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 |
| Secondary identifying numbers | AGR 17625 |
- 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
Scientific
Lipid Clinic
Endocrinology & Nutrition Service
Hospital Clínic
C. Villarroel, 170
Barcelona
08036
Spain
| Phone | +34 (0)93 2279383 |
|---|---|
| eros@clinic.ub.es |
Study information
| Study design | Randomised crossover feeding intervention study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details below to request a patient 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 | 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 outcome measures | 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. |
| Overall study start date | 01/02/2004 |
| Completion date | 31/10/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
08036
Spain
Sponsor information
Unilever R&D (Netherlands)
Industry
Industry
c/o Dr. Elke A. Trautwein
Olivier van Noortlaan 120. PO Box 114
Vlaardingen
3130AC
Netherlands
"ROR" |
https://ror.org/02436cs38 |
|---|
Funders
Funder type
Industry
Unilever R&D Vlaardingen BV (Netherlands)
No information available
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])
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
