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
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
-
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.