Effect of Soy Intake on Cardiovascular Disease Biomarkers in Subclinical Hypothyroid Participants
| Status: | Withdrawn |
|---|---|
| Conditions: | Peripheral Vascular Disease, Endocrine |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology |
| Healthy: | No |
| Age Range: | 25 - 70 |
| Updated: | 4/21/2016 |
| Start Date: | February 2015 |
| End Date: | September 2015 |
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.
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.
subclinical hypothyroidism will be randomized to consume either soy protein isolate or milk
protein isolate for 8 weeks.
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
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