Condition category
Not Applicable
Date applied
19/12/2005
Date assigned
19/12/2005
Last edited
01/09/2009
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 J. Plat

ORCID ID

Contact details

Maastricht University
Nutrition and Toxicology Research Institute Maastricht (NUTRIM)
Departments of Human Biology
P.O. Box 616
Maastricht
6200 MD
Netherlands
+31 (0)43 3881309
J.Plat@HB.unimaas.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR389

Study information

Scientific title

Acronym

Study hypothesis

Major null hypothesis, H0:
As compared with a plant stanol ester free diet, a stanol ester enriched diet does not change serum concentrations lipids and lipoproteins both when given alone or in combination with a low-dose (10 mg/day) simvastatin
Major alternative hypothesis, Ha:
As compared with a plant stanol ester free diet, a plant stanol ester enriched diet does improve serum concentrations lipids and lipoproteins both when given alone or in combination with a low-dose (10 mg/day) simvastatin

Ethics approval

Received from local medical ethics committee

Study design

Randomised double blind placebo controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

Endothelium, systemic inflammation, lipids, lipoproteins

Intervention

1. Control yogurt drink + placebo tablets
2. Control yogurt drink + simvastatin tablets (10 mg/day)
3. Plant stanol ester yogurt drink + placebo tablets
4. Plant stanol ester yogurt drink + simvastatin tablets (10 mg/day)

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Serum lipid and lipoprotein concentrations.

Secondary outcome measures

Serum markers for endothelial function and low grade systemic inflammation.

Overall trial start date

25/01/2005

Overall trial end date

05/08/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Stable dietary habits
2. Men 55–70 years of age
3. Men 45–54 and women 55-70 years of age with at least one of the following criteria:
3.1. Familial history of coronary heart disease (CHD) in first degree relatives (parent/brother/sister). Only CHD in male relatives below 55 years and in female relatives below 65 years is considered.
3.2. Overweight as defined by body mass index (BMI) >25 (as calculated from weight and length) or abdominal obesity (waist circumference >102 cm for men, >88 cm for women)

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

132

Participant exclusion criteria

1. Smoking
2. Active cardiovascular disease like congestive heart failure or recent (< 6 months) event (acute myocardial infarction, CVA)
3. Peripheral vascular disease
4. Familial hypercholesterolemia
5. Impairment of renal function, as evidenced by increased serum creatinine >150 mmol/l
6. Hepatic diseases as manifested by alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyltransferase (GGT), total bilirubin or alkaline phosphatase (ALP) >2 times the upper limit of normal
7. Severe medical conditions that might interfere with the study such as epilepsy, asthma, chronic obstructive pulmonary disease (COPD), inflammatory bowel diseases, and rheumatoid arthritis
8. Use of medication such as corticosteroids, diuretics or lipid lowering medication including statin use in the prior 2 months
9. Hypersensitivity to simvastatin or any excipient
10. Previous history of muscular toxicity with a statin or fibrate
11. Concomitant use of potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, human immunodeficiency virus [HIV] protease inhibitors, erythromycin, clarithromycin, telithromycin, nefazodone)
12. Unstable body weight (weight gain or loss >3 kg in the past three months)
13. Abnormal hematological profile
14. Abuse of drugs and/or alcohol
15. Pregnant or breastfeeding women
16. Use of sterol or stanol ester products within the previous 30 days
17. Participation in another study within 1 month prior to the screening visit
18. Having donated blood (as blood donor) within 1 month prior to the screening visit or planning to do so during the study

Recruitment start date

25/01/2005

Recruitment end date

05/08/2005

Locations

Countries of recruitment

Netherlands

Trial participating centre

Maastricht University
Maastricht
6200 MD
Netherlands

Sponsor information

Organisation

Nutrition and Toxicology Research Institute Maastricht (NUTRIM) (Netherlands)

Sponsor details

P.O. Box 616
Maastricht
6200 MD
Netherlands
+31 (0)43 3881476
m.grispen@nutrim.unimaas.nl

Sponsor type

Research organisation

Website

Funders

Funder type

Industry

Funder name

Mc Neil Consumer Nutritionals (Europe)

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