- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01084226
Rye Bread Trial; Antioxidative and Cholesterol Lowering Effects (Rye-2008)
March 9, 2010 updated by: University of Helsinki
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
68
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Helsinki, Finland, 00290
- Folkhälsan Research Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Sterol
Additional plant sterols incorporated in the rye bread
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Placebo Comparator: control
No added plant sterol in the identical-looking rye bread
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Matti J Tikkanen, M.D.. Prof., Department of Medicine, University of Helsinki, Helsinki, Finland
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Soderholm PP, Alfthan G, Tikkanen MJ, Adlercreutz H. Rye bread intake improves oxidation resistance of LDL in healthy humans. Atherosclerosis. 2012 Apr;221(2):583-6. doi: 10.1016/j.atherosclerosis.2012.01.030. Epub 2012 Jan 25.
- Soderholm PP, Alfthan G, Koskela AH, Adlercreutz H, Tikkanen MJ. The effect of high-fiber rye bread enriched with nonesterified plant sterols on major serum lipids and apolipoproteins in normocholesterolemic individuals. Nutr Metab Cardiovasc Dis. 2012 Jul;22(7):575-82. doi: 10.1016/j.numecd.2010.09.011. Epub 2011 Jan 6.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2008
Primary Completion (Actual)
April 1, 2009
Study Completion
February 1, 2010
Study Registration Dates
First Submitted
March 9, 2010
First Submitted That Met QC Criteria
March 9, 2010
First Posted (Estimate)
March 10, 2010
Study Record Updates
Last Update Posted (Estimate)
March 10, 2010
Last Update Submitted That Met QC Criteria
March 9, 2010
Last Verified
March 1, 2010
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1/13/03/00/08
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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