NCT02975856

Brief Summary

The main aim of this study is to evaluate the bioavailability of table red wine and young Port red wine anthocyanins in healthy men.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Dec 2015

Typical duration for phase_1 healthy

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

December 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 29, 2016

Completed
Last Updated

November 29, 2016

Status Verified

November 1, 2016

Enrollment Period

3 months

First QC Date

November 23, 2016

Last Update Submit

November 23, 2016

Conditions

Healthy

Keywords

AnthocyaninsBioavailabilityFlavonoidsPort wineRed wine

Outcome Measures

Primary Outcomes (1)

  • Plasma concentrations of anthocyanins and anthocyanins metabolites

    At baseline and 15, 30, 60 and 120 minutes after wines consumption

Secondary Outcomes (1)

  • Urinary concentrations of anthocyanins and anthocyanins metabolites

    At baseline and 120 minutes after wines consumption

Study Arms (2)

Table Red Wine

EXPERIMENTAL

250 ml Table Red Wine (12% ethanol)

Dietary Supplement: Table Red Wine

Young Port Red Wine

EXPERIMENTAL

150 ml Young Port Red Wine (20% ethanol)

Dietary Supplement: Young Port Red Wine

Interventions

Table Red WineDIETARY_SUPPLEMENT
Table Red Wine
Young Port Red WineDIETARY_SUPPLEMENT
Young Port Red Wine

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men
  • Age 18-65 years
  • BMI \< 25 kg/m2
  • Willing and able to provide written consent

You may not qualify if:

  • Subjects with current or previous CVD, diabetes or other severe chronic disease
  • Subjects under prescription of any chronic medication
  • Intake of red fruits or red wine in the last 24 h prior to the beginning of the intervention
  • Subjects involved in any clinical or food study within the preceding month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CINTESIS - Faculty of Medicine of the University of Porto

Porto, 4200-450, Portugal

Location

Study Officials

  • Conceição Calhau, PhD

    CINTESIS - Faculty of Medicine of University of Porto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2016

First Posted

November 29, 2016

Study Start

December 1, 2015

Primary Completion

March 1, 2016

Study Completion

July 1, 2016

Last Updated

November 29, 2016

Record last verified: 2016-11

Locations

PT(1)