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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR000001 | U.S. NIH Grant/Contract | View source | |
| HD002528 | Other Identifier | Kansas Intellectual and Developmental Disabilities Research Center |
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| Name | Class |
|---|---|
| Soy Nutrition Institute | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| soy protein isolate (SPI) | Experimental | 25 grams soy protein isolate (SPI) containing approximately 30 mg/d isoflavones |
|
| milk protein isolate (MPI) | Active Comparator | milk protein isolate (MPI) containing 0 mg/d isoflavones |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| soy protein isolate (SPI) | Dietary Supplement |
| ||
| milk protein isolate (MPI) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the cardiometabolic profile | Evaluate the role of isoflavone intake on cardiovascular disease. | Change from Baseline to Week 8 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jill Hamilton-Reeves, PhD, RD, LD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D030262 | Soybean Proteins |
| ID | Term |
|---|---|
| D010940 | Plant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014674 | Plant Proteins, Dietary |
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| Dietary Supplement |
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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 |
| D004044 |
| Dietary Proteins |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D045730 | Soy Foods |
| D000067075 | Vegetable Products |
| D014675 | Vegetables |
| D019602 | Food and Beverages |