Condition category
Nutritional, Metabolic, Endocrine
Date applied
14/05/2019
Date assigned
16/05/2019
Last edited
16/05/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Intake of a tomato sauce with a high carotenoid (antioxidant) content in association with other lifestyle interventions may be a treatment for patients affected by common hypercholesterolemia (high blood cholesterol). Most studies focused on the benefits of lycopene, an antioxidant contained in tomato, on serum lipids but no studies have been specifically designed to assess the role of a tomato sauce from vine-ripened tomatoes (thus, naturally high in carotenoids) on patients affected by common hypercholesterolemia. The aim of this study is to investigate the effects of a tomato sauce from vine-ripened tomatoes on lipids and compare the effects with a well-known commercialized functional food with a lipid-lowering effect, a sterol-enriched yoghurt.

Who can participate?
Patients aged over 40 with polygenic hypercholesterolemia who are not taking medications or supplements

What does the study involve?
Participants are randomly allocated to consume either a functional tomato sauce or a sterol-enriched yoghurt every day for 6 weeks. Participants also receive oral and written recommendations to adhere to a Mediterranean dietary pattern, without energy restriction.

What are the possible benefits and risks of participating?
Participants receive continuous clinical support as well as cholesterol reduction with safe and natural methods. There are no risks of participating in the study because tomato sauce is obtained with natural methods and the yoghurt with sterols is already commercialised. If cholesterol increases, appropriate drugs are prescribed.

Where is the study run from?
University Magna Grecia (Italy)

When is the study starting and how long is it expected to run for?
September 2017 to May 2020

Who is funding the study?
1. University Magna Grecia Catanzaro (Italy)
2. Italian Society for the Study of Atherosclerosis (SISA) (Italy)

Who is the main contact?
1. Prof. Tiziana Montalcini
tmontalcini@unicz.it
2. Prof. Arturo Pujia
pujia@unicz.it

Trial website

Contact information

Type

Scientific

Primary contact

Prof Tiziana Montalcini

ORCID ID

Contact details

viale S .Venuta Università Magna Grecia
Catanzaro
88100
Italy
+39 (0)3316718386
tmontalcini@unicz.it

Type

Scientific

Additional contact

Prof Arturo Pujia

ORCID ID

Contact details

viale S. Venuta
Catanzaro
88100
Italy
+39 (0)3316718206
pujia@unicz.it

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

06/2018/CE

Study information

Scientific title

Effect of a novel functional tomato sauce (OsteoCol) from vine-ripened tomatoes on serum lipids in individuals with common hypercholesterolemia

Acronym

OsteoCol

Study hypothesis

Most studies focused on the benefits of lycopene on serum lipids but no studies have been specifically designed to assess the role of a tomato sauce from vine-ripened tomatoes on patients affected by polygenic hypercholesterolemia. This study will compare the lipid-lowering effect of this functional tomato sauce with a well-known commercialized functional food with a lipid-lowering effect, i.e. a sterol-enriched yoghurt.

Ethics approval

Approved 18/01/2018, local ethical committee at the “Mater Domini” Azienda University Hospital (viale T. Campanella, Catanzaro, Italy; Tel: +39 (0)961 712 111; Email: comitatoetico@hot.mail.it; michelangelo.rossano@regione.calabria.it), ref: 06/2018/CE

Study design

Randomized cross-over study

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Polygenic hypercholesterolemia

Intervention

Participants are randomised by simple randomization to:
1. A functional tomato sauce [namely OsteCol (registered Patent), from tomatoes ripened on-the-vine], 150 ml/day (by C.G. Food, SRL, Soverato, Italy)
2. A sterol-enriched yoghurt (100 g/die of Danacol, containing sterols 1.6 g/die, by Danone, SPA, Milano, Italy).

Participants will receive oral and written recommendations to adhere to a Mediterranean dietary pattern, without energy restriction. Macronutrient distribution as a percentage of total energy range from 50% to 55% carbohydrate, 15% to 20% protein and 20% to 35% fat, with a recommended protein intake of 1 g/kg of ideal body weight. Duration: 6 weeks.

Intervention type

Other

Phase

Drug names

Primary outcome measure

1. Total cholesterol measured by chemiluminescent immunoassay on COBAS 8000 (Roche, Switzerland), according to the manufacturer’s instructions at baseline and 6 weeks
2. LDL-cholesterol calculated by the Friedewald formula at baseline and 6 weeks

Secondary outcome measures

LDL-cholesterol according with basal LDL-tertiles measured at baseline and 6 weeks

Overall trial start date

01/09/2017

Overall trial end date

30/05/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Individuals with polygenic hypercholesterolemia
2. Both genders
3. Aged over 40 years
4. Not taking medications or supplements

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

108

Participant exclusion criteria

1. Familial hypercholesterolemia
2. Triglycerides concentration over 200 mg/dl
3. Secondary causes of hyperlipidemia
4. Debilitating diseases, as ascertained

Recruitment start date

01/02/2018

Recruitment end date

30/07/2019

Locations

Countries of recruitment

Italy

Trial participating centre

University Magna Grecia
viale S. Venuta
Catanzaro
88100
Italy

Sponsor information

Organisation

University Magna Grecia Catanzaro

Sponsor details

Clinical Nutrition Unit
viale S. Venuta
95/1
Catanzaro
88100
Italy
+39 (0)3316718206
pujia@unicz.it

Sponsor type

University/education

Website

https://web.unicz.it/it/

Funders

Funder type

University/education

Funder name

University Magna Grecia Catanzaro

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Italian Society for the Study of Atherosclerosis (SISA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The researchers will submit results in 2019/20 to scientific journals with an impact factor as well as popular magazines.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Tiziana Montalcini (tmontalcini@unicz.it).
Type of data: Excel file.
When the data will become available: 30/05/2020.
For how long: currently not known.
Access criteria data will be shared including with whom, for what types of analyses: descriptive analysis of the population.
The researchers need to guarantee data anonymisation, all requests will be approved by the Principal Investigator.

Intention to publish date

30/06/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

15/05/2019: Trial's existence confirmed by local ethics committee.