Breast CancerPhase 1/2NCT01204957
Brown Seaweed as a Breast Cancer Preventive
A Phase 1/2 study testing Seaweed and Soy Protein in people with Breast Cancer, run by University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Seaweed and Soy Protein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 1998to Mar 1999
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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. -
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts
Worcester, Massachusetts, 01655
About this study
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Seaweed and Soy Protein, Placebo and Soy Protein
- Keywords
- Homocysteine, Insulin-like growth factor, Insulin-like growth factor binding protein, Serum estrogen, Urinary phytoestrogens, Thyroid hormones
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seaweed and Soy ProteinDietary supplement
Also called Solae Soy Food Ingredient Powder (AB1.2 HG 20CA 29), Alaria esculenta
5 g/d Seaweed for 6 wks, followed by 5 g/d Seaweed + Soy Protein for 1 wk
Placebo and Soy ProteinDietary supplement
Also called Solae Nutritious Food Ingredient Powder (AB1.2 HG 20CA 29), Maltrin M100 maltodextrin (Grain Processing)
5 g/d Placebo for 6 wks, followed by 5 g/d Placebo + Soy Protein for 1 wk
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 Seaweed and Soy Protein | Experimental | Arm 1 5 g/d Seaweed for 6 wk, then 5 g/d Seaweed and Soy Protein for 1 wk Receives: Dietary Supplement: Seaweed and Soy Protein |
| Arm 2 Placebo and soy protein | Experimental | Arm 2 5 g/d Placebo for 6 wk, then 5 g/d Placebo and Soy Protein for 1 wk Receives: Dietary Supplement: Placebo and Soy Protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 14 weeks
Secondary outcomes (3)
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
Measured: 14 wks
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
Measured: 14 wks
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
Measured: 14 wk
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2010 (estimated)
- Study startOct 1998
- Primary completionMar 1999
- Study completionMar 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Susan G. Komen Breast Cancer Foundation
- Responsible party
- Principal investigator, Jane Teas, University of South Carolina
- Investigators
- Jane Teas, Ph.D., Study director, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01204957
- Sponsor's protocol ID
- USCIRB#060701
- Status last verified
- Apr 2015
- First submitted
- 16 Sep 2010
- Last updated
- 6 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19321575Teas 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.
PubMed 17472472Teas 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.
PubMed 15588380
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brown Seaweed as a Breast Cancer Preventive
- ClinicalTrials.gov ID
- NCT01204957
- Acronym / sponsor ID
- USCIRB#060701
- Conditions
- Breast Cancer
- Keywords
- Homocysteine, Insulin-like growth factor, Insulin-like growth factor binding protein, Serum estrogen, Urinary phytoestrogens, Thyroid hormones
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- Susan G. Komen Breast Cancer Foundation
- Study start
- Oct 1998
- Primary completion
- Mar 1999 (actual)
- Study completion
- Mar 1999 (actual)
- First posted
- 17 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 Seaweed and Soy Protein | Experimental | Dietary Supplement: Seaweed and Soy ProteinArm 1 5 g/d Seaweed for 6 wk, then 5 g/d Seaweed and Soy Protein for 1 wk |
| Arm 2 Placebo and soy protein | Experimental | Dietary Supplement: Placebo and Soy ProteinArm 2 5 g/d Placebo for 6 wk, then 5 g/d Placebo and Soy Protein for 1 wk |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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. -
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Seaweed and Soy ProteinAlso: Solae Soy Food Ingredient Powder (AB1.2 HG 20CA 29), Alaria esculenta5 g/d Seaweed for 6 wks, followed by 5 g/d Seaweed + Soy Protein for 1 wk | Dietary supplement | Arm 1 Seaweed and Soy Protein |
| Placebo and Soy ProteinAlso: Solae Nutritious Food Ingredient Powder (AB1.2 HG 20CA 29), Maltrin M100 maltodextrin (Grain Processing)5 g/d Placebo for 6 wks, followed by 5 g/d Placebo + Soy Protein for 1 wk | Dietary supplement | Arm 2 Placebo and soy protein |
Primary outcome
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
3 secondary outcomes
Serum estrogen and urinary phytoestrogen concentrations affected by seaweed and soy
Time frame: 14 wks
Serum antioxidant and homocysteine concentrations associated with seaweed and soy
Time frame: 14 wks
Serum IGF-1 and IGFBP3 changes associated with seaweed and soy supplementation
Time frame: 14 wk
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2015.
- Results publication: PubMed 19321575Teas 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.
- Results publication: PubMed 17472472Teas 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 publication: PubMed 15588380Teas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane Teas, Ph.D. study director
University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Seaweed and Soy Protein in people with Breast Cancer, run by University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thyroid hormones affected by dietary seaweed and soy supplements (time frame: 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01204957, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2015.