Trial | NCT01204957  Report issue

Official Title

Brown Seaweed as a Breast Cancer Preventive

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    seaweed soybean ...

  • Study Participants

    33
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.
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.
Study Started
Oct 31
1998
Primary Completion
Mar 31
1999
Study Completion
Mar 31
1999
Last Update
Apr 06
2015
Estimate

Dietary Supplement Seaweed and Soy Protein

5 g/d Seaweed for 6 wks, followed by 5 g/d Seaweed + Soy Protein for 1 wk

  • Other names: Solae Soy Food Ingredient Powder (AB1.2 HG 20CA 29), Alaria esculenta

Dietary Supplement Placebo and Soy Protein

5 g/d Placebo for 6 wks, followed by 5 g/d Placebo + Soy Protein for 1 wk

  • Other names: Solae Nutritious Food Ingredient Powder (AB1.2 HG 20CA 29), Maltrin M100 maltodextrin (Grain Processing)

Arm 1 Seaweed and Soy Protein Experimental

Arm 1 5 g/d Seaweed for 6 wk, then 5 g/d Seaweed and Soy Protein for 1 wk

Arm 2 Placebo and soy protein Experimental

Arm 2 5 g/d Placebo for 6 wk, then 5 g/d Placebo and Soy Protein for 1 wk

Criteria 

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.
No Results Posted