An interventional study of Oral fat diet plus water with sugar and Oral fat diet plus alcoholic beverages in Alcohol Consumption, sponsored by Instituto de Investigación Sanitaria Gregorio Marañón. Completed at 1 site in Spain. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-10.
Sponsored by Instituto de Investigación Sanitaria Gregorio Marañón · Not applicable, Interventional, and Basic science
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.
925 studies on the registry are indexed under Alcohol Drinking; 172 are open to participants now.
This study's enrollment of 16 is below the median of 108 across 802 interventional studies indexed under Alcohol Drinking.
Browse Alcohol Drinking studies →Instituto de Investigación Sanitaria Gregorio Marañón is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Other: Oral fat diet plus alcoholic beverages
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 · Other: Oral fat diet plus alcoholic beverages
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.
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.
Time frame: Baseline and 5 days
| Milestone | Alcohol First, Then Sugar Water | Sugar Water First ,Then Alcohol |
|---|---|---|
| Started | 8 | 8 |
| Completed | 8 | 8 |
| Not completed | 0 | 0 |
| Milestone | Alcohol First, Then Sugar Water | Sugar Water First ,Then Alcohol |
|---|---|---|
| Started | 8 | 8 |
| Completed | 8 | 8 |
| Not completed | 0 | 0 |
| Milestone | Alcohol First, Then Sugar Water | Sugar Water First ,Then Alcohol |
|---|---|---|
| Started | 8 | 8 |
| Completed | 8 | 8 |
| Not completed | 0 | 0 |
In order to determine total antioxidant capacity a quantitative immunoassay using commercial kits (R\&D Systems, Inc. Minneapolis, USA) was conducted.
| percentage of change in TAC | Alcoholic Beverages (Red Wine Intake) | Oral Fat Diet |
|---|---|---|
| Change From Baseline in Concentrations of Antioxidant Profile After Red Wine Intake | 22.3 (19.7 to 25.9) | 12.7 (8.1 to 20.3) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Alcoholic Beverages | — | 0/16 (0%) | 0/16 (0%) |
| Oral Fat Diet | — | 0/16 (0%) | 0/16 (0%) |
| Age, Categorical(Participants) | All Participants |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 16 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 8 |
| Male | 8 |
| Race (NIH/OMB)(Participants) | All Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 16 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
Plan to share: No
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Instituto de Investigación Sanitaria Gregorio Marañón