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T05029: A double blind placebo controlled crossover trial of soy phytoestrogens in patients with compensated hypothyroidism

Friday 12 November 2004

This research project will determine if two different soya preparations have an effect on subjects with compensated hypothyroidism.

Study Duration : January 2005 to July 2006

Contractor : University of Hull

Background

It has been shown that soya phytoestrogens affect thyroid function in both animals and in human studies. The significant changes in thyroid function reported have been considered too small in magnitude to be physiologically important in subjects with normal thyroid function. However, the effect of soya consumption in patients whose thyroid function is already compromised may be clinically important.

Research Approach

Subjects with compensated hypothyroidism will be given either a soya protein preparation that is isoflavone free or a preparation with a known concentration of soya isoflavones. Clinical effects and any changes to thyroid status will be determined by analysis of blood and urine biochemistry. This will be achieved by a cross over, double blind, placebo controlled trial involving 134 patients. This research will confirm whether soya may be clinically important in patients with compromised thyroid function.

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