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 5570 years of age
3. Men 4554 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