Breast CancerNCT00611104
Studying the Effect of Freeze-Dried Table Grape Powder on Blood Estrogen Levels in Postmenopausal Women
An observational study of Breast Cancer, run by Mayo Clinic at 1 site in United States.
Trial summary
RATIONALE: Estrogen can cause the growth of breast cancer cells. Studying samples of blood and urine in the laboratory from participants receiving freeze-dried table grape powder may help doctors understand the effect of this drug on blood estrogen levels. Read more about this study
- Who is it for?
- Ages 18 to 120 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- standardized freeze-dried table grape powder, laboratory biomarker analysis and pharmacological study
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2008to 22 Aug 2014
- Phase
- Observational
- 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 18 to 120 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Female * Postmenopausal (defined as women who have had both ovaries removed or no menstrual period for at least 12 consecutive months) * Able to give informed consent and complete food records alone or with assistance
DISEASE CHARACTERISTICS:
- Participant in the Mayo Mammography Health Study
- Has consented to provide baseline mammogram for digitization
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Female
- Postmenopausal (defined as women who have had both ovaries removed or no menstrual period for at least 12 consecutive months)
- Able to give informed consent and complete food records alone or with assistance
- Willing to provide research blood and urine samples
- Must be a non-smoker
- Willing to maintain current weight
- No history of breast ductal carcinoma in situ or any other cancer, except basal cell or squamous cell skin cancer or lobular carcinoma in situ
- No history of allergic or other adverse reaction to grapes
- No history of diabetes or glucose intolerance
PRIOR CONCURRENT THERAPY:
- No concurrent hormone therapy, including estradiol, estrone, or progestins
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Aromatase Inhibition Potential of Standardized Grape Extract
RATIONALE: Estrogen can cause the growth of breast cancer cells. Studying samples of blood and urine in the laboratory from participants receiving freeze-dried table grape powder may help doctors understand the effect of this drug on blood estrogen levels.
PURPOSE: This clinical trial is studying the effect of freeze-dried table grape powder on blood estrogen levels in postmenopausal women.
Read the detailed description
OBJECTIVES:
- To measure the change in levels of plasma estrone (E1), estradiol, E1-conjugates, and E1-sulfates in postmenopausal women after 6 weeks of daily ingestion of 94 grams of freeze-dried table grape powder.
- To conduct bioavailability research on the freeze-dried table grape powder in humans through the analysis of participants' blood and urine samples.
OUTLINE: Participants receive oral freeze-dried table grape powder once daily on days 1-42 in addition to their usual diet. Treatment continues in the absence of toxicity.
Participants undergo blood sample collection at baseline, periodically after the first dose, and on the last day of the study for pharmacokinetic and bioavailability analysis. Samples are examined by mass spectrometry to measure plasma levels of estrone (E1), estradiol, E1-conjugates, E1-sulfates, testosterone, and androstenedione. Participants also undergo spot urine collection and weight and height measurement periodically during study.
Participants complete food diaries on days 1-3, 21-23, and 40-42 to assess their intake of grapes, grape juice, and red wine and to examine the constancy of their caloric intake over the course of the study.
- Conditions
- Breast Cancer
- Being tested
- standardized freeze-dried table grape powder, laboratory biomarker analysis, pharmacological study
- Keywords
- breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standardized freeze-dried table grape powderDietary supplement
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum levels of plasma estrone (E1), estradiol, E1-conjugates, and E1-sulfates
Bioavailability of the freeze-dried table grape powder in humans
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2008 (estimated)
- Study start4 Aug 2008
- Primary completion22 Aug 2014
- Study completion22 Aug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Janet E. Olson, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00611104
- Sponsor's protocol ID
- MC0536
- Other IDs
- CDR0000581219, 06-002061
- Status last verified
- Sep 2024
- First submitted
- 7 Feb 2008
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Aromatase Inhibition Potential of Standardized Grape Extract
- ClinicalTrials.gov ID
- NCT00611104
- Acronym / sponsor ID
- MC0536
- Conditions
- Breast Cancer
- Keywords
- breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 4 Aug 2008 (actual)
- Primary completion
- 22 Aug 2014 (actual)
- Study completion
- 22 Aug 2014 (actual)
- First posted
- 8 Feb 2008 (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.
RATIONALE: Estrogen can cause the growth of breast cancer cells. Studying samples of blood and urine in the laboratory from participants receiving freeze-dried table grape powder may help doctors understand the effect of this drug on blood estrogen levels.
PURPOSE: This clinical trial is studying the effect of freeze-dried table grape powder on blood estrogen levels in postmenopausal women.
Detailed description
OBJECTIVES:
- To measure the change in levels of plasma estrone (E1), estradiol, E1-conjugates, and E1-sulfates in postmenopausal women after 6 weeks of daily ingestion of 94 grams of freeze-dried table grape powder.
- To conduct bioavailability research on the freeze-dried table grape powder in humans through the analysis of participants' blood and urine samples.
OUTLINE: Participants receive oral freeze-dried table grape powder once daily on days 1-42 in addition to their usual diet. Treatment continues in the absence of toxicity.
Participants undergo blood sample collection at baseline, periodically after the first dose, and on the last day of the study for pharmacokinetic and bioavailability analysis. Samples are examined by mass spectrometry to measure plasma levels of estrone (E1), estradiol, E1-conjugates, E1-sulfates, testosterone, and androstenedione. Participants also undergo spot urine collection and weight and height measurement periodically during study.
Participants complete food diaries on days 1-3, 21-23, and 40-42 to assess their intake of grapes, grape juice, and red wine and to examine the constancy of their caloric intake over the course of the study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Female * Postmenopausal (defined as women who have had both ovaries removed or no menstrual period for at least 12 consecutive months) * Able to give informed consent and complete food records alone or with assistance
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 |
|---|---|---|
| standardized freeze-dried table grape powder | Dietary supplement | – |
| laboratory biomarker analysis | Other | – |
| pharmacological study | Other | – |
Primary outcome
Serum levels of plasma estrone (E1), estradiol, E1-conjugates, and E1-sulfates
Bioavailability of the freeze-dried table grape powder in humans
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 19 Sep 2024.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Janet E. Olson, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 19 Sep 2024. 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 United States. 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?
Serum levels of plasma estrone (E1), estradiol, E1-conjugates, and E1-sulfates. 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?
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 19 Sep 2024; AzTrials last refreshed its copy on 6 Nov 2026.