual)
July 1, 2001
Study Completion (Actual)
July 1, 2001
Study Registration Dates
First Submitted
January 9, 2014
First Submitted That Met QC Criteria
January 9, 2014
First Posted (Estimate)
January 10, 2014
Study Record Updates
Last Update Posted (Actual)
March 10, 2017
Last Update Submitted That Met QC Criteria
January 23, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AlcoholInfl_IiSGM_2000
- FIS01/0602 (Other Grant/Funding Number: Fondo de Investigaciones Sanitarias FIS01/0602.)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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