Blackcurrant juice study: a study to investigate the biokinetics and effects of a blackcurrant juice on endothelial function

ISRCTN ISRCTN26166772
DOI https://doi.org/10.1186/ISRCTN26166772
Secondary identifying numbers RDGJUICE08
Submission date
06/08/2010
Registration date
18/08/2010
Last edited
14/11/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Michael Gordon
Scientific

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

Phone +44 (0)118 3786723
Email m.h.gordon@reading.ac.uk

Study information

Study designRandomised double blind placebo controlled crossover acute meal study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeQuality of life
Participant information sheet Not available in web format, please use contact details below to request a patient information sheet
Scientific titleA double blind, randomised, placebo controlled, cross-over study to investigate the biokinetics and effects of a blackcurrant juice on endothelial function
Study objectivesConsumption of 250 ml of a 20% blackcurrant juice drink provides phytochemicals that are absorbed and improve endothelial function in an acute study
Ethics approval(s)The Research Ethics Committee of the University of Reading approved on the 12th of July 2007 (ref: Project 07/26)
Health condition(s) or problem(s) studiedAbsorption of phytochemicals and effects on endothelial function
InterventionOne 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 typeOther
Primary outcome measureEndothelial function/vascular reactivity assessed by laser doppler iontophoresis at 0 and 120 minutes.
Secondary outcome measuresPhytochemical 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 study start date04/12/2007
Completion date05/06/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants20
Key inclusion criteria1. 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)
Key exclusion criteria1. 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)
Date of first enrolment04/12/2007
Date of final enrolment05/06/2008

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

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

Sponsor information

GlaxoSmithKline Nutritional Healthcare (UK)
Industry

980 Great West Road
Brentford
TW8 9GS
United Kingdom

ROR logo "ROR" https://ror.org/01xsqw823

Funders

Funder type

Industry

SmithKline Beecham plc (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/07/2011 Yes No