Drug ToxicityPhase 1NCT00491595
Phase I Clinical Study of Soy Isoflavones in Healthy, Post-Menopausal Women
A Phase 1 study testing High Dose Soy isoflavones in people with Drug Toxicity, run by University of North Carolina.
Trial summary
The purpose of this research study is to examine the safety of specific soy components, known as isoflavones, and to find out what effects (good and bad) these components have on tissues that are sensitive to the hormone estrogen in healthy, post-menopausal women. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Drug Toxicity
- What is being tested?
- High Dose Soy isoflavones
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Mar 2004to Jul 2005
- Phase
- Phase 1
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Performance status 0, 1, or 2 on ECOG scale
- Acceptable hematopoietic, hepatic, and renal function (WBC≥3500 µL, platelet count ≥ 100,000/ml, serum creatinine < 2.0 mg/dl, serum bilirubin ≤ 2.0 mg/dl, transaminases < two times normal limits)
- Post-menopausal status - FSH level > 27 mIU/ml, no spontaneous bleeding > 1 year
- Normal mammogram within the last 13 months
- Normal Papanicolaou Test within the last 13 months
Who cannot join
- Serious intercurrent medical illnesses or history of seizure
- Significant cardiac disease (New York Heart Association Class III or IV)
- Abnormalities on the physical examination screen including significant abnormality of the heart, lungs, liver, spleen, or other abdominal organs, or neurologic abnormality Abnormalities on the biochemical screen that could be metabolically significant
- Individuals with intermediate equol values (> 10 ug/L to < 20 ug/L) on soy challenge
- Use of antibiotics within the last 3 months
- Use of hormone/estrogen therapy or SERMs within the last 3 months
Show all 23Show fewer
- Abnormal thyroid or endocrine function tests; or current use of thyroid medication
- BMI at or above 35
- History of complete hysterectomy or oophorectomy
- High risk of breast cancer (5-year risk of >1.9%) based on NCI's Breast Cancer Risk Assessment Tool
- A history of a malignancy active or initially diagnosed within 2 years other than curatively treated non-melanoma carcinoma of the skin
- History of substance abuse or addiction
- Alcohol intake of greater than 2 drinks/day or 14 drinks/week
- Tobacco use
- Diets containing more than estimated intake of 20 mg genistein/day or 40mg isoflavone/day AND unwilling/unable to reduce soy intake to below this level during the study period
- Use of supplements containing phytoestrogens or that have estrogenic side effects within 1 month of study
- Pre-menopausal or pregnant
- Inability to read and comprehend the Informed Consent
- Life expectancy < 6 months
- History of breast cancer
- Known soy intolerance
- On chemotherapy within the last 2 years
- Inability to obtain an endometrial biopsy
About this study
Official title: Phase I Multiple-Dose Clinical Study of Soy Isoflavones in Healthy, Post-Menopausal Women
The purpose of this research study is to examine the safety of specific soy components, known as isoflavones, and to find out what effects (good and bad) these components have on tissues that are sensitive to the hormone estrogen in healthy, post-menopausal women. Isoflavones are compounds that occur naturally in soybeans and can be extracted to put in to capsule form or add to foods. The capsule formulation being used in this study is considered an investigational drug. This research is being done because many scientists believe that isoflavones may play a role in the prevention of some kinds of cancer. While isoflavones have been safely consumed in foods for centuries, we need to know if these soy components are safe to take in higher doses when they are extracted from foods and provided in a supplement form. We plan to test the safety and effects of the soy isoflavones known as genistein, daidzein and glycitein.
Read the detailed description
This will be a double blind, Phase I, multiple dose clinical trial of orally administered soy isoflavones (PTI G-2535, 70% unconjugated isoflavones containing genistein, daidzein, and glycitein). This preparation will be referred to as soy isoflavones in this and all study related documents to more accurately reflect the study drug's content. The multiple dose trial will last four months (112 days) and will include healthy, post-menopausal women as determined by FSH levels and lack of spontaneous bleeding for at least one year. After eligibility is determined, all potential subjects will ingest a soy shake to determine if they are producers of the daidzein metabolite, equol. We expect to find approximately 30% of our eligible subjects to be equol-producers as published in the literature. Equol producers will be defined as individuals with plasma levels >20ug/L; non-equol producers as those with <10ug/L 37. Individuals with intermediate equol values (> 10 ug/L to < 20 ug/L) will be excluded from the study. Stratified randomization will assign the subjects to one of the two groups, aiming for 30-40% equol producers in each group. Group 1 (20 subjects) will receive a dietary supplement containing 600 mg of genistein in two doses of 300 mg (as part of a soy isoflavones mixture) per day orally administered over an 84-day period. Group 2 (10 subjects) will receive a placebo supplement (excipients from the active formulation), orally administered over an 84-day period. These women will be recruited from the local population within the Research Triangle area. The study will be conducted at the UNC Hospital General Clinical Research Center (GCRC).
- Conditions
- Drug Toxicity
- Being tested
- High Dose Soy isoflavones
- Keywords
- Soy isoflavones, Genotoxicity, Apoptosis, Estrogenic effects
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Dose Soy isoflavonesDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
DNA damage, apoptosis, estrogenic effects and changes in gene expression
Measured: 112 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2007 (estimated)
- Study startMar 2004
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug ToxicityStudies 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 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Steven H Zeisel, MD, PhD, Principal investigator, UNC at Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00491595
- Sponsor's protocol ID
- NCI-N01-CN-75035
- Status last verified
- Jun 2007
- First submitted
- 22 Jun 2007
- Last updated
- 26 Jun 2007
- Results posted
- No
- Data monitoring committee
- Yes
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Multiple-Dose Clinical Study of Soy Isoflavones in Healthy, Post-Menopausal Women
- ClinicalTrials.gov ID
- NCT00491595
- Acronym / sponsor ID
- NCI-N01-CN-75035
- Conditions
- Drug Toxicity
- Keywords
- Soy isoflavones, Genotoxicity, Apoptosis, Estrogenic effects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of North CarolinaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2004
- Study completion
- Jul 2005 (actual)
- First posted
- 26 Jun 2007 (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 research study is to examine the safety of specific soy components, known as isoflavones, and to find out what effects (good and bad) these components have on tissues that are sensitive to the hormone estrogen in healthy, post-menopausal women. Isoflavones are compounds that occur naturally in soybeans and can be extracted to put in to capsule form or add to foods. The capsule formulation being used in this study is considered an investigational drug. This research is being done because many scientists believe that isoflavones may play a role in the prevention of some kinds of cancer. While isoflavones have been safely consumed in foods for centuries, we need to know if these soy components are safe to take in higher doses when they are extracted from foods and provided in a supplement form. We plan to test the safety and effects of the soy isoflavones known as genistein, daidzein and glycitein.
Detailed description
This will be a double blind, Phase I, multiple dose clinical trial of orally administered soy isoflavones (PTI G-2535, 70% unconjugated isoflavones containing genistein, daidzein, and glycitein). This preparation will be referred to as soy isoflavones in this and all study related documents to more accurately reflect the study drug's content. The multiple dose trial will last four months (112 days) and will include healthy, post-menopausal women as determined by FSH levels and lack of spontaneous bleeding for at least one year. After eligibility is determined, all potential subjects will ingest a soy shake to determine if they are producers of the daidzein metabolite, equol. We expect to find approximately 30% of our eligible subjects to be equol-producers as published in the literature. Equol producers will be defined as individuals with plasma levels >20ug/L; non-equol producers as those with <10ug/L 37. Individuals with intermediate equol values (> 10 ug/L to < 20 ug/L) will be excluded from the study. Stratified randomization will assign the subjects to one of the two groups, aiming for 30-40% equol producers in each group. Group 1 (20 subjects) will receive a dietary supplement containing 600 mg of genistein in two doses of 300 mg (as part of a soy isoflavones mixture) per day orally administered over an 84-day period. Group 2 (10 subjects) will receive a placebo supplement (excipients from the active formulation), orally administered over an 84-day period. These women will be recruited from the local population within the Research Triangle area. The study will be conducted at the UNC Hospital General Clinical Research Center (GCRC).
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Performance status 0, 1, or 2 on ECOG scale
- Acceptable hematopoietic, hepatic, and renal function (WBC≥3500 µL, platelet count ≥ 100,000/ml, serum creatinine < 2.0 mg/dl, serum bilirubin ≤ 2.0 mg/dl, transaminases < two times normal limits)
- Post-menopausal status - FSH level > 27 mIU/ml, no spontaneous bleeding > 1 year
- Normal mammogram within the last 13 months
- Normal Papanicolaou Test within the last 13 months
Key exclusion criteria (23 listed)
- Serious intercurrent medical illnesses or history of seizure
- Significant cardiac disease (New York Heart Association Class III or IV)
- Abnormalities on the physical examination screen including significant abnormality of the heart, lungs, liver, spleen, or other abdominal organs, or neurologic abnormality Abnormalities on the biochemical screen that could be metabolically significant
- Individuals with intermediate equol values (> 10 ug/L to < 20 ug/L) on soy challenge
- Use of antibiotics within the last 3 months
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 Dose Soy isoflavones | Drug | – |
Primary outcome
DNA damage, apoptosis, estrogenic effects and changes in gene expression
Time frame: 112 days
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 26 Jun 2007.
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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.
Steven H Zeisel, MD, PhD principal investigator
UNC at Chapel Hill
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing High Dose Soy isoflavones in people with Drug Toxicity, run by University of North Carolina.
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 5 inclusion and 23 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 26 Jun 2007. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
What does the primary outcome measure?
DNA damage, apoptosis, estrogenic effects and changes in gene expression (time frame: 112 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jun 2007.