Brown Seaweed as a Breast Cancer Preventive
Primary Purpose
Breast Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Seaweed and Soy Protein
Placebo and Soy Protein
Sponsored by
About this trial
This is an interventional prevention trial for Breast Cancer focused on measuring Homocysteine, Insulin-like growth factor, Insulin-like growth factor binding protein, Serum estrogen, Urinary phytoestrogens, Thyroid hormones
Eligibility 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.
Sites / Locations
- University of Massachusetts
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm 1 Seaweed and Soy Protein
Arm 2 Placebo and soy protein
Arm Description
Arm 1 5 g/d Seaweed for 6 wk, then 5 g/d Seaweed and Soy Protein for 1 wk
Arm 2 5 g/d Placebo for 6 wk, then 5 g/d Placebo and Soy Protein for 1 wk
Outcomes
Primary Outcome Measures
Thyroid hormones affected by dietary seaweed and soy supplements
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
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
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
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
Full Information
NCT ID
NCT01204957
First Posted
September 16, 2010
Last Updated
April 2, 2015
Sponsor
University of South Carolina
Collaborators
Susan G. Komen Breast Cancer Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01204957
Brief Title
Brown Seaweed as a Breast Cancer Preventive
Official Title
Brown Seaweed as a Breast Cancer Preventive
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
October 1998 (undefined)
Primary Completion Date
March 1999 (Actual)
Study Completion Date
March 1999 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Carolina
Collaborators
Susan G. Komen Breast Cancer Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Homocysteine, Insulin-like growth factor, Insulin-like growth factor binding protein, Serum estrogen, Urinary phytoestrogens, Thyroid hormones
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1 Seaweed and Soy Protein
Arm Type
Experimental
Arm Description
Arm 1 5 g/d Seaweed for 6 wk, then 5 g/d Seaweed and Soy Protein for 1 wk
Arm Title
Arm 2 Placebo and soy protein
Arm Type
Experimental
Arm Description
Arm 2 5 g/d Placebo for 6 wk, then 5 g/d Placebo and Soy Protein for 1 wk
Intervention Type
Dietary Supplement
Intervention Name(s)
Seaweed and Soy Protein
Other Intervention Name(s)
Solae Soy Food Ingredient Powder (AB1.2 HG 20CA 29), Alaria esculenta
Intervention Description
5 g/d Seaweed for 6 wks, followed by 5 g/d Seaweed + Soy Protein for 1 wk
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo and Soy Protein
Other Intervention Name(s)
Solae Nutritious Food Ingredient Powder (AB1.2 HG 20CA 29), Maltrin M100 maltodextrin (Grain Processing)
Intervention Description
5 g/d Placebo for 6 wks, followed by 5 g/d Placebo + Soy Protein for 1 wk
Primary Outcome Measure Information:
Title
Thyroid hormones affected by dietary seaweed and soy supplements
Description
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
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
Serum estrogen and urinary phytoestrogen concentrations affected by seaweed and soy
Description
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
Time Frame
14 wks
Title
Serum antioxidant and homocysteine concentrations associated with seaweed and soy
Description
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
Time Frame
14 wks
Title
Serum IGF-1 and IGFBP3 changes associated with seaweed and soy supplementation
Description
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
Time Frame
14 wk
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jane Teas, Ph.D.
Organizational Affiliation
University of South Carolina
Official's Role
Study Director
Facility Information:
Facility Name
University of Massachusetts
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19321575
Citation
Teas J, Hurley TG, Hebert JR, Franke AA, Sepkovic DW, Kurzer MS. Dietary seaweed modifies estrogen and phytoestrogen metabolism in healthy postmenopausal women. J Nutr. 2009 May;139(5):939-44. doi: 10.3945/jn.108.100834. Epub 2009 Mar 25. Erratum In: J Nutr. 2009 Sep;139(9):1779.
Results Reference
result
PubMed Identifier
17472472
Citation
Teas J, Braverman LE, Kurzer MS, Pino S, Hurley TG, Hebert JR. Seaweed and soy: companion foods in Asian cuisine and their effects on thyroid function in American women. J Med Food. 2007 Mar;10(1):90-100. doi: 10.1089/jmf.2005.056.
Results Reference
result
PubMed Identifier
15588380
Citation
Teas J, Pino S, Critchley A, Braverman LE. Variability of iodine content in common commercially available edible seaweeds. Thyroid. 2004 Oct;14(10):836-41. doi: 10.1089/thy.2004.14.836.
Results Reference
result
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Brown Seaweed as a Breast Cancer Preventive
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