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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
  Purpose
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

  Eligibility

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
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT01084226


Locations
Finland
Folkhälsan Research Center
Helsinki, Finland, 00290
Sponsors and Collaborators
Helsinki University
Samfundet Folkhälsan
Sigrid Jusélius Foundation
Fazer Bakeries
Investigators
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 ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT01084226     History of Changes
Other Study ID Numbers: 1/13/03/00/08
First Submitted: March 9, 2010
First Posted: March 10, 2010
Last Update Posted: March 10, 2010
Last Verified: March 2010

Keywords provided by Helsinki University:
Rye fiber
Alkylresorcinols
Plant sterols
Cholesterol
Antioxidant
Effects of plant sterols in rye bread on serum lipids
Effects of alkylresorcinols in rye fiber on LDL particles