Cholesterol Absorption Inhibition Study in humans after single intake of cholesterol lowering margarine, Unilever Study 09030-V, Study name: CASTE
- Conditions
- mild hypercholesterolemiaslightly elevated cholesterol10013317
- Registration Number
- NL-OMON34622
- Lead Sponsor
- nilever
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 18
- Apparently healthy males aged 20 - 65 y
- BMI 20-27 kg/m2
- LDL-C levels between 3.0 * 5.0 mmol/L, triglycerides < 3.0 mmol/L
- Non-smoker (tobacco, marijuana).
- No use of medication which interferes with study measurements
- Consumption <=< 21 alcoholic drinks in a typical week.
- No reported participation in another nutritional or biomedical trial 3 months before the pre-study examination or during the study.
- No reported participation in night shift work during the study.
- Unwilling to refrain from consumption of plant sterol or stanol containing products, e.g. Becel pro.activ, Benecol, etc one week before and during the study
- Plasma lipid profile which indicates deviating lipid / cholesterol homeostasis
- Evidence of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/ immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/ connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological/ psychiatric diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol.
- Gastrointestinal or hepatic disorders influencing gastrointestinal absorption or transit, including gallstones or biliary diseases.
- History of surgery related to the gastro-intestinal tract
- On a medically prescribed or weight reduction diet
- Recreational (intravenous) drug use.
- The use of psychotropic drugs, including: benzodiazepines or alcohol in excess of 21 units/ week for males
- Concomitant medication that may modulate gastro-intestinal secretions and pH (e.g. antacids, proton-pump-inhibitors, prostaglandins, anticholinergic agents, H2-receptor antagonists)
- Concomitant medication that can alter gastric emptying (e.g. metoclopramide, cisapride, domperidone and erythromycin, anticholinergics, tricyclic antidepressants, narcotic analgesics, adrenergic agents, calcium channel blockers)
- Concomitant medication that can alter intestinal transit (e.g. loperamide, chemical/ osmotic/bulk laxatives), or influence satiety/energy intake (e.g. sibutramine, glucocorticoids, anabolic steroids)
- Intolerance or allergy for test product.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Enrichments of labeled cholesterol isotopes as determined by GCMS and IRMS in<br /><br>plasma. Fractional absorption is determined by the ratio of the two isotopes in<br /><br>plasma cholesterol over 7 days.</p><br>
- Secondary Outcome Measures
Name Time Method <p>PK parameters (for labeled cholesterol) derived from plasma curves (Cmax, Tmax,<br /><br>cholesterol pool, flux).</p><br>