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| ID | Type | Description | Link |
|---|---|---|---|
| FIS01/0602 | Other Grant/Funding Number | Fondo de Investigaciones Sanitarias FIS01/0602. |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sugar water first, then alcohol | Other | 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) |
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| Alcohol first then sugar water | Other | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral fat diet plus water with sugar | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 5 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luis A Alvarez-Sala, PhD, MD | Head of section. Dep. of Internal Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IiSGM | Madrid | Madrid | 28007 | Spain |
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| ID | Title | Description |
|---|---|---|
| FG000 | Alcohol First, Then Sugar Water | Participants first received an oral fat-enriched diet (1486 kcal/m2) and a daily total amount of 16 g/m2 of alcohol, of different beverages (red wine, vodka, brandy or rum) for 5 days. Then, they received equivalent caloric intakes as sugar with water in the control group for 5 days. |
| FG001 | Sugar Water First ,Then Alcohol | Participants first received an oral fat-enriched diet (1486 kcal/m2) and sugar with water for 5 days. They then received a daily total amount of 16 g/m2 of alcohol, of different beverages (red wine, vodka, brandy or rum) for 5 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| |||||||||||||
| Washout (1 Week) |
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| Second Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All participants who completed all study visits were included | Posted | Median | Inter-Quartile Range | percentage of change in TAC | Baseline and 5 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Alcoholic Beverages | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Alvarez-Sala | IiSGM | +34 915868287 | luisantonio.alvarezsala@salud.madrid.org |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014867 | Water |
| D000073893 | Sugars |
| D000434 | Alcoholic Beverages |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 |
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| Oral fat diet plus alcoholic beverages | Other | 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. |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
The fat-enriched diet contained 1487 kcal/m2 with 654 kcal/m2 (44%) as fat.
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|
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| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Oral Fat Diet | Oral fat diet contained 1487 kcal/m2 with 654 kcal/m2 (44%) as fat. | 0 | 16 | 0 | 16 |
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| Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D002241 | Carbohydrates |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |