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:

MedlinePlus related topics: Cholesterol Dietary Fiber

U.S. FDA Resources

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

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):

Söderholm 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. Epub 2012 Jan 25.

Söderholm 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. Epub 2011 Jan 6.

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 May 16, 2013

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