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

September 21, 2015 updated by: Jill Hamilton-Reeves, PhD RD LD
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: soy protein isolate (SPI)
25 grams soy protein isolate (SPI) containing approximately 30 mg/d isoflavones
Dietary supplement: soy protein isolate (SPI)
Active Comparator: milk protein isolate (MPI)
milk protein isolate (MPI) containing 0 mg/d isoflavones
Dietary supplement: milk protein isolate (MPI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the cardiometabolic profile
Time Frame: Change from Baseline to Week 8
Evaluate the role of isoflavone intake on cardiovascular disease.
Change from Baseline to Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in thyroid function
Time Frame: 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.
Change from Basesline to 8 Weeks
Change in thyroid function
Time Frame: Change from Basesline to 4 Weeks
Safety will be monitored through measuring thyroid stimulating hormone (TSH) and free thyroxine (T4) in participants while on the study.
Change from Basesline to 4 Weeks
Changes in the cardiometabolic profile
Time Frame: Change from Basesline to 4 Weeks
Evaluate the role of isoflavone intake on cardiovascular disease.
Change from Basesline to 4 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jill Hamilton-Reeves, PhD RD LD

Collaborators

Soy Nutrition Institute

Investigators

  • Principal Investigator: Jill Hamilton-Reeves, PhD, RD, LD, University of Kansas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

December 27, 2013

First Submitted That Met QC Criteria

December 27, 2013

First Posted (Estimate)

December 31, 2013

Study Record Updates

Last Update Posted (Estimate)

September 23, 2015

Last Update Submitted That Met QC Criteria

September 21, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00000073
  • UL1TR000001 (U.S. NIH Grant/Contract)
  • HD002528 (Other Identifier: Kansas Intellectual and Developmental Disabilities Research Center)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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