Investigating whether different doses of Fruitflow have equal impact on blood platelets in different healthy subjects
| ISRCTN | ISRCTN53447583 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53447583 |
| Secondary identifying numbers | FF pilot 01 |
- Submission date
- 16/02/2021
- Registration date
- 24/02/2021
- Last edited
- 31/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
For many years there has been an interest in the possible benefit to public health from the use of natural food components in preventing chronic illnesses such as cardiovascular diseases. One such natural food ingredient which has been much studied is a tomato extract now marketed as Fruitflow. Fruitflow is a natural antiplatelet (preventing blood clots from forming).
This study plans to investigate whether, due to differences in platelets in the normal population, different doses of Fruitflow may lead to similar responses, in different individuals. This would help to determine whether personalised doses of Fruitflow should be recommended. The study will test how effective each dose of Fruitflow is, and whether it would be possible and appropriate to carry out a larger trial with more participants at a later stage.
Who can participate?
Healthy male subjects aged over 30 years, without a history of cardiovascular disease, and who are not currently taking supplements or medications known to affect platelet function.
What does the study involve?
The study will involve a screening visit, in which suitability for inclusion is assessed, followed by a total of five trips to the University of Oslo Faculty of Medicine. At each of these visits, a blood sample will be taken, after which, one of five different doses of the Fruitflow supplement will be consumed. Neither the subject nor the study investigators will know the dosage administered at each visit. Breakfast will be offered after the supplement and then the next morning, 24 h after taking the supplement, a second blood sample will be taken. Subjects will then have a break of 10 to 14 days before the next visit. This will be repeated for the five different doses of Fruitflow so that the effects of different doses on each individual participant can be examined.
What are the possible benefits and risks of participating?
There will be no direct benefits to participants, but they will be compensated for travel costs and loss of time.
No specific risks are associated with the supplement. The risks involved in participation relate to the risks associated with blood sampling, which will be minimised by strict adherence to standard protocols. The supplement is a food ingredient that is currently consumed in many countries worldwide and can be obtained in supermarkets, health food shops, and pharmacies.
Where is the study run from?
The Medical Faculty of the University of Oslo (Norway)
When is the study starting and how long is it expected to run for?
From December 2018 to June 2019
Who is funding the study?
DSM Nutrition Ltd (Switzerland)
Who is the main contact?
Professor Asim Duttaroy, a.k.duttaroy@medisin.uio.no
Contact information
Scientific
Dept of Nutrition
IMB
Faculty of Medicine
University of Oslo
Oslo
O316
Norway
 ORCID ID |
0000-0003-1619-3778 |
|---|---|
| Phone | +47(0)22851547 |
| a.k.duttaroy@medisin.uio.no |
Study information
| Study design | Double-blinded randomized cross-over pilot study with 5 masked interventions |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Evaluation of the equivalence of different doses of Fruitflow® in affecting blood platelet aggregation and thrombin generation capacity in a pilot study in healthy subjects |
| Study hypothesis | Due to the inherent heterogeneity in platelet response between individuals, different doses of a tomato extract known as Fruitflow (0, 30, 75, and 300 mg) may be equivalent to the standard daily dose of 150mg within individuals. |
| Ethics approval(s) | Approved 19/12/2017, Regionale Komiteer for Medisinsk og Helsefaglig Forskningsetikk (REK) sør-Øst (Gullhaugveien 1-3, 0484 Oslo, Norway; +47 22845515; post@helseforskning.etikkom.no), ref: 20157396/REK/Sør-Øst |
| Condition | Reduction of platelet hyperactivity in healthy subjects |
| Intervention | The study sets out to examine whether 5 different doses of Fruitflow (0, 30, 75, and 300 mg) are equivalent to the standard daily dose of 150mg. The study will follow a double-blind randomised crossover design, in which five masked interventions will be administered to each subject, with interventions separated by a minimum of 10 days. |
| Intervention type | Supplement |
| Primary outcome measure | Platelet aggregation in response to optimised adenosine diphosphate (ADP) agonist concentration, measured using light transmission aggregometry at baseline and 24 h |
| Secondary outcome measures | Thrombin generation capacity measured by fluorogenic substrate generation at baseline and 24 h |
| Overall study start date | 01/01/2018 |
| Overall study end date | 30/06/2020 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 10-12 |
| Total final enrolment | 10 |
| Participant inclusion criteria | 1. Male subjects 2. No history of cardiovascular disease 3. Aged ≥30 years 4. Normal haemostatic measurements 5. Normal platelet aggregation response to adenosine diphosphate (ADP) agonist 6. Not taking any supplements or medications known to affect platelet function, without a suitable washout period |
| Participant exclusion criteria | Does not meet inclusion criteria |
| Recruitment start date | 01/05/2018 |
| Recruitment end date | 31/12/2018 |
Locations
Countries of recruitment
- Norway
Study participating centre
IMB Faculty of Medicine
Oslo
O316
Norway
Sponsor information
Industry
DSM Nutritional Products Ltd
Wurmisweg 576
Kaiseraugst
CH-4303
Switzerland
| Phone | +41618158888 |
|---|---|
| a.k.duttoroy@uio.medisin.no | |
| Website | https://www.dsm.com/corporate/about/businesses/dsm-nutritional-products.html |
"ROR" |
https://ror.org/01fgq8278 |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- DSM Research BV
- Location
- Netherlands
Results and Publications
| Intention to publish date | 30/06/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. Study data analysis will complete during 2020 and thus publication is planned for between late 2020 and early 2021. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to commercial confidentiality. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 06/12/2021 | 31/10/2022 | Yes | No |
Editorial Notes
31/10/2022: Publication reference added.
24/02/2021: Trial’s existence confirmed by DSM Nutritional Products Ltd.
