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Dietary Seaweed and Early Breast Cancer: A Randomized Trial

This study has been completed.
Sponsor:
Collaborator:
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
University of South Carolina
ClinicalTrials.gov Identifier:
NCT01663792
First received: August 9, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
  Purpose

Could daily consumption of seaweed help explain lower postmenopausal breast cancer (BC) incidence and mortality rates in Japan? This small proof of principle clinical trial was designed to test the idea that the same amount of seaweed normally eaten in Japan would induce metabolic changes when given to non-seaweed consuming healthy postmenopausal American women. The participants were given 10 capsules a day (about 1 tablespoon) for 3 months. During the first month the capsules contained placebo, the second month seaweed, and the third month placebo. We collected blood and urine samples after each treatment period and tested for changes in protein expression that might be related to consuming seaweed.


Condition Intervention
Seaweed Associated Changes in Healthy Subjects
 Other: Seaweed

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Dietary Seaweed and Early Breast Cancer: A Randomized Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of South Carolina:

Primary Outcome Measures:
  • Urinary urokinase receptor concentration [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    ELISA test for uPAR concentration

  • Surface Enhanced Laser Desorption/Ionization-Time Of Flight-Mass Spectrometry (SELDI-TOF-MS)identification of urinary and serum protein changes [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    SELDI-TOF-MS was used to measure urinary and serum protein changes


Secondary Outcome Measures:
  • Urinary iodine concentrations [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Urinary iodine concentration changes were used to indicate adherence to taking the seaweed supplement.


Enrollment: 15
Study Start Date: October 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
5 g/d placebo (maltodextrin)in 10 500-mg capsules for 1 month
Experimental: Seaweed
Seaweed (Undaria pinnatifida) given orally in ten 500-mg capsules for 1 month
 Other: Seaweed
Ten 500-mg capsules to be taken orally each day for 1 month
Other Name: Undaria pinnatifida
Placebo Comparator: Placebo2
5 g/d placebo in 10 500-mg capsules for one month

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   45 Years to 68 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy
  • Postmenopausal (verified by follicle stimulating hormone (FSH) [23.0-116 mIU/ml]
  • Omnivorous eating habits (including meat and dairy products more than twice per week)
  • Limit alcoholic intake to ≤ 1 drink (12 g alcohol)/week

Exclusion Criteria:

  • No allergies to seaweed, soy, shellfish or iodine
  • No current use of tobacco
  • No hormone replacement therapy
  • For BC survivors, no chemotherapy or radiation treatments within the preceding 6 months
  • No history of cancer (other than BC or squamous cell skin cancer) within the previous 20 years
  • No current gastrointestinal disorders or diabetes
  • No oral antibiotics taken in the previous 3 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01663792

Locations
United States, South Carolina
University of South Carolina Cancer Research Center
Columbia, South Carolina, United States, 29208
Sponsors and Collaborators
University of South Carolina
U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: Jane Teas, Ph.D. University of South Carolina
  More Information

Publications:

Responsible Party: University of South Carolina
ClinicalTrials.gov Identifier: NCT01663792     History of Changes
Other Study ID Numbers: DAMD-17-98-1-8207
Study First Received: August 9, 2012
Last Updated: August 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of South Carolina:
urokinase receptor
protein expression
seaweed (Undaria pinnatifida)

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

ClinicalTrials.gov processed this record on May 16, 2013