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

September 16, 2010
September 16, 2010
October 1998
March 1999   (final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
  • 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
Same as current
Not Provided
Not Provided
 
Brown Seaweed as a Breast Cancer Preventive
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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Breast Cancer
  • Thyroid Hormones
  • 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)
  • 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)
  • Experimental: Arm 1: seaweed and soy
    5 g/d seaweed for 6 wk, then 5 g/d seaweed plus soy supplement for 1 wk
    Intervention: Dietary Supplement: Alaria esculenta, soy protein isolate
  • Experimental: Arm 2 Placebo, soy
    6 wk placebo (10 maltodextrin 5 g/d capsules), followed by 1 wk of placebo capsules and soy powder
    Intervention: Dietary Supplement: Soy protein isolate, placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
March 1999
March 1999   (final data collection date for primary outcome measure)

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.
Female
18 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01204957
USCIRB#060701
No
Jane Teas/Research Assistant Professor, University of South Carolina Research Foundation
University of South Carolina
Susan G. Komen Breast Cancer Foundation
Study Director: Jane Teas, Ph.D. University of South Carolina
University of South Carolina
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP