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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02024906
First Posted: December 31, 2013
Last Update Posted: September 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Soy Nutrition Institute
Information provided by (Responsible Party):
Jill Hamilton-Reeves, PhD RD LD, University of Kansas Medical Center Research Institute
  Purpose
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.

Condition Intervention
Cardiovascular Disease Subclinical Hypothyroid Dietary Supplement: soy protein isolate (SPI) Dietary Supplement: milk protein isolate (MPI)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Soy Intake on Cardiovascular Disease Biomarkers in Subclinical Hypothyroid Participants

Resource links provided by NLM:


Further study details as provided by Jill Hamilton-Reeves, PhD RD LD, University of Kansas Medical Center Research Institute:

Primary Outcome Measures:
  • Changes in the cardiometabolic profile [ Time Frame: Change from Baseline to Week 8 ]
    Evaluate the role of isoflavone intake on cardiovascular disease.


Secondary Outcome Measures:
  • 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 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.

  • Changes in the cardiometabolic profile [ Time Frame: Change from Basesline to 4 Weeks ]
    Evaluate the role of isoflavone intake on cardiovascular disease.


Enrollment: 0
Study Start Date: February 2015
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02024906


Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Jill Hamilton-Reeves, PhD RD LD
Soy Nutrition Institute
Investigators
Principal Investigator: Jill Hamilton-Reeves, PhD, RD, LD University of Kansas Medical Center
  More Information

Responsible Party: Jill Hamilton-Reeves, PhD RD LD, Assistant Professor, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT02024906     History of Changes
Other Study ID Numbers: STUDY00000073
UL1TR000001 ( U.S. NIH Grant/Contract )
HD002528 ( Other Identifier: Kansas Intellectual and Developmental Disabilities Research Center )
First Submitted: December 27, 2013
First Posted: December 31, 2013
Last Update Posted: September 23, 2015
Last Verified: September 2015

Keywords provided by Jill Hamilton-Reeves, PhD RD LD, University of Kansas Medical Center Research Institute:
isoflavone
CVD
soy intake
subclinical hypothyroid

Additional relevant MeSH terms:
Cardiovascular Diseases
Hypothyroidism
Thyroid Diseases
Endocrine System Diseases