Brown Seaweed as a Breast Cancer Preventive

NCT01204957 | Completed Phase 1

• 1 other identifier: USCIRB#060701
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Homocysteine; Insulin-like growth factor; Insulin-like growth factor binding protein; Serum estrogen; Urinary phytoestrogens; Thyroid hormones

Outcome Measures

Primary Outcomes (1)

• 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

  14 weeks

Secondary Outcomes (3)

• Serum estrogen and urinary phytoestrogen concentrations affected by seaweed and soy

  14 wks

• Serum antioxidant and homocysteine concentrations associated with seaweed and soy

  14 wks

• Serum IGF-1 and IGFBP3 changes associated with seaweed and soy supplementation

  14 wk

Study Arms (2)

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

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

Dietary Supplement: Placebo and Soy Protein

Interventions

Seaweed and Soy Protein DIETARY_SUPPLEMENT

5 g/d Seaweed for 6 wks, followed by 5 g/d Seaweed + Soy Protein for 1 wk

Also known as: Solae Soy Food Ingredient Powder (AB1.2 HG 20CA 29), Alaria esculenta

Arm 1 Seaweed and Soy Protein

Placebo and Soy Protein DIETARY_SUPPLEMENT

5 g/d Placebo for 6 wks, followed by 5 g/d Placebo + Soy Protein for 1 wk

Also known as: Solae Nutritious Food Ingredient Powder (AB1.2 HG 20CA 29), Maltrin M100 maltodextrin (Grain Processing)

Arm 2 Placebo and soy protein

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. -

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of South Carolina: lead
• Susan G. Komen Breast Cancer Foundation: collaborator

Study Sites (1)

University of Massachusetts

Worcester, Massachusetts, 01655, United States

Location

Related Publications (3)

• 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.

  PMID: 19321575 RESULT

• 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.

  PMID: 17472472 RESULT

• 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.

  PMID: 15588380 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Soybean Proteins

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Plant Proteins, Dietary; Dietary Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Soy Foods; Vegetable Products; Vegetables; Food and Beverages

Study Officials

• Jane Teas, Ph.D.

  University of South Carolina

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 16, 2010
• First Posted: September 17, 2010
• Study Start: October 1, 1998
• Primary Completion: March 1, 1999
• Study Completion: March 1, 1999
• Last Updated: April 6, 2015

Record last verified: 2015-04

Locations

US (1)