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 |
| Protocol serial number | RDGJUICE08 |
| Sponsor | GlaxoSmithKline Nutritional Healthcare (UK) |
| Funder | SmithKline Beecham plc (UK) |
- 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
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 |
|---|---|
| m.h.gordon@reading.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double blind placebo controlled crossover acute meal study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A double blind, randomised, placebo controlled, cross-over study to investigate the biokinetics and effects of a blackcurrant juice on endothelial function |
| Study objectives | 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(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) studied | 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 |
| Primary outcome measure(s) |
Endothelial function/vascular reactivity assessed by laser doppler iontophoresis at 0 and 120 minutes. |
| Key secondary outcome measure(s) |
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. |
| Completion date | 05/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 20 |
| Key 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) |
| Key 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) |
| Date of first enrolment | 04/12/2007 |
| Date of final enrolment | 05/06/2008 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Hugh Sinclair Unit of Human Nutrition,
Reading
RG6 6AP
United Kingdom
RG6 6AP
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
