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

ISRCTN	ISRCTN14285706
DOI	https://doi.org/10.1186/ISRCTN14285706
Protocol serial number	AGR 17625
Sponsor	Unilever R&D (Netherlands)
Funders	Unilever R&D Vlaardingen BV (Netherlands), Spanish Ministry of Science and Innovation (Instituto de Salud Carlos III [CIBER]) (Spain) - Pathophysiology of Obesity and Nutrition (Fisiopatología de la Obesidad y Nutrición [CIBERobn])

Submission date: 22/09/2010
Registration date: 07/10/2010
Last edited: 07/10/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Emilio Ros
Scientific

Lipid Clinic
Endocrinology & Nutrition Service
Hospital Clínic
C. Villarroel, 170
Barcelona
08036
Spain

Phone	+34 (0)93 2279383
Email	eros@clinic.ub.es

Study information

Primary study design	Interventional
Study design	Randomised crossover feeding intervention study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	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
Study objectives	Plant sterols (PS) are constituents of plants that chemically resemble cholesterol and have cholesterol lowering properties. Traditionally, PS have been incorporated into high-fat foods to facilitate their solubility. Two hypotheses are tested: 1. Compared to a placebo skimmed milk, the consumption of skimmed milk enriched with PS and skimmed plus vegetable fat milk enriched with PS (both low-fat vehicles) will have a hypocholesterolemic effect similar to that of fatty foods fortified with similar doses of PS 2. Baseline serum levels of PS indicative of high intestinal cholesterol absorption will be associated with an enhanced cholesterol-lowering response to consumption of PS
Ethics approval(s)	The Institutional Review Board of the Hospital Clinic of Barcelona approved on the 16th of December 2003 (ref: CEIC 1801)
Health condition(s) or problem(s) studied	Dyslipidemia / Nutrition
Intervention	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 skimmed plus vegetable fat milk with 2 g PS 3. 500 ml/day of placebo skimmed milk Each intervention period will be preceded by a 4-week run-in period with placebo milk.
Intervention type	Other
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	31/10/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	50
Key inclusion criteria	1. Men and women with moderate hypercholesterolemia 2. Aged between 18 and 75 years 3. Body mass index (BMI) <31 kg/m2 4. Serum total cholesterol between 4.91 and 7.75 mmol/L 5. Low Density Lipoprotein (LDL) cholesterol >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.
Key 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
Date of first enrolment	01/02/2004
Date of final enrolment	31/10/2004

Locations

Countries of recruitment

Spain

Study participating centre

Lipid Clinic

Barcelona
08036
Spain

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes