Clinical trial · Interventional
Brown Seaweed as a Breast Cancer Preventive
NCT01204957CI-TRIAL-00017390completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo and Soy Protein | Dietary Supplement | — | UNRESOLVED |
| Seaweed and Soy Protein | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1 Seaweed and Soy Protein
- description
- Arm 1 5 g/d Seaweed for 6 wk, then 5 g/d Seaweed and Soy Protein for 1 wk
- interventionNames
- Dietary Supplement: Seaweed and Soy Protein
- type
- EXPERIMENTAL
- label
- Arm 2 Placebo and soy protein
- description
- Arm 2 5 g/d Placebo for 6 wk, then 5 g/d Placebo and Soy Protein for 1 wk
- interventionNames
- Dietary Supplement: Placebo and Soy Protein
Primary outcomes (1)
- measure
- Thyroid hormones affected by dietary seaweed and soy supplements
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Postmenopausal (self-reported cessation of menstruation 1 y prior to enrollment) * If breast cancer survivor, all therapy completed at least 6 months prior to enrollment * Agreed to eat their normal diet, avoiding seaweeds and phytoestrogen-rich foods, * Restricting alcoholic intake to #2 drinks (24 g alcohol)/wk -Continuing habitual intake of vitamins, supplements, and medications during the study. - Exclusion Criteria: * No allergies to seaweed, soy, shellfish, or iodine * No current use of tobacco; * No thyroid dysfunction or treatment within the previous 5 y; * Negative thyroid peroxidase antibodies as determined by screening; * No hormone replacement therapy or for breast cancer survivors, no chemotherapy or radiation treatments within the preceding 6 mo * No history of cancer (other than breast cancer) * No current gastrointestinal disorders or diabetes; omnivorous eating habits, including meat and dairy products at least twice/wk * No oral antibiotics, iodine containing medications, or corticosteroids treatment within the previous 3 mo.
References
Publications (3)
- RESULTTeas J, Hurley TG, Hebert JR, Franke AA, Sepkovic DW, Kurzer MS. Dietary seaweed modifies estrogen and phytoestrogen metabolism in healthy postmenopausal women. J Nutr. 2009 May;139(5):939-44. doi: 10.3945/jn.108.100834. Epub 2009 Mar 25. PMID 19321575
- RESULTTeas J, Braverman LE, Kurzer MS, Pino S, Hurley TG, Hebert JR. Seaweed and soy: companion foods in Asian cuisine and their effects on thyroid function in American women. J Med Food. 2007 Mar;10(1):90-100. doi: 10.1089/jmf.2005.056. PMID 17472472
- RESULTTeas J, Pino S, Critchley A, Braverman LE. Variability of iodine content in common commercially available edible seaweeds. Thyroid. 2004 Oct;14(10):836-41. doi: 10.1089/thy.2004.14.836. PMID 15588380