PostmenopauseISONCT01232751
Effects of Isoflavones on Gene-expression
A study testing Isoflavone supplement in people with Postmenopause, run by Wageningen University at 1 site in Netherlands.
Trial summary
Alleged benefits experienced by the consumption of soy in Asian countries have been attributed to the isoflavone content of soy products. Amongst other benefits, isoflavones are believed to relieve menopausal symptoms and are therefore often consumed in supplement form in Western countries. Read more about this study
- Who is it for?
- Ages 45 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopause
- What is being tested?
- Isoflavone supplement
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2010to Oct 2011
- Phase
- Interventional
- 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 45 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 45-70 years
- Equol producer
- Post-menopausal (Follicle Stimulating Hormone (FSH) >40 UI/L) or
- menstrual cycle absent for more than 1 year.
Who cannot join
- current use of contraceptives containing hormones
- current use of hormone replacement therapy
- regular soy product use (more than once a week)
- regular isoflavone supplement use (more than once a week)
- current use of medication containing sex hormones or sex hormone-triggering compounds
- current use of anti-inflammatory medicines
Show all 16Show fewer
- use of antibiotics in the past 6 months
- severe heart disease
- thyroid disorders
- removed thyroid gland
- complete ovariectomy
- prior diagnosis of cancer in medical history
- alcohol and drug abuse
- current smoker
- Body Mass Index (BMI) >35 kg/m2
- allergy to soy (products)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Isoflavone Supplement Intake on Gene-expression in Postmenopausal Women
Alleged benefits experienced by the consumption of soy in Asian countries have been attributed to the isoflavone content of soy products. Amongst other benefits, isoflavones are believed to relieve menopausal symptoms and are therefore often consumed in supplement form in Western countries. These supplements contain relatively high amounts of isoflavones, and the question is if these concentrations still exert beneficial effects or whether negative effects become dominant. Therefore, the investigators will study the effect of intake of one dose of isoflavones, as compared to placebo, for eight weeks on gene-expression in Peripheral Blood Mononuclear Cells (PBMCs) in post-menopausal, equol-producing women.
Read the detailed description
Primary Objective: to determine the effect of intake of one dose of isoflavones, as compared to placebo, for eight weeks on gene-expression in Peripheral Blood Mononuclear Cells (PBMCs) in post-menopausal, equol-producing women.
Secondary Objectives: to determine the association between isoflavone plasma levels and gene-expression in PBMCs; to determine the variation of isoflavone plasma levels between subjects after intake of isoflavones for four and eight weeks; to explore whether PBMC gene-expression markers identified after 8 weeks isoflavone intervention are already present after 4 weeks intervention; to explore whether the severity of previous menopausal complaints is related to the effect of isoflavones on PBMC gene-expression; and to explore the association between isoflavone levels in plasma and spot urine.
Study design: Double-blind placebo controlled crossover intervention study
Study population: Thirty-six healthy females, 45-70 years, post-menopausal and equol-producing
Intervention: Two intervention periods of eight weeks with a isoflavone supplement or a placebo and a washout period of 8 weeks in between.
Main study parameters/endpoints: The main study parameter is gene-expression in PBMCs measured by micro-arrays.
- Conditions
- Postmenopause
- Being tested
- Isoflavone supplement
- Keywords
- health, women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isoflavone supplementDietary supplement
Also called Phytosoya forte (35mg) from the company Arkopharma
The participants will consume 2 times 2 supplements per day, which will lead to a daily dose of 114 mg. (HPLC analysis confirmed an aglycone isoflavone content of 28.41 mg per supplement)
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene-expression measured by micro-arrays
Gene expression changes will be assessed in PBMCs using whole genome Affymetrix microarrays. The gene expression changes after exposure to the isoflavone supplement will be compared to the changes after exposure to the placebo.
Measured: gene-expression after 8 weeks of exposure to the isoflavone supplement
Gene-expression measured by micro-arrays
Gene expression changes will be assessed in PBMCs using whole genome Affymetrix microarrays. The gene expression changes after exposure to the isoflavone supplement will be compared to the changes after exposure to the placebo.
Measured: after 8 weeks of exposure to the placebo
Secondary outcomes (12)
Isoflavone levels in plasma and spoturine
levels of the isoflavones genistein, dihydrogenistein, daidzein, dihydrodaidzein, equol and glycitein will be measured with High performance liquid chromatography (HPLC). Following the intention to treat analysis, these concentration markers will be determined in order to correlate the gene-expression measured with quantitative real-time polymerase chain reaction (QPCR) with the isoflavone plasma levels, and to stratify for the plasma levels in per protocol analysis.
Measured: after 0 weeks of exposure to the isoflavone supplement
Isoflavone levels in plasma and spoturine
levels of the isoflavones genistein, dihydrogenistein, daidzein, dihydrodaidzein, equol and glycitein will be measured with HPLC. Following the intention to treat analysis, these concentration markers will be determined in order to correlate the gene-expression measured with QPCR with the isoflavone plasma levels, and to stratify for the plasma levels in per protocol analysis.
Measured: after 4 weeks of exposure to the isoflavone supplement
Isoflavone levels in plasma and spoturine
levels of the isoflavones genistein, dihydrogenistein, daidzein, dihydrodaidzein, equol and glycitein will be measured with HPLC. Following the intention to treat analysis, these concentration markers will be determined in order to correlate the gene-expression measured with QPCR with the isoflavone plasma levels, and to stratify for the plasma levels in per protocol analysis.
Measured: after 8 weeks of exposure to the isoflavone supplement
Isoflavone levels in plasma and spoturine
levels of the isoflavones genistein, dihydrogenistein, daidzein, dihydrodaidzein, equol and glycitein will be measured with HPLC. Following the intention to treat analysis, these concentration markers will be determined in order to correlate the gene-expression measured with QPCR with the isoflavone plasma levels, and to stratify for the plasma levels in per protocol analysis.
Measured: after 0 weeks of exposure to the placebo
Isoflavone levels in plasma and spoturine
levels of the isoflavones genistein, dihydrogenistein, daidzein, dihydrodaidzein, equol and glycitein will be measured with HPLC. Following the intention to treat analysis, these concentration markers will be determined in order to correlate the gene-expression measured with QPCR with the isoflavone plasma levels, and to stratify for the plasma levels in per protocol analysis.
Measured: after 4 weeks of exposure to the placebo
Isoflavone levels in plasma and spoturine
levels of the isoflavones genistein, dihydrogenistein, daidzein, dihydrodaidzein, equol and glycitein will be measured with HPLC. Following the intention to treat analysis, these concentration markers will be determined in order to correlate the gene-expression measured with QPCR with the isoflavone plasma levels, and to stratify for the plasma levels in per protocol analysis.
Measured: after 8 weeks of exposure to the placebo
Confirmation of gene-expression with quantitative real time polymerase chain reaction (QPCR)
Ten genes per sample will be verified with QPCR. PBMCs from the subjects are available at time points before, halfway and after the two intervention periods. On the basis of the micro-array results it will be decided which genes from which samples will be quantified.
Measured: after 0 weeks of exposure to the isoflavone supplement
Confirmation of gene-expression with quantitative real time polymerase chain reaction (QPCR)
Ten genes per sample will be verified with QPCR. PBMCs from the subjects are available at time points before, halfway and after the two intervention periods. On the basis of the micro-array results it will be decided which genes from which samples will be quantified.
Measured: after 4 weeks of exposure to the isoflavone supplement
Confirmation of gene-expression with quantitative real time polymerase chain reaction (QPCR)
Ten genes per sample will be verified with QPCR. PBMCs from the subjects are available at time points before, halfway and after the two intervention periods. On the basis of the micro-array results it will be decided which genes from which samples will be quantified.
Measured: after 0 weeks of exposure to the placebo
Confirmation of gene-expression with quantitative real time polymerase chain reaction (QPCR)
Ten genes per sample will be verified with QPCR. PBMCs from the subjects are available at time points before, halfway and after the two intervention periods. On the basis of the micro-array results it will be decided which genes from which samples will be quantified.
Measured: after 8 weeks of exposure to the isoflavone supplement
Confirmation of gene-expression with quantitative real time polymerase chain reaction (QPCR)
Ten genes per sample will be verified with QPCR. PBMCs from the subjects are available at time points before, halfway and after the two intervention periods. On the basis of the micro-array results it will be decided which genes from which samples will be quantified.
Measured: after 4 weeks of exposure to the placebo
Confirmation of gene-expression with quantitative real time polymerase chain reaction (QPCR)
Ten genes per sample will be verified with QPCR. PBMCs from the subjects are available at time points before, halfway and after the two intervention periods. On the basis of the micro-array results it will be decided which genes from which samples will be quantified.
Measured: after 8 weeks of exposure to the placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2010 (estimated)
- Study startAug 2010
- Primary completionOct 2011
- Study completionOct 2011
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 PostmenopauseStudies 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 N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisette de Groot, Wageningen University
- Investigators
- Pieter van 't Veer, Professor, Principal investigator, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01232751
- Sponsor's protocol ID
- NL 32375.081.10
- Acronym
- ISO
- Status last verified
- Jan 2012
- First submitted
- 21 Oct 2010
- Last updated
- 10 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
van der Velpen V, Geelen A, Schouten EG, Hollman PC, Afman LA, van 't Veer P. Estrogen receptor-mediated effects of isoflavone supplementation were not observed in whole-genome gene expression profiles of peripheral blood mononuclear cells in postmenopausal, equol-producing women. J Nutr. 2013 Jun;143(6):774-80. doi: 10.3945/jn.113.174037. Epub 2013 Apr 24.
PubMed 23616509
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Isoflavone Supplement Intake on Gene-expression in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT01232751
- Acronym / sponsor ID
- ISO / NL 32375.081.10
- Conditions
- Postmenopause
- Keywords
- health, women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 2 Nov 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.
Alleged benefits experienced by the consumption of soy in Asian countries have been attributed to the isoflavone content of soy products. Amongst other benefits, isoflavones are believed to relieve menopausal symptoms and are therefore often consumed in supplement form in Western countries. These supplements contain relatively high amounts of isoflavones, and the question is if these concentrations still exert beneficial effects or whether negative effects become dominant. Therefore, the investigators will study the effect of intake of one dose of isoflavones, as compared to placebo, for eight weeks on gene-expression in Peripheral Blood Mononuclear Cells (PBMCs) in post-menopausal, equol-producing women.
Detailed description
Primary Objective: to determine the effect of intake of one dose of isoflavones, as compared to placebo, for eight weeks on gene-expression in Peripheral Blood Mononuclear Cells (PBMCs) in post-menopausal, equol-producing women.
Secondary Objectives: to determine the association between isoflavone plasma levels and gene-expression in PBMCs; to determine the variation of isoflavone plasma levels between subjects after intake of isoflavones for four and eight weeks; to explore whether PBMC gene-expression markers identified after 8 weeks isoflavone intervention are already present after 4 weeks intervention; to explore whether the severity of previous menopausal complaints is related to the effect of isoflavones on PBMC gene-expression; and to explore the association between isoflavone levels in plasma and spot urine.
Study design: Double-blind placebo controlled crossover intervention study
Study population: Thirty-six healthy females, 45-70 years, post-menopausal and equol-producing
Intervention: Two intervention periods of eight weeks with a isoflavone supplement or a placebo and a washout period of 8 weeks in between.
Main study parameters/endpoints: The main study parameter is gene-expression in PBMCs measured by micro-arrays.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 45-70 years
- Equol producer
- Post-menopausal (Follicle Stimulating Hormone (FSH) >40 UI/L) or
- menstrual cycle absent for more than 1 year.
Key exclusion criteria (16 listed)
- current use of contraceptives containing hormones
- current use of hormone replacement therapy
- regular soy product use (more than once a week)
- regular isoflavone supplement use (more than once a week)
- current use of medication containing sex hormones or sex hormone-triggering compounds
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 |
|---|---|---|
| Isoflavone supplementAlso: Phytosoya forte (35mg) from the company ArkopharmaThe participants will consume 2 times 2 supplements per day, which will lead to a daily dose of 114 mg. (HPLC analysis confirmed an aglycone isoflavone content of 28.41 mg per supplement) | Dietary supplement | – |
Primary outcome
Gene-expression measured by micro-arrays
Time frame: gene-expression after 8 weeks of exposure to the isoflavone supplement
Gene expression changes will be assessed in PBMCs using whole genome Affymetrix microarrays. The gene expression changes after exposure to the isoflavone supplement will be compared to the changes after exposure to the placebo.
Gene-expression measured by micro-arrays
Time frame: after 8 weeks of exposure to the placebo
Gene expression changes will be assessed in PBMCs using whole genome Affymetrix microarrays. The gene expression changes after exposure to the isoflavone supplement will be compared to the changes after exposure to the placebo.
12 secondary outcomes
Isoflavone levels in plasma and spoturine
Time frame: after 0 weeks of exposure to the isoflavone supplement
Isoflavone levels in plasma and spoturine
Time frame: after 4 weeks of exposure to the isoflavone supplement
Isoflavone levels in plasma and spoturine
Time frame: after 8 weeks of exposure to the isoflavone supplement
Isoflavone levels in plasma and spoturine
Time frame: after 0 weeks of exposure to the placebo
Isoflavone levels in plasma and spoturine
Time frame: after 4 weeks of exposure to the placebo
Isoflavone levels in plasma and spoturine
Time frame: after 8 weeks of exposure to the placebo
Confirmation of gene-expression with quantitative real time polymerase chain reaction (QPCR)
Time frame: after 0 weeks of exposure to the isoflavone supplement
Confirmation of gene-expression with quantitative real time polymerase chain reaction (QPCR)
Time frame: after 4 weeks of exposure to the isoflavone supplement
Confirmation of gene-expression with quantitative real time polymerase chain reaction (QPCR)
Time frame: after 0 weeks of exposure to the placebo
Confirmation of gene-expression with quantitative real time polymerase chain reaction (QPCR)
Time frame: after 8 weeks of exposure to the isoflavone supplement
Confirmation of gene-expression with quantitative real time polymerase chain reaction (QPCR)
Time frame: after 4 weeks of exposure to the placebo
Confirmation of gene-expression with quantitative real time polymerase chain reaction (QPCR)
Time frame: after 8 weeks of exposure to the placebo
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 Jan 2012.
- Derived from this study: PubMed 23616509van der Velpen V, Geelen A, Schouten EG, Hollman PC, Afman LA, van 't Veer P. Estrogen receptor-mediated effects of isoflavone supplementation were not observed in whole-genome gene expression profiles of peripheral blood mononuclear cells in postmenopausal, equol-producing women. J Nutr. 2013 Jun;143(6):774-80. doi: 10.3945/jn.113.174037. Epub 2013 Apr 24.
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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.
Pieter van 't Veer, Professor principal investigator
Wageningen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isoflavone supplement in people with Postmenopause, run by Wageningen University at 1 site in Netherlands.
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 4 inclusion and 16 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 Jan 2012. 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 Netherlands. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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.
What does the primary outcome measure?
Gene-expression measured by micro-arrays (time frame: gene-expression after 8 weeks of exposure to the isoflavone supplement). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01232751, 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 10 Jan 2012.