Rye Bread Trial; Antioxidative and Cholesterol Lowering Effects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2010-02-28

Brief Summary

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The purpose of this study is to investigate the antioxidative effects of alkylresorcinols (AR), originating from the rye fiber, on serum LDL particles and the use of AR or it's metabolites as biomarkers for rye fiber intake and the effect of additional plants sterols, incorporated in the rye bread, on serum total and LDL cholesterol concentration.

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Detailed Description

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Conditions

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Hypercholesterol

Study Design

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Intervention Model

PARALLEL

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Sterol

Additional plant sterols incorporated in the rye bread

Group Type ACTIVE_COMPARATOR

Rye-2008

Intervention Type DIETARY_SUPPLEMENT

control

No added plant sterol in the identical-looking rye bread

Group Type PLACEBO_COMPARATOR

Rye-2008

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Rye-2008

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* healthy
* volunteer
* hemoglobin above 125 mmol/L in females, above 135 mmol/L in males

Exclusion Criteria

* taking drugs affecting plasma lipids or gastrointestinal track
* severe illness
* use of antibiotics within 3 months before entering the study
* use of vitamin pills or fish oil 1 month before entering the study
* pregnancy or lactating

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes