Trial Outcomes & Findings for Effects of Alcoholic Beverages in Pro-inflammatory and Antioxidant Profile After an Oral Fat Diet (NCT NCT02033174)

NCT ID: NCT02033174

Last Updated: 2017-03-10

Results Overview

In order to determine total antioxidant capacity a quantitative immunoassay using commercial kits (R\&D Systems, Inc. Minneapolis, USA) was conducted.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 16 participants
• Primary outcome timeframe: Baseline and 5 days
• Results posted on: 2017-03-10

Participant Flow

Participant milestones

Measure	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.	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.
First Intervention STARTED	8	8
First Intervention COMPLETED	8	8
First Intervention NOT COMPLETED	0	0
Washout (1 Week) STARTED	8	8
Washout (1 Week) COMPLETED	8	8
Washout (1 Week) NOT COMPLETED	0	0
Second Intervention STARTED	8	8
Second Intervention COMPLETED	8	8
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Alcoholic Beverages in Pro-inflammatory and Antioxidant Profile After an Oral Fat Diet

Baseline characteristics by cohort

Measure	All Participants n=16 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 5 days

Population: All participants who completed all study visits were included

In order to determine total antioxidant capacity a quantitative immunoassay using commercial kits (R&D Systems, Inc. Minneapolis, USA) was conducted.

Outcome measures

Measure	Alcoholic Beverages (Red Wine Intake) n=16 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	Oral Fat Diet n=16 Participants The fat-enriched diet contained 1487 kcal/m2 with 654 kcal/m2 (44%) as fat.
Change From Baseline in Concentrations of Antioxidant Profile After Red Wine Intake	22.3 percentage of change in TAC Interval 19.7 to 25.9	12.7 percentage of change in TAC Interval 8.1 to 20.3

Adverse Events

Alcoholic Beverages

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Oral Fat Diet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Alvarez-Sala

IiSGM

Phone: +34 915868287

Email: luisantonio.alvarezsala@salud.madrid.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place