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Completed

NCT Number: NCT01204957

Brown Seaweed as a Breast Cancer Preventive

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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Key information

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Massachusetts

Worcester, Massachusetts, 01655, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Seaweed and Soy Protein

Dietary Supplement

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

Placebo and Soy Protein

Dietary Supplement

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)

Primary outcomes

  1. Thyroid hormones affected by dietary seaweed and soy supplements

    Time frame: 14 weeks

    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

Secondary outcomes

  1. Serum estrogen and urinary phytoestrogen concentrations affected by seaweed and soy

    Time frame: 14 wks

    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

  2. Serum antioxidant and homocysteine concentrations associated with seaweed and soy

    Time frame: 14 wks

    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

  3. Serum IGF-1 and IGFBP3 changes associated with seaweed and soy supplementation

    Time frame: 14 wk

    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

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Collaborators

  • Susan G. Komen Breast Cancer Foundation

Registry information

Important dates

Study start
1998
Primary completion
1999
Study completion
1999
First posted
Sep 17, 2010
Registry last updated
Apr 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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