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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.


- candidate number1624
- NTR NumberNTR389
- ISRCTNISRCTN21530271
- Date ISRCTN created19-dec-2005
- date ISRCTN requested28-okt-2005
- Date Registered NTR13-sep-2005
- Secondary IDsN/A 
- Public TitleEffects of combining a plant stanol enriched yogurt drink and a low dose statin on markers for inflammation and endothelial function and serum lipoprotein concentrations.
- Scientific TitleEffects of combining a plant stanol enriched yogurt drink and a low dose statin on markers for inflammation and endothelial function and serum lipoprotein concentrations.
- ACRONYMN/A
- hypothesisMajor null hypotheses, 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 hypotheses, 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.
- Healt Condition(s) or Problem(s) studiedSystemic inflammation
- Inclusion criteria1. Stable dietary habits;
2. Men 55 70 years of age;
3. Men 45 54 and women over 55 -70 years of age with at least one of the following criteria :
a. 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;
b. Overweight as defined by BMI >25 (as calculated from weight and length) or abdominal obesity (waist circumference >102 cm for men, >88 cm for women).
- Exclusion criteria1. 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 ALT, AST, GGT, total billirubin or ALP > 2 times the upper limit of normal;
7. Severe medical conditions that might interfere with the study such as epilepsy, asthma, 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 (eg itraconazole, ketoconazole, 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 25-jan-2005
- planned closingdate5-aug-2005
- Target number of participants132
- Interventions1. 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).
- Primary outcomeSerum lipid and lipoprotein concentrations.
- Secondary outcomeSerum markers for endothelial function and low grade systemic inflammation.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESPhD. J. Plat
- CONTACT for SCIENTIFIC QUERIESPhD. J. Plat
- Sponsor/Initiator Nutrition and Toxicology Research Institute Maastricht (NUTRIM)
- Funding
(Source(s) of Monetary or Material Support)
Mc Neil Consumer Nutritionals Europe
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD13-sep-2005 - 5-sep-2008


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