Effects of combining a plant stanol enriched yogurt drink and a low dose statin on markers for inflammation and endothelial function and serum lipoprotein concentrations

ISRCTN	ISRCTN21530271
DOI	https://doi.org/10.1186/ISRCTN21530271
Secondary identifying numbers	NTR389

Submission date: 19/12/2005
Registration date: 19/12/2005
Last edited: 01/09/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

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 J. Plat
Scientific

Maastricht University
Nutrition and Toxicology Research Institute Maastricht (NUTRIM)
Departments of Human Biology
P.O. Box 616
Maastricht
6200 MD
Netherlands

Phone	+31 (0)43 3881309
Email	J.Plat@HB.unimaas.nl

Study information

Study design	Randomised double blind placebo controlled parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Prevention
Scientific title
Study objectives	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(s)	Received from local medical ethics committee
Health condition(s) or problem(s) studied	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
Primary outcome measure	Serum lipid and lipoprotein concentrations.
Secondary outcome measures	Serum markers for endothelial function and low grade systemic inflammation.
Overall study start date	25/01/2005
Completion date	05/08/2005

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	132
Key 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)
Key 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
Date of first enrolment	25/01/2005
Date of final enrolment	05/08/2005

Locations

Countries of recruitment

Netherlands

Study participating centre

Maastricht University

Maastricht
6200 MD
Netherlands

Sponsor information

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

P.O. Box 616
Maastricht
6200 MD
Netherlands

Phone	+31 (0)43 3881476
Email	m.grispen@nutrim.unimaas.nl
"ROR"	https://ror.org/02jz4aj89

Funders

Funder type

Industry

Mc Neil Consumer Nutritionals (Europe)

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