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

This study has been completed.
Sponsor:
Collaborators:
Samfundet Folkhälsan
Sigrid Jusélius Foundation
Fazer Bakeries
Information provided by:
Helsinki University
ClinicalTrials.gov Identifier:
NCT01084226
First received: March 9, 2010
Last updated: NA
Last verified: March 2010
History: No changes posted

March 9, 2010
March 9, 2010
February 2008
April 2009   (final data collection date for primary outcome measure)
Not Provided
Not Provided
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
Both
20 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT01084226
1/13/03/00/08
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