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
  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: Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Helsinki University

Additional 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
Study First Received: March 9, 2010
Last Updated: March 9, 2010
Health Authority: Finland: Ethics committee at the Helsinki University Central Hospital

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

ClinicalTrials.gov processed this record on October 23, 2014