Condition category
Not Applicable
Date applied
28/04/2016
Date assigned
29/04/2016
Last edited
29/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
In recent years, there has been considerable interest in the use of natural food components as functional foods to treat high blood pressure (hypertension), especially for people with borderline to mild high blood pressure that does not warrant the prescription of anti-hypertensive drugs. Over the last 15 years we have studied a tomato extract that is now marketed as Fruitflow. We do not know how much Fruitflow should be consumed in order to have a reasonable blood pressure lowering effect in moderately hypertensive people. We therefore want to examine the effects of consuming Fruitflow on blood pressure in a small group of healthy people.

Who can participate?
Healthy male volunteers, over 35 years of age, with no history of cardiovascular (heart) disorders but with some elevated risk factors and resting blood pressure above 135/90

What does the study involve?
Participants are randomly allocated to consume either one of two doses of Fruitflow or a placebo (dummy) supplement. Their blood pressure is then assessed every hour for 24 hours. Blood samples are also taken. Each participant undergoes all three interventions.

What are the possible benefits and risks of participating?
Participants will receive insights into their 24-hour blood pressure patterns, and will be compensated for loss of time. There are no other direct benefits. The risks involved with participation relate to the risks associated with blood sampling, which are minimised by strict adherence to standard protocols. The supplement is a food product which can be obtained in several forms in supermarkets or over the counter in pharmacies. No specific risks are associated with this supplement.

Where is the study run from?
University of Oslo (Norway)

When is the study starting and how long is it expected to run for?
March to June 2016

Who is funding the study?
Provexis (UK)

Who is the main contact?
Prof Asim Duttaroy
a.k.duttaroy@medisin.uio.no

Trial website

Contact information

Type

Public

Primary contact

Prof Asim Duttaroy

ORCID ID

http://orcid.org/0000-0003-1619-3778

Contact details

Dept of Nutrition
IMB
Faculty of Medicine
University of Oslo
Oslo
0316
Norway
+47 (0)22851547
a.k.duttaroy@medisin.uio.no

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

690391

Study information

Scientific title

Blood pressure lowering effect of Fruitflow® (tomato extract)

Acronym

Study hypothesis

We will examine the effects of consuming Fruitflow® (150 mg and 300 mg) on blood pressure after 24h in a small group of healthy subjects (n=12).

In order to test the physiological relevance of the observed effects of Fruitflow® on ACE, some initial work is required to set basic parameters. This work divides into two main phases. The first is to allow some estimate of likely dosage ranges. This information would be useful to indicate whether the primary use of this agent for lowering ACE activity is likely to be medicinal or whether it can be used as a functional food ingredient.

Ethics approval

Regionale Komiter for Medisinsk og Helsefaglig Forskningsetikk (REK), ref no: 2015/396/REK sør-øst C

Study design

Randomised cross over trial

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Schools

Trial type

Other

Patient information sheet

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

Condition

Not Applicable

Intervention

For the initial pilot tests, 12 subjects will be selected to form a homogenous investigation group. A crossover design will be employed. Two intervention doses will be tested (150 mg and 300 mg Fruitflow) and compared to placebo. Thus each subject will undergo three interventions. In addition, subjects will undergo a screening procedure in advance of the interventions in which ambulatory blood pressure will be assessed.

Intervention type

Supplement

Phase

Drug names

Primary outcome measures

Ambulatory blood pressure monitoring over a 24-hour period will be used as the main outcome measure. Protocol to be confirmed. Static blood pressure measurements may also be carried out at convenient intervals. The primary end point is change in mean systolic blood pressure (mmHg) between baseline and each follow up point.

Secondary outcome measures

1. Change in mean diastolic blood pressure between baseline and each follow up point
2. Plasma ACE assessed at to and at t3 hours after consumption of supplements
3. Platelet response assessed at to and at t3 hours after consumption of supplements

Overall trial start date

01/03/2016

Overall trial end date

10/06/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male subjects
2. No history of cardiovascular disorders but with some elevated risk factors
3. Over 35 years of age
4. Resting blood pressure above 135/90
5. Normal blood level ACE activity
6. Normal platelet aggregation response against ADP
7. Should not take any blood pressure medications and platelet-modulating drugs for at least 2 weeks

Participant type

Healthy volunteer

Age group

Adult

Gender

Male

Target number of participants

15

Participant exclusion criteria

Does not fulfill inclusion criteria

Recruitment start date

05/03/2016

Recruitment end date

10/06/2016

Locations

Countries of recruitment

Norway

Trial participating centre

University of Oslo
Dept of Nutrition IMB Faculty of Medicine
Oslo
0316
Norway

Sponsor information

Organisation

Provexis (UK)

Sponsor details

58 Queens Road
Reading
RG1 4RP
United Kingdom

Sponsor type

Industry

Website

http://provexis.org

Organisation

Inven2 (Norway)

Sponsor details

Gaustadalléen 21
Oslo
0349
Norway
+47 (0)22 84 00 80
post@inven2.com

Sponsor type

Industry

Website

http://www.inven2.com/no

Funders

Funder type

Industry

Funder name

Provexis (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes