Condition category
Circulatory System
Date applied
10/03/2011
Date assigned
01/07/2011
Last edited
19/05/2014
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 Julie Lovegrove

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

Acronym

FlaKS

Study hypothesis

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

University of Reading Research Ethics Committee ref: No. 05/06

Study design

Randomised controlled single-blind intervention study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Screening

Patient information sheet

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

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/05/2006

Overall trial end date

20/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy individuals
2. Male or female
3. Aged 20-50 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

25

Participant 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

Recruitment start date

01/05/2006

Recruitment end date

20/12/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

University of Reading (UK)

Sponsor details

Whiteknights
PO Box 217
Reading
RG6 6AP
United Kingdom

Sponsor type

University/education

Website

http://www.reading.ac.uk/

Funders

Funder type

University/education

Funder name

University of Reading Research Endowment Trust Fund (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Unilever Bestfoods (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Royal Thai Government (Ministry of Science and Technology)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Chiangmai University (Thailand)

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

2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/19288973

Publication citations

  1. Results

    George TW, Niwat C, Waroonphan S, Gordon MH, Lovegrove JA, Effects of chronic and acute consumption of fruit- and vegetable-puree-based drinks on vasodilation, risk factors for CVD and the response as a result of the eNOS G298T polymorphism., Proc Nutr Soc, 2009, 68, 2, 148-161, doi: 10.1017/S0029665109001165.

Additional files

Editorial Notes