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

Primary Purpose

Cardiovascular Disease, Subclinical Hypothyroid

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

soy protein isolate (SPI)

milk protein isolate (MPI)

About this trial

This is an interventional treatment trial for Cardiovascular Disease focused on measuring isoflavone, CVD, soy intake, subclinical hypothyroid

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University of Kansas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

soy protein isolate (SPI)

milk protein isolate (MPI)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Changes in the cardiometabolic profile

Evaluate the role of isoflavone intake on cardiovascular disease.

Secondary Outcome Measures

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 in thyroid function

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

Evaluate the role of isoflavone intake on cardiovascular disease.

Full Information

NCT ID

NCT02024906

First Posted

December 27, 2013

Last Updated

September 21, 2015

Sponsor

Jill Hamilton-Reeves, PhD RD LD

Collaborators

Soy Nutrition Institute

1. Study Identification

Unique Protocol Identification Number

NCT02024906

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Withdrawn

Study Start Date

February 2015 (undefined)

Primary Completion Date

September 2015 (Actual)

Study Completion Date

September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Jill Hamilton-Reeves, PhD RD LD

Collaborators

Soy Nutrition Institute

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiovascular Disease, Subclinical Hypothyroid

Keywords

isoflavone, CVD, soy intake, subclinical hypothyroid

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

soy protein isolate (SPI)

Arm Type

Experimental

Arm Description

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

Arm Title

milk protein isolate (MPI)

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

soy protein isolate (SPI)

Intervention Type

Dietary Supplement

Intervention Name(s)

milk protein isolate (MPI)

Primary Outcome Measure Information:

Title

Changes in the cardiometabolic profile

Description

Evaluate the role of isoflavone intake on cardiovascular disease.

Time Frame

Change from Baseline to Week 8

Secondary Outcome Measure Information:

Title

Change in thyroid function

Description

Safety will be monitored through measuring thyroid stimulating hormone (TSH) and free thyroxine (T4) in participants while on the study.

Time Frame

Change from Basesline to 8 Weeks

Title

Change in thyroid function

Description

Safety will be monitored through measuring thyroid stimulating hormone (TSH) and free thyroxine (T4) in participants while on the study.

Time Frame

Change from Basesline to 4 Weeks

Title

Changes in the cardiometabolic profile

Description

Evaluate the role of isoflavone intake on cardiovascular disease.

Time Frame

Change from Basesline to 4 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jill Hamilton-Reeves, PhD, RD, LD

Organizational Affiliation

University of Kansas Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Kansas Medical Center

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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