Alcohol Consumption
Conditions
Keywords
alcohol, inflammation, oxidation.
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.
Interventions
OTHEROral 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.
OTHEROral 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.
Sponsors
Instituto de Investigación Sanitaria Gregorio Marañón
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy volunteers
Exclusion criteria
* Individuals with a plasma cholesterol level \> 220 mg/dl * Smokers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Concentrations of Antioxidant Profile After Red Wine Intake | 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. |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants Cross over study over five different weeks. 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. | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 16 | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 |
Outcome results
Primary
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
Population: All participants who completed all study visits were included
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Alcoholic Beverages (Red Wine Intake) | Change From Baseline in Concentrations of Antioxidant Profile After Red Wine Intake | 22.3 percentage of change in TAC |
| Oral Fat Diet | Change From Baseline in Concentrations of Antioxidant Profile After Red Wine Intake | 12.7 percentage of change in TAC |
p-value: 0.05Kruskal-Wallis