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Dietary Seaweed and Early Breast Cancer: A Randomized Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01663792
First Posted: August 13, 2012
Last Update Posted: January 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
University of South Carolina
  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 Other: Placebo Other: Placebo2

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

Resource links provided by NLM:


Further study details as provided by University of South Carolina:

Primary Outcome Measures:
  • Urinary urokinase receptor concentration [ Time Frame: 3 months ]
    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 ]
    SELDI-TOF-MS was used to measure urinary and serum protein changes


Secondary Outcome Measures:
  • Urinary iodine concentrations [ Time Frame: 3 months ]
    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
Other: Placebo
Ten 500-mg capsules to be taken orally each day for 1 month
Other Name: Maltodextrin
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
Other: Placebo2
Ten 500-mg capsules to be taken orally each day for 1 month
Other Name: Maltodextrin

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 68 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: August 9, 2012
First Posted: August 13, 2012
Last Update Posted: January 15, 2016
Last Verified: January 2016

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