Brown Seaweed as a Breast Cancer Preventive
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| First Received Date ICMJE | September 16, 2010 | ||||
| Last Updated Date | September 16, 2010 | ||||
| Start Date ICMJE | October 1998 | ||||
| Primary Completion Date | March 1999 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Thyroid hormones affected by dietary seaweed and soy supplements [ Time Frame: 14 weeks ] [ Designated as safety issue: Yes ] 6 wk seaweed followed by 1 wk seaweed plus soy; Or 6 wk placebo followed by 1 wk soy 3 wk washout period then crossover to alternate arm |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Brown Seaweed as a Breast Cancer Preventive | ||||
| Official Title ICMJE | Brown Seaweed as a Breast Cancer Preventive | ||||
| Brief Summary | Japanese postmenopausal women in Japan have about one ninth the rate of American postmenopausal women. Rates of breast cancer double even after just ten years among Japanese women who migrate to the US. Diet is thought to be an important factor, and the investigators were interested in whether dietary seaweed, with and without soy supplements, could influence known biomarkers of breast cancer risk in American women. |
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| Detailed Description | 33 healthy postmenopausal women were randomized to 6 wk seaweed then 1 wk seaweed plus soy or 6 wk placebo then 1 wk placebo plus soy. Blood and urine samples were collected at the end of each treatment period and analyzed for estrogen, homocysteine, antioxidants, insulin-like growth factors and thyroid hormones. Urine was analyzed for phytoestrogens and iodine. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 Phase 2 |
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| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 33 | ||||
| Completion Date | March 1999 | ||||
| Primary Completion Date | March 1999 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 80 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01204957 | ||||
| Other Study ID Numbers ICMJE | USCIRB#060701 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Jane Teas/Research Assistant Professor, University of South Carolina Research Foundation | ||||
| Study Sponsor ICMJE | University of South Carolina | ||||
| Collaborators ICMJE | Susan G. Komen Breast Cancer Foundation | ||||
| Investigators ICMJE |
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| Information Provided By | University of South Carolina | ||||
| Verification Date | September 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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