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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01084226
First Posted: March 10, 2010
Last Update Posted: March 10, 2010
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.
Collaborators:
Samfundet Folkhälsan
Sigrid Jusélius Foundation
Fazer Bakeries
Information provided by:
Helsinki University
March 9, 2010
March 10, 2010
March 10, 2010
February 2008
April 2009   (Final data collection date for primary outcome measure)
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No Changes Posted
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Rye Bread Trial; Antioxidative and Cholesterol Lowering Effects
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
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.
Not Provided
Interventional
Phase 2
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Hypercholesterol
Dietary Supplement: Rye-2008
  • Active Comparator: Sterol
    Additional plant sterols incorporated in the rye bread
    Intervention: Dietary Supplement: Rye-2008
  • Placebo Comparator: control
    No added plant sterol in the identical-looking rye bread
    Intervention: Dietary Supplement: Rye-2008

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
68
February 2010
April 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Finland
 
 
NCT01084226
1/13/03/00/08
Not Provided
Not Provided
Not Provided
Not Provided
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
Helsinki University
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP