Brown Seaweed as a Breast Cancer Preventive

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-10-31

Study Completion Date

1999-03-31

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arm 1 Seaweed and Soy Protein

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

Group Type EXPERIMENTAL

Seaweed and Soy Protein

Intervention Type DIETARY_SUPPLEMENT

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

Arm 2 Placebo and soy protein

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

Group Type EXPERIMENTAL

Placebo and Soy Protein

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Seaweed and Soy Protein

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

Intervention Type DIETARY_SUPPLEMENT

Placebo and Soy Protein

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Solae Soy Food Ingredient Powder (AB1.2 HG 20CA 29) Alaria esculenta Solae Nutritious Food Ingredient Powder (AB1.2 HG 20CA 29) Maltrin M100 maltodextrin (Grain Processing)

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes