Effect of Soy Intake on Cardiovascular Disease Biomarkers in Subclinical Hypothyroid Participants
Lead SponsorUniversity of Kansas
Indication/ConditionCardiovascular Disease Subclinical Hypothyroid
Intervention/Treatmentsoy protein ...
The purpose of this study is to help the researchers understand if using a soy supplement impacts cardiovascular disease risk factors in patients with subclinical hypothyroidism.
This pilot trial is a double blind, randomized, parallel arm trial. Eighty participants with subclinical hypothyroidism will be randomized to consume either soy protein isolate or milk protein isolate for 8 weeks.
25 grams soy protein isolate (SPI) containing approximately 30 mg/d isoflavones
milk protein isolate (MPI) containing 0 mg/d isoflavones
Inclusion Criteria: Patients with subclinical hypothyroidism (otherwise healthy volunteers) Adults aged 25 - 70 yrs. Willing to avoid consumption of soy/other isoflavone containing foods (i.e. some snack bars) during the study. Willing to avoid consumption of dietary (other than multivitamin) and herbal supplements during the study. Exclusion Criteria: Taking drugs that interfere with thyroid function Planning pregnancy in the next 6 months Taking drugs that lower lipids, blood pressure, or sensitize insulin Regular consumption of soy products (>20 g/wk) Consumption of soyfoods within 90 days prior to enrollment. Known history of soy or milk allergy or intolerance. Taking antibiotics during the intervention Active viral infections such as Human immunodeficiency virus (HIV) positive or hepatitis