PostmenopauseISOIINCT01556737
Effect of Two Different Isoflavone Supplement Preparations on Gene-expression in Postmenopausal Women
A study testing High daidzein supplement and High genistein supplement in people with Postmenopause, run by Wageningen University at 1 site in Netherlands.
Trial summary
Alleged benefits experienced after 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 50 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopause
- What is being tested?
- High daidzein supplement and High genistein supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2011to Sep 2012
- 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 50 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female
- 50-70 years
- 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 sexhormones or sexhormone-triggering compounds
- current use of anti-inflammatory medicines
Show all 17Show fewer
- use of antibiotics in the past 3 months
- severe heart disease
- diabetes
- thyroid disorders --> use of medicines for thyroid disorders
- removed thyroid gland
- complete ovarectomy
- prior diagnosis of cancer
- alcohol and drug abuse
- current smoker
- BMI >35 kg/m2
- allergy to soy (products)
Trial locations and contacts
1 site in 1 country.
About this study
Alleged benefits experienced after 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 are on the market in different compositions. The question is whether supplements with different compositions exert similar effects or whether the effects differ substantially.
Read the detailed description
Intervention study with two substudies; each substudy is a double blind placebo controlled crossover intervention study. The first substudy has two groups: 'high daidzein' supplement versus placebo (n=18) and vice versa (n=18); the second substudy also has two groups 'high genistein' versus placebo (n=18) and vice versa (n=18).
- Conditions
- Postmenopause
- Being tested
- High daidzein supplement, High genistein supplement
- Keywords
- isoflavone, supplement, daidzein, genistein, gene expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High daidzein supplementDietary supplement
Also called Phyto soya forte - Arkpharma
8 weeks exposure to the supplement, daily 100 mg of isoflavones
High genistein supplementDietary supplement
Also called Mega Soja - Springfield
8 weeks exposure to the supplement, daily 100 mg of isoflavones
| Study group | Role | What they receive |
|---|---|---|
| Supplement | Experimental | Not described Receives: Dietary Supplement: High daidzein supplement; Dietary Supplement: High genistein supplement |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: High daidzein supplement; Dietary Supplement: High genistein supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene-expression in PBMCs
after placebo vs after treatment measured by microarrays
Measured: after 8 weeks exposure to supplement vs after 8 weeks exposure to placebo
Secondary outcomes (3)
Isoflavone levels in plasma
after placebo vs after treatment measured by HPLC
Measured: before and after 8 weeks exposure to supplement vs before and after 8 weeks exposure to placebo
Gene - expression in adipose tissue
after placebo vs after treatment measured by QPCR
Measured: after 8 weeks exposure to supplement vs after 8 weeks exposure to placebo
Isoflavone levels in adipose tissue
levels after placebo vs levels after treatment measured by HPLC
Measured: after 8 weeks exposure to supplement vs after 8 weeks exposure to placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2012 (estimated)
- Study startNov 2011
- Primary completionSep 2012
- Study completionSep 2012
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
- 72 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, Prof, Principal investigator, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01556737
- Sponsor's protocol ID
- NL37475.081.11
- Other IDs
- ISO II study
- Acronym
- ISOII
- Status last verified
- Oct 2012
- First submitted
- 9 Jan 2012
- Last updated
- 31 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
van der Velpen V, Geelen A, Hollman PC, Schouten EG, van 't Veer P, Afman LA. Isoflavone supplement composition and equol producer status affect gene expression in adipose tissue: a double-blind, randomized, placebo-controlled crossover trial in postmenopausal women. Am J Clin Nutr. 2014 Nov;100(5):1269-77. doi: 10.3945/ajcn.114.088484. Epub 2014 Aug 20.
PubMed 25332325
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Two Different Isoflavone Supplement Preparations on Gene-expression in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT01556737
- Acronym / sponsor ID
- ISOII / NL37475.081.11
- Conditions
- Postmenopause
- Keywords
- isoflavone, supplement, daidzein, genistein, gene expression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 16 Mar 2012 (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 after 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 are on the market in different compositions. The question is whether supplements with different compositions exert similar effects or whether the effects differ substantially.
Detailed description
Intervention study with two substudies; each substudy is a double blind placebo controlled crossover intervention study. The first substudy has two groups: 'high daidzein' supplement versus placebo (n=18) and vice versa (n=18); the second substudy also has two groups 'high genistein' versus placebo (n=18) and vice versa (n=18).
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supplement | Experimental | Dietary Supplement: High daidzein supplement, Dietary Supplement: High genistein supplement |
| Placebo | Placebo comparator | Dietary Supplement: High daidzein supplement, Dietary Supplement: High genistein supplement |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female
- 50-70 years
- menstrual cycle absent for more than 1 year
Key exclusion criteria (17 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 sexhormones or sexhormone-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 |
|---|---|---|
| High daidzein supplementAlso: Phyto soya forte - Arkpharma8 weeks exposure to the supplement, daily 100 mg of isoflavones | Dietary supplement | Placebo, Supplement |
| High genistein supplementAlso: Mega Soja - Springfield8 weeks exposure to the supplement, daily 100 mg of isoflavones | Dietary supplement | Placebo, Supplement |
Primary outcome
Gene-expression in PBMCs
Time frame: after 8 weeks exposure to supplement vs after 8 weeks exposure to placebo
after placebo vs after treatment measured by microarrays
3 secondary outcomes
Isoflavone levels in plasma
Time frame: before and after 8 weeks exposure to supplement vs before and after 8 weeks exposure to placebo
Gene - expression in adipose tissue
Time frame: after 8 weeks exposure to supplement vs after 8 weeks exposure to placebo
Isoflavone levels in adipose tissue
Time frame: after 8 weeks exposure to supplement vs after 8 weeks exposure to 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 31 Oct 2012.
- Derived from this study: PubMed 25332325van der Velpen V, Geelen A, Hollman PC, Schouten EG, van 't Veer P, Afman LA. Isoflavone supplement composition and equol producer status affect gene expression in adipose tissue: a double-blind, randomized, placebo-controlled crossover trial in postmenopausal women. Am J Clin Nutr. 2014 Nov;100(5):1269-77. doi: 10.3945/ajcn.114.088484. Epub 2014 Aug 20.
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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, Prof 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 High daidzein supplement and High genistein 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 3 inclusion and 17 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 31 Oct 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. 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.
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 in PBMCs (time frame: after 8 weeks exposure to supplement vs after 8 weeks exposure to placebo). 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 NCT01556737, 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 31 Oct 2012.