Flavonoids Kinetics Study

ISRCTN	ISRCTN36287115
DOI	https://doi.org/10.1186/ISRCTN36287115
Secondary identifying numbers	N/A

Submission date: 10/03/2011
Registration date: 01/07/2011
Last edited: 19/05/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Julie Lovegrove
Scientific

Department of Food and Nutritional Sciences
University of Reading
Whiteknights
Reading
RG6 6AP
United Kingdom

Study information

Study design	Randomised controlled single-blind intervention study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Screening
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	The effect of an acute ingestion of a flavonoid-rich fruit and vegetable puree based drink on vasodilation and other risk factors of cardiovascular disease in healthy individuals
Study acronym	FlaKS
Study objectives	Consumption of a flavonoid-rich fruit and vegetable puree-based drink will acutely increase endothelium-dependent vasodilation, plasma antioxidant status and plasma and urinary concentrations of phytochemical metabolites.
Ethics approval(s)	University of Reading Research Ethics Committee ref: No. 05/06
Health condition(s) or problem(s) studied	Cardiovascular disease
Intervention	Fruit and vegetable puree-based drink (Vie shot, Unilever Bestfoods, Germany) and a sugar-matched fruit-flavoured cordial as the control The intervention food was 400 mL of either flavonoid-rich fruit and vegetable puree-based drink (Apple, Carrot and Strawberry Vie, Unilever Bestfoods) or a low-flavonoid fruit-flavoured sugar-matched control drink. The participants randomly consumed 400 mL one of the drinks on the morning of the study day. They remained in the Human Nutrition Unit for 8 hours post-ingestion and then returned the following morning to return an overnight urine collection and to give a blood sample. After a 4-week washout period they repeated the procedure with the other intervention drink.
Intervention type	Other
Primary outcome measure	1. Vasodilation assessed using laser doppler imaging with iontophoresis 2. Vascular measurements were determined within 2 months of the end of the study
Secondary outcome measures	The antioxidant status was measured by: 1. The ferric reducing antioxidant power (FRAP) assay 2. The oxygen radical absorbance capacity (ORAC) assay 3. By measuring the susceptibility of low density lipoprotein (LDL) to oxidation by a copper catalyst
Overall study start date	01/05/2006
Completion date	20/12/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	25
Key inclusion criteria	1. Healthy individuals 2. Male or female 3. Aged 20-50 years
Key exclusion criteria	1. Suffering from any form of known liver disease, diabetes mellitus or a myocardial infarction 2. Suffering from gall bladder problems or abnormalities of fat metabolism 3. On a weight reducing dietary regimen or taking any dietary supplements, including dietary fatty acids 4. Exercising more than three times a week for more than 20 minutes each session 5. Consuming more than 15 units of alcohol per week
Date of first enrolment	01/05/2006
Date of final enrolment	20/12/2006

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Department of Food and Nutritional Sciences

Reading
RG6 6AP
United Kingdom

Sponsor information

University of Reading (UK)
University/education

Whiteknights
PO Box 217
Reading
RG6 6AP
England
United Kingdom

Website	http://www.reading.ac.uk/
"ROR"	https://ror.org/05v62cm79

Funders

Funder type

University/education

University of Reading Research Endowment Trust Fund (UK)

No information available

Unilever Bestfoods (Germany)

No information available

The Royal Thai Government (Ministry of Science and Technology)

No information available

Chiangmai University (Thailand)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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	01/05/2009		Yes	No