Brown Seaweed as a Breast Cancer Preventive

This study has been completed.
Sponsor:
Collaborator:
Susan G. Komen Breast Cancer Foundation
Information provided by:
University of South Carolina
ClinicalTrials.gov Identifier:
NCT01204957
First received: September 16, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Thyroid Hormones
Dietary Supplement: Alaria esculenta, soy protein isolate
Dietary Supplement: Soy protein isolate, placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Brown Seaweed as a Breast Cancer Preventive

Resource links provided by NLM:


Further study details as provided by University of South Carolina:

Primary Outcome Measures:
  • Thyroid hormones affected by dietary seaweed and soy supplements [ Time Frame: 14 weeks ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Serum estrogen and urinary phytoestrogen concentrations affected by seaweed and soy [ Time Frame: 14 wks ] [ Designated as safety issue: No ]
    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

  • Serum antioxidant and homocysteine concentrations associated with seaweed and soy [ Time Frame: 14 wks ] [ Designated as safety issue: No ]
    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

  • Serum IGF-1 and IGFBP3 changes associated with seaweed and soy supplementation [ Time Frame: 14 wk ] [ Designated as safety issue: No ]
    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


Enrollment: 33
Study Start Date: October 1998
Study Completion Date: March 1999
Primary Completion Date: March 1999 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: seaweed and soy
5 g/d seaweed for 6 wk, then 5 g/d seaweed plus soy supplement for 1 wk
Dietary Supplement: Alaria esculenta, soy protein isolate
5 g/d Alaria esculenta, given in pills to be taken in the evening for 6 wks Soy protein isolate powder (2 mg/kg body wt)given during the 7th wk with Alaria
Other Name: Solae Soy Food Ingredient Powder (AB1.2 HG 20CA 29)
Experimental: Arm 2 Placebo, soy
6 wk placebo (10 maltodextrin 5 g/d capsules), followed by 1 wk of placebo capsules and soy powder
Dietary Supplement: Soy protein isolate, placebo
Placebo (10 capsules/d of maltodextrin to be taken in the evening for 7 wks) followed by 1 wk placebo capsules plus soy protein isolate powder, to be taken once a day in the evening
Other Names:
  • Solae Nutritious Food Ingredient Powder (AB1.2 HG 20CA 29)
  • Maltrin M100 maltodextrin (Grain Processing)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01204957

Locations
United States, Massachusetts
University of Massachusetts
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
University of South Carolina
Susan G. Komen Breast Cancer Foundation
Investigators
Study Director: Jane Teas, Ph.D. University of South Carolina
  More Information

Publications:
Responsible Party: Jane Teas/Research Assistant Professor, University of South Carolina Research Foundation
ClinicalTrials.gov Identifier: NCT01204957     History of Changes
Other Study ID Numbers: USCIRB#060701
Study First Received: September 16, 2010
Last Updated: September 16, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of South Carolina:
Homocysteine
Insulin-like growth factor
Insulin-like growth factor binding protein
Serum estrogen
Urinary phytoestrogens
Thyroid hormones

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 23, 2014