Milk products supplemented with Phytosterols or omega-3 oils and biomarkers of cardiovascular disease

Scientific basis of cardiovascular effects derived from the regular consumption of milk products supplemented with Phytosterols or omega-3 oils at systemic level in subjects at low cardiovascular risk with moderated hypercholesterolemia and overweight or obesity.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN78753338

Enrollment

Registered

2017-03-16

Start date

2012-02-15

Completion date

Unknown

Last updated

2025-09-08

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

Conditions

Arteriosclerosis Circulatory System Atherosclerosis

Interventions

All subjects were submitted to two 28-day treatment sequences, separated by a 4 weeks washout period. Before the initiation of the intervention, individuals were submitted to a 2-week run-in period. D

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Healthy adult males and females between 25 and 70 years old 2. Overweight or grade 1 obese (body mass index greater than 25 kg/m^2) 3. Signed informed consent

Exclusion criteria

Exclusion criteria: 1. Previous history of cardiovascular disease (ischaemic heart disease - angina or recent or old myocardial infarction, cerebral vascular accident, or peripheral vascular disease) 2. No documented cardiovascular disease (ischaemic heart disease - angina or recent or old myocardial infarction or previous or cerebral vascular accident, peripheral vascular disease) 3. Any disease affecting lipid metabolism 4. Any severe chronic disease 5. Lactose intolerance 6. Being in the phase of weight loss or expressing a desire for weight loss in the 4 months of the study 3. Alcohol consumption >60 g/day 7. Under treatment with fibrates or statins

Design outcomes

Primary

Measure	Time frame
1. Triglyceride and cholesterol levels, measured using biochemical analysis 2. Oxidative profile: measure of the lipidic peroxidation in plasma and LDL, the plasma antioxidant behavior and LDL resistance to oxidation 3. Fatty acids (FA) and lipidomic pattern measured in plasma and LDL samples respectively and analyzed by LC/MS/MS. The analysis of FA is performed after the derivatization of the samples to convert FAs into thrimethylaminoethyl esther iodide derivates. LDL lipidomic profile is analyzed in mixture with an internal lipid standard mixture 4. Proteomic profile: 4.1. Analysis of the differential proteomic profile of the lipid and lipid-free fraction of serum and plasma samples measured by 2DE electrophoresis, followed by protein identification by mass spectrometry identification (MALDI-TOF) 4.2. Validation of the results by western blot analysis and enzyme-linked immunosorbent assay (ELISA) kits Measured at baseline and after each intervention period	—

Measure

Time frame

1. Triglyceride and cholesterol levels, measured using biochemical analysis 2. Oxidative profile: measure of the lipidic peroxidation in plasma and LDL, the plasma antioxidant behavior and LDL resistance to oxidation 3. Fatty acids (FA) and lipidomic pattern measured in plasma and LDL samples respectively and analyzed by LC/MS/MS. The analysis of FA is performed after the derivatization of the samples to convert FAs into thrimethylaminoethyl esther iodide derivates. LDL lipidomic profile is analyzed in mixture with an internal lipid standard mixture 4. Proteomic profile: 4.1. Analysis of the differential proteomic profile of the lipid and lipid-free fraction of serum and plasma samples measured by 2DE electrophoresis, followed by protein identification by mass spectrometry identification (MALDI-TOF) 4.2. Validation of the results by western blot analysis and enzyme-linked immunosorbent assay (ELISA) kits Measured at baseline and after each intervention period

—

Secondary

Measure	Time frame
1. Alcohol intake, smoking and dietary habits, taken from participants' medical records 2. Dietary habits, assessed using a questionnaire at baseline 3. Inflammatory variables related to atherosclerosis 4. Gene expression measured by RT-PCR and arrays either in the plasma or the blood cellular fraction after the intake of supplemented milk 5. Circulating microparticles assessed using blood samples or the cells of the vascular wall 6. Potential gene polymorphisms associated with the response to the interventions at protemic and lipidomic levels Measured at baseline and after each intervention period	—

Measure

Time frame

1. Alcohol intake, smoking and dietary habits, taken from participants' medical records 2. Dietary habits, assessed using a questionnaire at baseline 3. Inflammatory variables related to atherosclerosis 4. Gene expression measured by RT-PCR and arrays either in the plasma or the blood cellular fraction after the intake of supplemented milk 5. Circulating microparticles assessed using blood samples or the cells of the vascular wall 6. Potential gene polymorphisms associated with the response to the interventions at protemic and lipidomic levels Measured at baseline and after each intervention period

—

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 26, 2026