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Rye Bread Trial; Antioxidative and Cholesterol Lowering Effects (Rye-2008)

This study has been completed.
Samfundet Folkhälsan
Sigrid Jusélius Foundation
Fazer Bakeries
Information provided by:
Helsinki University Identifier:
First received: March 9, 2010
Last updated: NA
Last verified: March 2010
History: No changes posted
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.

Condition Intervention Phase
Hypercholesterol Dietary Supplement: Rye-2008 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Official Title: Dietary Intervention Trial of Alkylresorcinols and Plant Sterols in High-Fibre Rye Bread and Their Effects on Serum Lipids in Normo- and Mildly Hypercholesterolemic Subjects

Resource links provided by NLM:

Further study details as provided by Helsinki University:

Enrollment: 68
Study Start Date: February 2008
Estimated Study Completion Date: February 2010
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sterol
Additional plant sterols incorporated in the rye bread
Dietary Supplement: Rye-2008
Placebo Comparator: control
No added plant sterol in the identical-looking rye bread
Dietary Supplement: Rye-2008


Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01084226

Folkhälsan Research Center
Helsinki, Finland, 00290
Sponsors and Collaborators
Helsinki University
Samfundet Folkhälsan
Sigrid Jusélius Foundation
Fazer Bakeries
Study Director: Matti J Tikkanen, M.D.. Prof. Department of Medicine, University of Helsinki, Helsinki, Finland
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT01084226     History of Changes
Other Study ID Numbers: 1/13/03/00/08
Study First Received: March 9, 2010
Last Updated: March 9, 2010

Keywords provided by Helsinki University:
Rye fiber
Plant sterols
Effects of plant sterols in rye bread on serum lipids
Effects of alkylresorcinols in rye fiber on LDL particles processed this record on September 19, 2017