Dietary Seaweed and Early Breast Cancer: A Randomized Trial

Completed · Not applicable · Has a placebo group

Conditions studied: Seaweed Associated Changes in Healthy Subjects

In brief

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.

Key facts

Study ID

NCT01663792

Run by

University of South Carolina

People needed

15

Starts

2006-10-01

Expected to finish

2007-12-01

Last updated by the study team

2021-05-11

Who can join

Age: 45 and older, up to 68. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of South Carolina Cancer Research Center — Columbia, South Carolina, United States

Full record on ClinicalTrials.gov

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