Cholesterol Absorption Inhibition Study

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

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.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  collaborator OTHER

• Unilever R&D

  lead INDUSTRY

Principal Investigators

• Maud N Vissers, Dr. Ir · Academisch Medisch Centrum, afdeling vasculaire geneeskunde

• Guus SM Duchateau, Dr · Unilever Research & Development Vlaardingen

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

20 Years

Max Age

65 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-06-30

Primary Completion

2010-11-30

Completion

2010-11-30

Countries

• Netherlands

Study Locations