mild hypercholesterolemia slightly elevated cholesterol
Conditions
Interventions
Three study periods during which a single dose of either Test, Reference or
Control (regular Becel light) spreads will be consumed together with standard
breakfast. At each study period, 50 mg of D7
Sponsors
Unilever
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Apparently healthy males aged 20 - 65 y - BMI 20-27 kg/m2 - LDL-C levels between 3.0 * 5.0 mmol/L, triglycerides
Exclusion criteria
Exclusion criteria: - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Enrichments of labeled cholesterol isotopes as determined by GCMS and IRMS in plasma. Fractional absorption is determined by the ratio of the two isotopes in plasma cholesterol over 7 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| PK parameters (for labeled cholesterol) derived from plasma curves (Cmax, Tmax, cholesterol pool, flux). | — |
Countries
Netherlands
Outcome results
None listed