NCT01084226

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 9, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 10, 2010

Completed
Last Updated

March 10, 2010

Status Verified

March 1, 2010

Enrollment Period

1.2 years

First QC Date

March 9, 2010

Last Update Submit

March 9, 2010

Conditions

Hypercholesterol

Keywords

Rye fiberAlkylresorcinolsPlant sterolsCholesterolAntioxidantEffects of plant sterols in rye bread on serum lipidsEffects of alkylresorcinols in rye fiber on LDL particles

Study Arms (2)

Sterol

ACTIVE COMPARATOR

Additional plant sterols incorporated in the rye bread

Dietary Supplement: Rye-2008

control

PLACEBO COMPARATOR

No added plant sterol in the identical-looking rye bread

Dietary Supplement: Rye-2008

Interventions

Rye-2008DIETARY_SUPPLEMENT
Sterolcontrol

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy
  • volunteer
  • hemoglobin above 125 mmol/L in females, above 135 mmol/L in males

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Folkhälsan Research Center

Helsinki, Helsinki, 00290, Finland

Location

Related Publications (2)

  • 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.

    PMID: 22336172DERIVED

  • 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.

    PMID: 21215605DERIVED

Study Officials

  • Matti J Tikkanen, M.D.. Prof.

    Department of Medicine, University of Helsinki, Helsinki, Finland

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 9, 2010

First Posted

March 10, 2010

Study Start

February 1, 2008

Primary Completion

April 1, 2009

Study Completion

February 1, 2010

Last Updated

March 10, 2010

Record last verified: 2010-03

Locations

FI(1)