Cholesterol Absorption Inhibition Study (CASTELL)
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|ClinicalTrials.gov Identifier: NCT01138787|
Recruitment Status : Completed
First Posted : June 7, 2010
Last Update Posted : May 4, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Cholesterol Absorption Inhibition||Dietary Supplement: Reference spread Dietary Supplement: Placebo spread Dietary Supplement: Test spread||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||CASTELL = Cholesterol Absorption Study STErols (LL)|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||November 2010|
|Actual Study Completion Date :||November 2010|
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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|