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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01084226
Recruitment Status : Completed
First Posted : March 10, 2010
Last Update Posted : March 10, 2010
Samfundet Folkhälsan
Sigrid Jusélius Foundation
Fazer Bakeries
Information provided by:
Helsinki University

Brief Summary:
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 or disease Intervention/treatment Phase
Hypercholesterol Dietary Supplement: Rye-2008 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
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
Study Start Date : February 2008
Primary Completion Date : April 2009
Estimated Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

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 identifier (NCT number): 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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT01084226     History of Changes
Other Study ID Numbers: 1/13/03/00/08
First Posted: March 10, 2010    Key Record Dates
Last Update Posted: March 10, 2010
Last Verified: March 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