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

Jill Hamilton-Reeves, PhD RD LD

Status

Withdrawn

Conditions

Subclinical Hypothyroid

Cardiovascular Disease

Treatments

Dietary Supplement: milk protein isolate (MPI)

Dietary Supplement: soy protein isolate (SPI)

Study type

Interventional

Funder types

Other

Identifiers

NCT02024906

STUDY00000073

UL1TR000001 (U.S. NIH Grant/Contract)

HD002528 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

25 to 70 years old

Volunteers

No Healthy Volunteers

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