Cardiovascular Disease, Subclinical Hypothyroid
Conditions
Keywords
isoflavone, CVD, soy intake, subclinical hypothyroid
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTsoy protein isolate (SPI)
DIETARY_SUPPLEMENTmilk protein isolate (MPI)
Sponsors
Soy Nutrition Institute
Jill Hamilton-Reeves, PhD RD LD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the cardiometabolic profile | Change from Baseline to Week 8 | Evaluate the role of isoflavone intake on cardiovascular disease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in thyroid function | Change from Basesline to 8 Weeks | Safety will be monitored through measuring thyroid stimulating hormone (TSH) and free thyroxine (T4) in participants while on the study. |
| Changes in the cardiometabolic profile | Change from Basesline to 4 Weeks | Evaluate the role of isoflavone intake on cardiovascular disease. |
Countries
United States
Outcome results
None listed