Cholesterol Absorption Inhibition Study (CASTELL)
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.
|Cholesterol Absorption Inhibition||Dietary Supplement: Reference spread Dietary Supplement: Placebo spread Dietary Supplement: Test spread|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Participant, Investigator, Outcomes Assessor
Primary Purpose: Prevention
|Official Title:||CASTELL = Cholesterol Absorption Study STErols (LL)|
- cholesterol absorption calculated from plasma cholesterol enrichments vs. time curves [ Time Frame: 5 blood samples within one week for each intervention ]
- PK parameters derived from plasma curves (Cmax, Tmax, cholesterol pool, flux). [ Time Frame: 5 blood samples within one week for each intervention ]
|Study Start Date:||June 2010|
|Study Completion Date:||November 2010|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
Active Comparator: Reference spread
2250 mg PS (as PSE) in spread (30 g)
Dietary Supplement: Reference spread
Single dose (30 gr) of spread, containing 2250 mg PS
Placebo Comparator: Placebo spread
regular light margarine (30 g)
Dietary Supplement: Placebo spread
Single dose (30 gr) of regular light margarine
Experimental: Test spread
2250 mg PS in innovatively processed spread (30 g)
Dietary Supplement: Test spread
Single dose (30 gr) of innovatively processed spread containing 2250 mg PS.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01138787
|Academisch Medisch Centrum, vasculaire geneeskunde|
|Amsterdam, Noord-Holland, Netherlands|
|Principal Investigator:||Maud N Vissers, Dr. Ir||Academisch Medisch Centrum, afdeling vasculaire geneeskunde|
|Study Director:||Guus SM Duchateau, Dr||Unilever Research & Development Vlaardingen|