NCT01138787

Cholesterol Absorption Inhibition Study

CASTELL = Cholesterol Absorption Study STErols (LL)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Unilever R&D · Industry
• Sex: Male
• Age: 20 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Cholesterol Absorption Inhibition

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Reference spread	Single dose (30 gr) of spread, containing 2250 mg PS
DIETARY_SUPPLEMENT	Placebo spread	Single dose (30 gr) of regular light margarine
DIETARY_SUPPLEMENT	Test spread	Single dose (30 gr) of innovatively processed spread containing 2250 mg PS.

Timeline

• Start date: 2010-06-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2010-06-07
• Last updated: 2017-05-04

Locations

1 site across 1 country: Netherlands