Effect of a tomato sauce (OsteoCol) from vine-ripened tomatoes on lipids
| ISRCTN | ISRCTN13244115 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13244115 |
| Secondary identifying numbers | 06/2018/CE |
- Submission date
- 14/05/2019
- Registration date
- 16/05/2019
- Last edited
- 12/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
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
Contact information
Scientific
viale S .Venuta Università Magna Grecia
Catanzaro
88100
Italy
| Phone | +39 (0)3316718386 |
|---|---|
| tmontalcini@unicz.it |
Scientific
viale S. Venuta
Catanzaro
88100
Italy
| Phone | +39 (0)3316718206 |
|---|---|
| pujia@unicz.it |
Study information
| Study design | Randomized cross-over study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Effect of a novel functional tomato sauce (OsteoCol) from vine-ripened tomatoes on serum lipids in individuals with common hypercholesterolemia |
| Study 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(s) | 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 |
| 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 |
| 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 study start date | 01/09/2017 |
| Overall study end date | 30/05/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 108 |
| Total final enrolment | 108 |
| Participant inclusion criteria | 1. Individuals with polygenic hypercholesterolemia 2. Both genders 3. Aged over 40 years 4. Not taking medications or supplements |
| 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 | 09/05/2018 |
Locations
Countries of recruitment
- Italy
Study participating centre
Catanzaro
88100
Italy
Sponsor information
University/education
Clinical Nutrition Unit
viale S. Venuta
95/1
Catanzaro
88100
Italy
| Phone | +39 (0)3316718206 |
|---|---|
| pujia@unicz.it | |
| Website | https://web.unicz.it/it/ |
"ROR" |
https://ror.org/0530bdk91 |
Funders
Funder type
University/education
No information available
No information available
Results and Publications
| Intention to publish date | 30/06/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 06/01/2021 | 12/01/2021 | Yes | No |
Editorial Notes
12/01/2021: Publication reference added.
15/08/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/07/2019 to 09/05/2018.
2. The total final enrolment number was added.
15/05/2019: Trial's existence confirmed by local ethics committee.
