Healthy, no Evidence of DiseasePhase 1NCT01370889
Resveratrol in Postmenopausal Women With High Body Mass Index
A Phase 1 study testing resveratrol and laboratory biomarker analysis in people with Healthy, no Evidence of Disease, run by National Cancer Institute (NCI) at 2 sites in United States.
Trial summary
This pilot phase I trial studies resveratrol in postmenopausal women with high body mass index. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of resveratrol may keep cancer from forming. Read more about this study
- Who is it for?
- Ages 35 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, no Evidence of Disease
- What is being tested?
- resveratrol and laboratory biomarker analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2011to Jul 2012
- 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 35 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy postmenopausal women with a body mass index (BMI) of 25 kg/m^2 or greater
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1; Karnofsky 70% or above
- Leukocytes >= 3,000/uL
- Absolute neutrophil count (ANC) >= 1,500/uL
- Platelets >= 100,000/uL
- Total bilirubin =< 2.0 mg/dL
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- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 1.5 times upper limit of normal (ULN)
- Creatinine =< 1.0 times ULN
- Ability and willingness to limit resveratrol-containing foods to no more than one serving each per day for about 14 weeks
- Negative mammogram or negative workup of mammographic findings within prior 12 months prior to enrollment for women >= 50 years of age
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Have had invasive cancer(s) within the past 5 years except non-melanoma skin cancer
- Within 3 months of or concurrent usage of any other investigational agents
- History of allergic reactions attributed to resveratrol
- Unwilling or unable to refrain from taking herbal medicines and dietary supplements
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Within 3 months of or concurrent estrogen or progesterone replacement therapy, oral contraceptives, androgens, luteinizing hormone-releasing hormone analogs, prolactin inhibitors, or antiandrogens; vaginal estrogen is acceptable.
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- Within 3 months of or concurrent usage of tamoxifen, raloxifene, other selective estrogen-receptor modulators, or aromatase inhibitors
- Regular usage (more than 2 times a week) of estrogenic supplements or herbal remedies (e.g., Remifemin, black cohosh, red clover, dong quai, soy isoflavones, dehydroepiandrosterone [DHEA], flaxseed, diindolylmethane [DIM], genistein, and daidzein) within the past 3 months or concurrently; dietary consumption of phytoestrogens/isoflavones (such as soy, tofu, millet, barley, natto, tempeh, miso, soy milk, soy sauce) is acceptable as these sources are not concentrated
- Concurrent use of anti-diabetic drugs such as:
- Insulin
- Sulfonylureas (e.g., glipizide, glyburide, or glimepiride)
- Meglitinides (e.g., repaglinide or nateglinide)
- Biguanides (e.g., metformin)
- Thiazolidinediones (e.g., rosiglitazone or pioglitazone)
- Alpha-glucosidase inhibitors (e.g., acarbose or miglitol)
- Dipeptidyl peptidase-4 (DPP-4) inhibitors (e.g., sitagliptin)
- Concurrent use of warfarin or phenytoin
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Arizona Cancer Center - Tucson
Tucson, Arizona, 85724-5024
University of Arizona Health Sciences Center
Tucson, Arizona, 85724
About this study
Official title: Pilot Study of Resveratrol in Postmenopausal Women With High Body Mass Index
This pilot phase I trial studies resveratrol in postmenopausal women with high body mass index. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of resveratrol may keep cancer from forming. Studying samples of blood and urine in the laboratory from postmenopausal women who are taking resveratrol may help doctors learn more about the effects of resveratrol on biomarkers.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the effect of pharmacological doses of resveratrol on serum estradiol levels in post-menopausal women with high body mass index (BMI).
SECONDARY OBJECTIVES:
- Assess the effect of resveratrol on serum estrone, testosterone, and sex hormone-binding globulin (SHBP).
II. Assess the effect of resveratrol on serum levels of insulin and C-peptide. III. Assess the effect of resveratrol on adipocytokine expression and secretion as measured by serum leptin and adiponectin.
IV. Assess the effect of resveratrol on inflammatory cytokines as measured by serum C-reactive protein (CRP).
- Assess the effect of resveratrol on oxidative stress as measured by urinary 8-isoprostaglandin F2 alpha (8-iso-PGF2 alpha) and 8-hydroxydeoxyguanosine (8OHdG).
VI. Assess the safety of resveratrol intervention as measured by reported adverse events, complete blood count with differential (CBC/diff), comprehensive metabolic panel (CMP), and lipid profile.
VII. Assess the relationship between systemic study agent exposure and biomarker modulation.
OUTLINE:
Patients receive resveratrol orally (PO) once daily (QD) for 12 weeks.
After completion of study therapy, patients are followed up for 2 weeks
- Conditions
- Healthy, no Evidence of Disease
- Being tested
- resveratrol, laboratory biomarker analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resveratrolDrug
Given PO
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Basic Science (resveratrol) | Experimental | Patients receive resveratrol PO QD for 12 weeks. Receives: Drug: resveratrol; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum estradiol levels in postmenopausal women with high BMI
A two-sided paired t-test will be performed to determine whether the change is significant at a significance level of 5%. If the data distribution indicates non-normality or skewedness in violation of the assumptions of the t-test, non-parametric tests will be used. Linear regression techniques will be used to adjust for potential confounders, e.g. age and BMI.
Measured: From baseline to 12 weeks (post-intervention)
Secondary outcomes (13)
Change in serum estrone
Similar statistical analysis procedures as described for the primary endpoint will be performed to evaluate the changes of each of the endpoints at a significance level of 5%. Analysis will not be corrected for multiple comparisons but results will be interpreted cautiously. If the data distribution indicates non-normality or skewness, non-parametric tests will be used.
Measured: From baseline to 12 weeks (post-intervention)
Change in serum testosterone
Similar statistical analysis procedures as described for the primary endpoint will be performed to evaluate the changes of each of the endpoints at a significance level of 5%. Analysis will not be corrected for multiple comparisons but results will be interpreted cautiously. If the data distribution indicates non-normality or skewness, non-parametric tests will be used.
Measured: From baseline to 12 weeks (post-intervention)
Change in serum sex hormone-binding globulin (SHBG)
Similar statistical analysis procedures as described for the primary endpoint will be performed to evaluate the changes of each of the endpoints at a significance level of 5%. Analysis will not be corrected for multiple comparisons but results will be interpreted cautiously. If the data distribution indicates non-normality or skewness, non-parametric tests will be used.
Measured: From baseline to 12 weeks (post-intervention)
Change in serum levels of insulin
Similar statistical analysis procedures as described for the primary endpoint will be performed to evaluate the changes of each of the endpoints at a significance level of 5%. Analysis will not be corrected for multiple comparisons but results will be interpreted cautiously. If the data distribution indicates non-normality or skewness, non-parametric tests will be used.
Measured: From baseline to 12 weeks (post-intervention)
Change in serum levels of C-peptide
Similar statistical analysis procedures as described for the primary endpoint will be performed to evaluate the changes of each of the endpoints at a significance level of 5%. Analysis will not be corrected for multiple comparisons but results will be interpreted cautiously. If the data distribution indicates non-normality or skewness, non-parametric tests will be used.
Measured: From baseline to 12 weeks (post-intervention)
Change in serum leptin
Similar statistical analysis procedures as described for the primary endpoint will be performed to evaluate the changes of each of the endpoints at a significance level of 5%. Analysis will not be corrected for multiple comparisons but results will be interpreted cautiously. If the data distribution indicates non-normality or skewness, non-parametric tests will be used.
Measured: From baseline to 12 weeks (post-intervention)
Change in serum adiponectin
Similar statistical analysis procedures as described for the primary endpoint will be performed to evaluate the changes of each of the endpoints at a significance level of 5%. Analysis will not be corrected for multiple comparisons but results will be interpreted cautiously. If the data distribution indicates non-normality or skewness, non-parametric tests will be used.
Measured: From baseline to 12 weeks (post-intervention)
Change in inflammatory markers, measured by serum C-reactive protein
Similar statistical analysis procedures as described for the primary endpoint will be performed to evaluate the changes of each of the endpoints at a significance level of 5%. Analysis will not be corrected for multiple comparisons but results will be interpreted cautiously. If the data distribution indicates non-normality or skewness, non-parametric tests will be used.
Measured: From baseline to 12 weeks (post-intervention)
Change in urinary 8-iso-PGF2alpha
Similar statistical analysis procedures as described for the primary endpoint will be performed to evaluate the changes of each of the endpoints at a significance level of 5%. Analysis will not be corrected for multiple comparisons but results will be interpreted cautiously. If the data distribution indicates non-normality or skewness, non-parametric tests will be used.
Measured: From baseline to 12 weeks (post-intervention)
Change in urinary 8OHdG
Similar statistical analysis procedures as described for the primary endpoint will be performed to evaluate the changes of each of the endpoints at a significance level of 5%. Analysis will not be corrected for multiple comparisons but results will be interpreted cautiously. If the data distribution indicates non-normality or skewness, non-parametric tests will be used.
Measured: From baseline to 12 weeks (post-intervention)
Incidence of reported adverse events
Descriptive statistics of the type and frequency of all adverse events will be generated, including 95% confidence intervals.
Measured: Up to 12 weeks
Incidence of changes in CBC/diff, blood chemistry, and lipids
Measured: Up to 12 weeks
Study agent/metabolite levels
The Spearman correlation coefficient will be calculated to evaluate the correlation between biomarker changes and study agent/metabolite levels. Linear regression techniques will be used to adjust for potential confounders, e.g. age and BMI.
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionJul 2012
- Study completionJul 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 Healthy, no Evidence of DiseaseStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Hsiao-Hui (Sherry) Chow, Principal investigator, University of Arizona Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01370889
- Sponsor's protocol ID
- NCI-2011-02593
- Other IDs
- NCI-2011-02593, CDR0000701405, 10-0653-04, UAZ08-12-01, P30CA023074, N01CN35158
- Status last verified
- Apr 2014
- First submitted
- 9 Jun 2011
- Last updated
- 9 Oct 2014
- Results posted
- No
Publications
Chow HH, Garland LL, Heckman-Stoddard BM, Hsu CH, Butler VD, Cordova CA, Chew WM, Cornelison TL. A pilot clinical study of resveratrol in postmenopausal women with high body mass index: effects on systemic sex steroid hormones. J Transl Med. 2014 Aug 14;12:223. doi: 10.1186/s12967-014-0223-0.
PubMed 25115686
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Resveratrol in Postmenopausal Women With High Body Mass Index
- ClinicalTrials.gov ID
- NCT01370889
- Acronym / sponsor ID
- NCI-2011-02593
- Conditions
- Healthy, no Evidence of Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Jun 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 10 Jun 2011 (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.
This pilot phase I trial studies resveratrol in postmenopausal women with high body mass index. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of resveratrol may keep cancer from forming. Studying samples of blood and urine in the laboratory from postmenopausal women who are taking resveratrol may help doctors learn more about the effects of resveratrol on biomarkers.
Detailed description
PRIMARY OBJECTIVES:
- To determine the effect of pharmacological doses of resveratrol on serum estradiol levels in post-menopausal women with high body mass index (BMI).
SECONDARY OBJECTIVES:
- Assess the effect of resveratrol on serum estrone, testosterone, and sex hormone-binding globulin (SHBP).
II. Assess the effect of resveratrol on serum levels of insulin and C-peptide. III. Assess the effect of resveratrol on adipocytokine expression and secretion as measured by serum leptin and adiponectin.
IV. Assess the effect of resveratrol on inflammatory cytokines as measured by serum C-reactive protein (CRP).
- Assess the effect of resveratrol on oxidative stress as measured by urinary 8-isoprostaglandin F2 alpha (8-iso-PGF2 alpha) and 8-hydroxydeoxyguanosine (8OHdG).
VI. Assess the safety of resveratrol intervention as measured by reported adverse events, complete blood count with differential (CBC/diff), comprehensive metabolic panel (CMP), and lipid profile.
VII. Assess the relationship between systemic study agent exposure and biomarker modulation.
OUTLINE:
Patients receive resveratrol orally (PO) once daily (QD) for 12 weeks.
After completion of study therapy, patients are followed up for 2 weeks
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Basic Science (resveratrol) | Experimental | Drug: resveratrol, Other: laboratory biomarker analysisPatients receive resveratrol PO QD for 12 weeks. |
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Healthy postmenopausal women with a body mass index (BMI) of 25 kg/m^2 or greater
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1; Karnofsky 70% or above
- Leukocytes >= 3,000/uL
- Absolute neutrophil count (ANC) >= 1,500/uL
- Platelets >= 100,000/uL
Key exclusion criteria (17 listed)
- Have had invasive cancer(s) within the past 5 years except non-melanoma skin cancer
- Within 3 months of or concurrent usage of any other investigational agents
- History of allergic reactions attributed to resveratrol
- Unwilling or unable to refrain from taking herbal medicines and dietary supplements
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
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 |
|---|---|---|
| resveratrolGiven PO | Drug | Basic Science (resveratrol) |
| laboratory biomarker analysisCorrelative studies | Other | Basic Science (resveratrol) |
Primary outcome
Change in serum estradiol levels in postmenopausal women with high BMI
Time frame: From baseline to 12 weeks (post-intervention)
A two-sided paired t-test will be performed to determine whether the change is significant at a significance level of 5%. If the data distribution indicates non-normality or skewedness in violation of the assumptions of the t-test, non-parametric tests will be used. Linear regression techniques will be used to adjust for potential confounders, e.g. age and BMI.
13 secondary outcomes
Change in serum estrone
Time frame: From baseline to 12 weeks (post-intervention)
Change in serum testosterone
Time frame: From baseline to 12 weeks (post-intervention)
Change in serum sex hormone-binding globulin (SHBG)
Time frame: From baseline to 12 weeks (post-intervention)
Change in serum levels of insulin
Time frame: From baseline to 12 weeks (post-intervention)
Change in serum levels of C-peptide
Time frame: From baseline to 12 weeks (post-intervention)
Change in serum leptin
Time frame: From baseline to 12 weeks (post-intervention)
Change in serum adiponectin
Time frame: From baseline to 12 weeks (post-intervention)
Change in inflammatory markers, measured by serum C-reactive protein
Time frame: From baseline to 12 weeks (post-intervention)
Change in urinary 8-iso-PGF2alpha
Time frame: From baseline to 12 weeks (post-intervention)
Change in urinary 8OHdG
Time frame: From baseline to 12 weeks (post-intervention)
Incidence of reported adverse events
Time frame: Up to 12 weeks
Incidence of changes in CBC/diff, blood chemistry, and lipids
Time frame: Up to 12 weeks
Study agent/metabolite levels
Time frame: Up to 12 weeks
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 9 Oct 2014.
- Derived from this study: PubMed 25115686Chow HH, Garland LL, Heckman-Stoddard BM, Hsu CH, Butler VD, Cordova CA, Chew WM, Cornelison TL. A pilot clinical study of resveratrol in postmenopausal women with high body mass index: effects on systemic sex steroid hormones. J Transl Med. 2014 Aug 14;12:223. doi: 10.1186/s12967-014-0223-0.
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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.
Hsiao-Hui (Sherry) Chow principal investigator
University of Arizona Health Sciences Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing resveratrol and laboratory biomarker analysis in people with Healthy, no Evidence of Disease, run by National Cancer Institute (NCI) at 2 sites 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?
The sponsor lists 11 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 9 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
Change in serum estradiol levels in postmenopausal women with high BMI (time frame: From baseline to 12 weeks (post-intervention)). 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 NCT01370889, 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 9 Oct 2014.