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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2015-09-30

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.

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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.

Conditions

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Cardiovascular Disease Subclinical Hypothyroid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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soy protein isolate (SPI)

25 grams soy protein isolate (SPI) containing approximately 30 mg/d isoflavones

Group Type EXPERIMENTAL

soy protein isolate (SPI)

Intervention Type DIETARY_SUPPLEMENT

milk protein isolate (MPI)

milk protein isolate (MPI) containing 0 mg/d isoflavones

Group Type ACTIVE_COMPARATOR

milk protein isolate (MPI)

Intervention Type DIETARY_SUPPLEMENT

Interventions

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soy protein isolate (SPI)

Intervention Type DIETARY_SUPPLEMENT

milk protein isolate (MPI)

Intervention Type DIETARY_SUPPLEMENT

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

Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No