Condition category
Nutritional, Metabolic, Endocrine
Date applied
06/08/2010
Date assigned
18/08/2010
Last edited
14/11/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Michael Gordon

ORCID ID

Contact details

Hugh Sinclair Unit of Human Nutrition
Department of Food and Nutritional Sciences
The University of Reading
Whiteknights
PO Box 226
Reading
RG6 6AP
United Kingdom
+44 (0)118 3786723
m.h.gordon@reading.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RDGJUICE08

Study information

Scientific title

A double blind, randomised, placebo controlled, cross-over study to investigate the biokinetics and effects of a blackcurrant juice on endothelial function

Acronym

Study hypothesis

Consumption of 250 ml of a 20% blackcurrant juice drink provides phytochemicals that are absorbed and improve endothelial function in an acute study

Ethics approval

The Research Ethics Committee of the University of Reading approved on the 12th of July 2007 (ref: Project 07/26)

Study design

Randomised double blind placebo controlled crossover acute meal study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

Absorption of phytochemicals and effects on endothelial function

Intervention

One dose of 250 ml of a 20% blackcurrant juice drink in comparison with a control drink lacking flavonoids.
The washout period between the intervention and control dose was 1 month.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Endothelial function/vascular reactivity assessed by laser doppler iontophoresis at 0 and 120 minutes.

Secondary outcome measures

Phytochemical composition (phenolic acids and flavonoids) of plasma and urine was measured at 0.5 hour intervals for the first 4 hours, then 1 hour intervals up to 8 hours. A 24 hour urine sample was also analysed.

Overall trial start date

04/12/2007

Overall trial end date

05/06/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Men and women between the ages of 30-70 years
2. Normal weight
3. Drink no more than 15 units of alcohol (i.e. not more than 7 pints) per week
4. Not regularly undertaking vigorous exercise or fitness training (i.e. not more than 3, 20 minute aerobic sessions per week)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant exclusion criteria

1. Diabetes
2. Heart disease
3. Gall bladder problems
4. Phenylketonuria (PKU)
5. Known food allergies or intolerances or abnormalities of fat metabolism
6. Trying to lose weight or following other diets
7. Taking dietary supplements
8. Hormone abnormalities or liver disease
9. Regularly use certain types of medication
10. Pregnant, lactating or, if female and of reproductive age, not using a reliable form of contraception (including abstinence)

Recruitment start date

04/12/2007

Recruitment end date

05/06/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Hugh Sinclair Unit of Human Nutrition,
Reading
RG6 6AP
United Kingdom

Sponsor information

Organisation

GlaxoSmithKline Nutritional Healthcare (UK)

Sponsor details

980 Great West Road
Brentford
TW8 9GS
United Kingdom

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

SmithKline Beecham plc (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21540876

Publication citations

  1. Results

    Jin Y, Alimbetov D, George T, Gordon MH, Lovegrove JA, A randomised trial to investigate the effects of acute consumption of a blackcurrant juice drink on markers of vascular reactivity and bioavailability of anthocyanins in human subjects., Eur J Clin Nutr, 2011, 65, 7, 849-856, doi: 10.1038/ejcn.2011.55.

Additional files

Editorial Notes