Brown Seaweed as a Breast Cancer Preventive

April 2, 2015 updated by: Jane Teas, University of South Carolina
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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
Experimental: 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
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
14 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
14 wks
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
14 wks
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
14 wk

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Carolina

Collaborators

Susan G. Komen Breast Cancer Foundation

Investigators

  • Study Director: Jane Teas, Ph.D., University of South Carolina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1998

Primary Completion (Actual)

March 1, 1999

Study Completion (Actual)

March 1, 1999

Study Registration Dates

First Submitted

September 16, 2010

First Submitted That Met QC Criteria

September 16, 2010

First Posted (Estimate)

September 17, 2010

Study Record Updates

Last Update Posted (Estimate)

April 6, 2015

Last Update Submitted That Met QC Criteria

April 2, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USCIRB#060701

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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