Effect of a tomato sauce (OsteoCol) from vine-ripened tomatoes on lipids

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13244115

Enrollment

108

Registered

2019-05-16

Start date

2018-02-01

Completion date

Unknown

Last updated

2021-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polygenic hypercholesterolemia Nutritional, Metabolic, Endocrine

Interventions

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,

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
LDL-cholesterol according with basal LDL-tertiles measured at baseline and 6 weeks	—

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 24, 2026