NCT00937313

Brief Summary

  • To assess whether acute, moderate Champagne wine consumption modulates endothelial function in healthy human volunteers.
  • To establish the bioavailability of Champagne wine polyphenols and their metabolism.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2007

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

July 1, 2007

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 13, 2009

Completed
Last Updated

July 13, 2009

Status Verified

July 1, 2009

Enrollment Period

7 months

First QC Date

July 10, 2009

Last Update Submit

July 10, 2009

Conditions

No Condition. Assessment of Healthy Volunteers.

Outcome Measures

Primary Outcomes (1)

  • Assessment of endothelial function by Laser Doppler Imaging with iontophoresis. Blood Assessment of lipid profile, inflammatory markers, plasma antioxidant and oxidant capacity, liver enzyme and metalloproteinase blood concentrations.

    6 months

Secondary Outcomes (1)

  • Bioavailability of phytochemicals and metabolite excretion.

    6 months

Study Arms (2)

Champagne wine

Other: Champagne wine intervention

Placebo

alcohol with sparkling mineral water

Other: Champagne wine intervention

Interventions

Champagne wine interventionOTHER

Placebo-controlled randomised cross-over human trial

Also known as: Non applicable
Champagne winePlacebo

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy volunteers

You may qualify if:

  • Healthy male and female subjects, aged between 20 and 65 years, with a Body Mass Index (BMI) between 19 and 25 kg/m². Normal concentrations of liver enzymes (AST, ALT, gamma GT), normal hemoglobin, hematocrit and leucocyte counts and an absence of glucose and protein in urine

You may not qualify if:

  • Individuals with diabetes, any form of liver or gastrointestinal disorder, low BMI (\<19), high blood pressure (\>150/90 mm/Hg), anaemia, gall bladder problems, present illness, or those taking dietary supplements, vigorous exercise (\> 3 x 20 min/week), or alcohol consumption more than 120 g (women) and 168 g (men) per week , pregnant or lactating females.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Food and Nutritional Sciences

Reading, Berkshire, RG6 6AP, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma serum urine

Study Officials

  • Jeremy PE Spencer, PhD

    The University of Reading

    PRINCIPAL INVESTIGATOR

  • David Vauzour, PhD

    The University of Reading

    PRINCIPAL INVESTIGATOR

  • Julie Lovegrove, PhD

    The University of Reading

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 10, 2009

First Posted

July 13, 2009

Study Start

July 1, 2007

Primary Completion

February 1, 2008

Study Completion

September 1, 2008

Last Updated

July 13, 2009

Record last verified: 2009-07

Locations

GB(1)