Cholesterol Absorption Inhibition Clinical Trial
Official title:
CASTELL = Cholesterol Absorption Study STErols (LL)
Rationale: Consuming Plant Sterols (PS) fortified foods is widely accepted as easy to apply,
life-style change to combat modestly elevated plasma cholesterol concentrations. PS are
typically formulated as PS fatty acid ester (PSE) from margarines. In this study, PS will be
formulated in a new innovative type spread. To confirm that the new spread results in a
comparable cholesterol absorption inhibition as the reference product a dual isotope
cholesterol study is planned, prior to any larger efficacy study.
Primary objective: Cholesterol absorption inhibition (%) calculated from plasma
concentration vs. time curves from labeled cholesterol, for the PS or PSE containing
products, compared to a control product without PS or PSE.
Secondary objectives: PK parameters for cholesterol as derived from the plasma concentration
vs. time curves.
Study design: Acute, single dose, double-blind, randomized, cross-over. Study population: 18
healthy, non-obese men (BMI 20-27 kg∙m-2, age range 20 - 65 yr) Test products: PS (2250 mg)
formulated in innovatively processed spread (30 g); PSE (2250 mg PS) reference product (30
g); Control product without PS or PSE (30 g) Intervention: Three study periods during which
a single dose of either Test, Reference or Control (regular light spread) spreads will be
consumed together with standard breakfast. At each study period, 50 mg of D7-cholesterol is
added to the meal and 30 mg of 13C-cholesterol is injected to measure cholesterol
absorption. Before and four times after consumption of each spread, blood samples will be
taken at 24 h intervals up to 7 days.
Key parameters: Enrichments of labeled cholesterol isotopes as determined by GCMS and IRMS.
Fractional absorption is determined by the ratio of the two isotopes in plasma cholesterol
after 7 days.
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