HyperlipidemiaPhase 2NCT00877825
The Influence of Soy Isoflavnoids on the Hypocholesterolemic Effects of Soy
A Phase 2 study of Hyperlipidemia and Cardiovascular Diseases, run by University of Toronto.
Trial summary
Isoflavonoids, through their estrogen-like activity, are in part responsible for the cholesterol lowering properties of soy foods. If this is found to be so, then it would be advantageous not only to promote soy consumption, but also to identify and use soy cultivars with high isoflavonoid content in production of soy… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemia, Cardiovascular Diseases
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento Apr 2000
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- men and post-menopausal women
- LDL-C > 4.1mmol/L at recruitment
- living within a 40 km radius of St. Michael's Hospital
Who cannot join
- lipid lowering medications
- clinical or biochemical evidence of diabetes, renal or hepatic disease
- body mass index (BMI) >38 kg/m2
- antibiotic use within the last three months
- hormone replacement therapy
- smoking or significant alcohol use (>1 drink/d)
- triglyceride level > 4.0mmol/L
About this study
Isoflavonoids, through their estrogen-like activity, are in part responsible for the cholesterol lowering properties of soy foods. If this is found to be so, then it would be advantageous not only to promote soy consumption, but also to identify and use soy cultivars with high isoflavonoid content in production of soy food products. These foods may have a use in the reduction of serum cholesterol and if they effectively increase the phytoestrogen activity of soy, may have a role in the prevention of other hormone dependent diseases (e.g. osteoporosis, certain cancers) in the same way as natural estrogens.
- Conditions
- Hyperlipidemia, Cardiovascular Diseases
- Being tested
- dairy food control diet and high- and low- isoflavone soyfood diets
- Keywords
- Diet Therapy
- Medical subject headings
- Hyperlipidemias, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dairy food control diet and high- and low- isoflavone soyfood dietsProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2009 (estimated)
- Study completionApr 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Investigators
- David JA Jenkins, MD, PhD, DSc, Principal investigator, University of Toronto and St. Michael's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00877825
- Sponsor's protocol ID
- REB235U
- Status last verified
- Apr 2009
- First submitted
- 3 Apr 2009
- Last updated
- 8 Apr 2009
- Results posted
- No
Publications
Wong JM, Kendall CW, Marchie A, Liu Z, Vidgen E, Holmes C, Jackson CJ, Josse RG, Pencharz PB, Rao AV, Vuksan V, Singer W, Jenkins DJ. Equol status and blood lipid profile in hyperlipidemia after consumption of diets containing soy foods. Am J Clin Nutr. 2012 Mar;95(3):564-71. doi: 10.3945/ajcn.111.017418. Epub 2012 Feb 1.
PubMed 22301925
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Soy Isoflavnoids on the Hypocholesterolemic Effects of Soy
- ClinicalTrials.gov ID
- NCT00877825
- Acronym / sponsor ID
- REB235U
- Conditions
- Hyperlipidemia, Cardiovascular Diseases
- Keywords
- Diet Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study completion
- Apr 2000 (actual)
- First posted
- 8 Apr 2009 (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.
Isoflavonoids, through their estrogen-like activity, are in part responsible for the cholesterol lowering properties of soy foods. If this is found to be so, then it would be advantageous not only to promote soy consumption, but also to identify and use soy cultivars with high isoflavonoid content in production of soy food products. These foods may have a use in the reduction of serum cholesterol and if they effectively increase the phytoestrogen activity of soy, may have a role in the prevention of other hormone dependent diseases (e.g. osteoporosis, certain cancers) in the same way as natural estrogens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- men and post-menopausal women
- LDL-C > 4.1mmol/L at recruitment
- living within a 40 km radius of St. Michael's Hospital
Key exclusion criteria (7 listed)
- lipid lowering medications
- clinical or biochemical evidence of diabetes, renal or hepatic disease
- body mass index (BMI) >38 kg/m2
- antibiotic use within the last three months
- hormone replacement therapy
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 |
|---|---|---|
| dairy food control diet and high- and low- isoflavone soyfood diets | Procedure or surgery | – |
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 8 Apr 2009.
- Derived from this study: PubMed 22301925Wong JM, Kendall CW, Marchie A, Liu Z, Vidgen E, Holmes C, Jackson CJ, Josse RG, Pencharz PB, Rao AV, Vuksan V, Singer W, Jenkins DJ. Equol status and blood lipid profile in hyperlipidemia after consumption of diets containing soy foods. Am J Clin Nutr. 2012 Mar;95(3):564-71. doi: 10.3945/ajcn.111.017418. Epub 2012 Feb 1.
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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.
David JA Jenkins, MD, PhD, DSc principal investigator
University of Toronto and St. Michael's Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Hyperlipidemia and Cardiovascular Diseases, run by University of Toronto.
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 7 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 8 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 NCT00877825, which also lists 1 linked publication.
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 8 Apr 2009.