Trial | NCT02024906  Report issue

Official Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Withdrawn

  • Intervention/Treatment

    soybean ...

  • Study Participants

    0
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.
Study Started
Feb 28
2015
Primary Completion
Sep 30
2015
Study Completion
Sep 30
2015
Last Update
Sep 23
2015
Estimate

Dietary Supplement soy protein isolate (SPI)

Dietary Supplement milk protein isolate (MPI)

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

Criteria 

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
No Results Posted