Condition category
Nutritional, Metabolic, Endocrine
Date applied
22/09/2010
Date assigned
07/10/2010
Last edited
07/10/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Emilio Ros

ORCID ID

Contact details

Lipid Clinic
Endocrinology & Nutrition Service
Hospital Clínic
C. Villarroel
170
Barcelona
08036
Spain
+34 (0)93 2279383
eros@clinic.ub.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

AGR 17625

Study information

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

Acronym

Study hypothesis

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

The Institutional Review Board of the Hospital Clinic of Barcelona approved on the 16th of December 2003 (ref: CEIC 1801)

Study design

Randomised crossover feeding intervention study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/02/2004

Overall trial end date

31/10/2004

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant 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

Recruitment start date

01/02/2004

Recruitment end date

31/10/2004

Locations

Countries of recruitment

Spain

Trial participating centre

Lipid Clinic
Barcelona
08036
Spain

Sponsor information

Organisation

Unilever R&D (Netherlands)

Sponsor details

c/o Dr. Elke A. Trautwein
Olivier van Noortlaan 120. PO Box 114
Vlaardingen
3130AC
Netherlands

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Unilever R&D Vlaardingen BV (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

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])

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes