Effect of milk fortified with plant sterols on the lipid profile of patients with moderate hypercholesterolemia

Effect of milk fortified with plant sterols on the lipid profile and serum non-cholesterol sterols of patients with moderate hypercholesterolemia: A randomised, crossover feeding study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14285706

Enrollment

Registered

2010-10-07

Start date

2004-02-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Dyslipidemia / Nutrition Nutritional, Metabolic, Endocrine Disorders of lipoprotein metabolism and other lipidaemias

Interventions

All subjects will participate in each of 3 intervention periods lasting 4 weeks each. The sequence of the interventions will be randomised: 1. 500 ml/day of skimmed milk with 2 g PS 2. 500 ml/day of

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Men and women with moderate hypercholesterolemia 2. Aged between 18 and 75 years 3. Body mass index (BMI) 3.36 mmol/L 6. Triglycerides <3.39 mmol/L 7. Participants can be under stable lipid-lowering drug treatment (statins or fibrates, statins at doses of no more than simvastatin 40 mg/day or equivalent) or cardiac medication in patients with previous cardiovascular disease 8. Written informed consent. Participants were given a leaflet with explanation of the study, including reasons for masking the contents of the milk product, and information on how to contact investigators if necessary.

Exclusion criteria

Exclusion criteria: 1. Subjects on a weight-losing diet 2. Familial hypercholesterolemia 3. Established type 2 diabetes 4. Lactose intolerance 5. Consumption of products that can influence cholesterol metabolism (other than statins and fibrates), such as 5.1. resins 5.2. ezetimibe 5.3. psyllium products 5.4. fish oil products 5.5. soya lecithin 5.6 phytoestrogens

Design outcomes

Primary

Measure	Time frame
1. Effects on the serum lipid profile 2. Effects on serum non-cholesterol sterol concentrations 2.1. demosterol 2.2. lathosterol 2.3. lanosterol 2.4. campesterol 2.5. sitosterol Measurements are taken at baseline, after the run-in period, and at the end of the three 4-week diet intervention periods.	—

Secondary

Measure	Time frame
Influence of baseline serum non-cholesterol concentrations and their on-treatment changes on the cholesterol-lowering response Measurements are taken at the same time points than primary outcome measures.	—

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026