Dietary Seaweed and Early Breast Cancer: A Randomized Trial

NCT01663792 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2021-05-11

No results posted yet for this study

Summary

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.

Conditions

  • Seaweed Associated Changes in Healthy Subjects

Interventions

OTHER

Seaweed

Ten 500-mg capsules to be taken orally each day for 1 month

OTHER

Placebo

Ten 500-mg capsules to be taken orally each day for 1 month

OTHER

Placebo2

Ten 500-mg capsules to be taken orally each day for 1 month

Sponsors & Collaborators

  • U.S. Army Medical Research and Development Command

    collaborator FED
  • University of South Carolina

    lead OTHER

Principal Investigators

  • Jane Teas, Ph.D. · University of South Carolina

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
45 Years
Max Age
68 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2007-12-31
Completion
2007-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01663792 on ClinicalTrials.gov