Effect of Soy Intake on Cardiovascular Disease Biomarkers in Subclinical Hypothyroid Participants

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Soy Intake on Cardiovascular Disease Biomarkers in Subclinical Hypothyroid Participants

Conditions
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Cardiovascular Disease, Subclinical Hypothyroid

Intervention / Treatment
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* Dietary Supplement: soy protein isolate (SPI)
* Dietary Supplement: milk protein isolate (MPI)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: soy protein isolate (SPI)<br>25 grams soy protein isolate (SPI) containing approximately 30 mg/d isoflavones | Dietary Supplement: soy protein isolate (SPI)<br> <br> |
| Active Comparator: milk protein isolate (MPI)<br>milk protein isolate (MPI) containing 0 mg/d isoflavones | Dietary Supplement: milk protein isolate (MPI)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the cardiometabolic profile | Evaluate the role of isoflavone intake on cardiovascular disease. | Change from Baseline to Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in thyroid function | Safety will be monitored through measuring thyroid stimulating hormone (TSH) and free thyroxine (T4) in participants while on the study. | Change from Basesline to 8 Weeks | 
| Change in thyroid function | Safety will be monitored through measuring thyroid stimulating hormone (TSH) and free thyroxine (T4) in participants while on the study. | Change from Basesline to 4 Weeks | 
| Changes in the cardiometabolic profile | Evaluate the role of isoflavone intake on cardiovascular disease. | Change from Basesline to 4 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CVD, isoflavone, soy intake, subclinical hypothyroid