HypercholesterolPhase 2Rye-2008NCT01084226
Rye Bread Trial; Antioxidative and Cholesterol Lowering Effects
A Phase 2 study testing Rye-2008 in people with Hypercholesterol, run by University of Helsinki at 1 site in Finland.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterol
- What is being tested?
- Rye-2008
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteFinland
- Study dates
- Feb 2008to Feb 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy
- volunteer
- hemoglobin above 125 mmol/L in females, above 135 mmol/L in males
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Hypercholesterol
- Being tested
- Rye-2008
- Keywords
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rye-2008Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Sterol | Active comparator | Additional plant sterols incorporated in the rye bread Receives: Dietary Supplement: Rye-2008 |
| control | Placebo comparator | No added plant sterol in the identical-looking rye bread Receives: Dietary Supplement: Rye-2008 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2010 (estimated)
- Study startFeb 2008
- Primary completionApr 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Collaborators
- Samfundet Folkhälsan, Sigrid Jusélius Foundation, Fazer
- Investigators
- Matti J Tikkanen, M.D.. Prof., Study director, Department of Medicine, University of Helsinki, Helsinki, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01084226
- Sponsor's protocol ID
- 1/13/03/00/08
- Acronym
- Rye-2008
- Status last verified
- Mar 2010
- First submitted
- 9 Mar 2010
- Last updated
- 10 Mar 2010
- Results posted
- No
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.
PubMed 22336172Soderholm 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.
PubMed 21215605
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01084226
- Acronym / sponsor ID
- Rye-2008 / 1/13/03/00/08
- Conditions
- Hypercholesterol
- Keywords
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- Samfundet Folkhälsan, Sigrid Jusélius Foundation, Fazer
- Study start
- Feb 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Feb 2010
- First posted
- 10 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sterol | Active comparator | Dietary Supplement: Rye-2008Additional plant sterols incorporated in the rye bread |
| control | Placebo comparator | Dietary Supplement: Rye-2008No added plant sterol in the identical-looking rye bread |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- healthy
- volunteer
- hemoglobin above 125 mmol/L in females, above 135 mmol/L in males
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rye-2008 | Dietary supplement | Sterol, control |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2010.
- Derived from this study: PubMed 22336172Soderholm 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.
- Derived from this study: PubMed 21215605Soderholm 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matti J Tikkanen, M.D.. Prof. study director
Department of Medicine, University of Helsinki, Helsinki, Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rye-2008 in people with Hypercholesterol, run by University of Helsinki at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01084226, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2010.