NCT02033174

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2001

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2001

Completed
12.5 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 10, 2014

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

October 26, 2016

Completed
Last Updated

March 10, 2017

Status Verified

January 1, 2017

Enrollment Period

6 months

First QC Date

January 9, 2014

Results QC Date

February 28, 2016

Last Update Submit

January 23, 2017

Conditions

Alcohol Consumption

Keywords

alcohol, inflammation, oxidation.

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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)

Other: Oral fat diet plus water with sugarOther: Oral fat diet plus alcoholic beverages

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).

Other: Oral fat diet plus water with sugarOther: Oral fat diet plus alcoholic beverages

Interventions

Oral fat diet plus water with sugarOTHER

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.

Alcohol first then sugar waterSugar water first, then alcohol
Oral fat diet plus alcoholic beveragesOTHER

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.

Alcohol first then sugar waterSugar water first, then alcohol

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers

You may not qualify if:

  • Individuals with a plasma cholesterol level \> 220 mg/dl
  • Smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IiSGM

Madrid, Madrid, 28007, Spain

Location

MeSH Terms

Conditions

Alcohol DrinkingInflammation

Interventions

WaterSugarsAlcoholic Beverages

Condition Hierarchy (Ancestors)

Drinking BehaviorBehaviorPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen CompoundsCarbohydratesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Results Point of Contact

Title
Dr Alvarez-Sala
Organization
IiSGM
luisantonio.alvarezsala@salud.madrid.org
+34 915868287

Study Officials

  • Luis A Alvarez-Sala, PhD, MD

    Head of section. Dep. of Internal Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 9, 2014

First Posted

January 10, 2014

Study Start

January 1, 2001

Primary Completion

July 1, 2001

Study Completion

July 1, 2001

Last Updated

March 10, 2017

Results First Posted

October 26, 2016

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)