Brown Seaweed as a Breast Cancer Preventive

Breast Cancer Clinical Trial

Official title:

Brown Seaweed as a Breast Cancer Preventive

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01204957
• Other study ID #: USCIRB#060701
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 16, 2010
• Last updated: April 2, 2015
• Start date: October 1998
• Est. completion date: March 1999

Study information

• Verified date: April 2015
• Source: University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: March 1999
• Est. primary completion date: March 1999
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Dietary Supplement:
• Seaweed and Soy Protein
5 g/d Seaweed for 6 wks, followed by 5 g/d Seaweed + Soy Protein for 1 wk
• Placebo and Soy Protein
5 g/d Placebo for 6 wks, followed by 5 g/d Placebo + Soy Protein for 1 wk

Locations

Country	Name	City	State
United States	University of Massachusetts	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
University of South Carolina	Susan G. Komen Breast Cancer Foundation

Country where clinical trial is conducted

United States, 

References & Publications (3)

Teas 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. — View Citation

Teas 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. Erratum in: J Nu — View Citation

Teas J, Pino S, Critchley A, Braverman LE. Variability of iodine content in common commercially available edible seaweeds. Thyroid. 2004 Oct;14(10):836-41. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thyroid hormones affected by dietary seaweed and soy supplements	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	14 weeks	Yes
Secondary	Serum estrogen and urinary phytoestrogen concentrations affected by seaweed and soy	6 wk seaweed then 1 wk seaweed plus soy; OR 6 wk placebo then 1 wk soy 3 wk washout period, then crossover to alternate arm	14 wks	No
Secondary	Serum antioxidant and homocysteine concentrations associated with seaweed and soy	6 wks 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	14 wks	No
Secondary	Serum IGF-1 and IGFBP3 changes associated with seaweed and soy supplementation	6 wk seaweed then 1 wk seaweed plus soy OR 6 wk placebo then 1 wk soy plus placebo 3 wk washout then crossover to alternate arm	14 wk	No