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
2. Prof. Arturo Pujia
Prof Tiziana Montalcini
viale S .Venuta Università Magna Grecia
Prof Arturo Pujia
viale S. Venuta
Effect of a novel functional tomato sauce (OsteoCol) from vine-ripened tomatoes on serum lipids in individuals with common hypercholesterolemia
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.
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: email@example.com; firstname.lastname@example.org), ref: 06/2018/CE
Randomized cross-over study
Primary study design
Secondary study design
Randomised cross over trial
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
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.
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
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
1. Individuals with polygenic hypercholesterolemia
2. Both genders
3. Aged over 40 years
4. Not taking medications or supplements
Target number of participants
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
Recruitment end date
Countries of recruitment
Trial participating centre
University Magna Grecia
viale S. Venuta
University Magna Grecia Catanzaro
Funding Body Type
Funding Body Subtype
Italian Society for the Study of Atherosclerosis (SISA)
Funding Body Type
Funding Body Subtype
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 (email@example.com).
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
Participant level data
Available on request
Basic results (scientific)