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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2014 by University of Kansas
Sponsor:
Collaborator:
Soy Nutrition Institute
Information provided by (Responsible Party):
Jill Hamilton-Reeves, PhD RD LD, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT02024906
First received: December 27, 2013
Last updated: May 19, 2014
Last verified: May 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 University of Kansas:

Primary Outcome Measures:
  • Changes in the cardiometabolic profile [ Time Frame: Change from Baseline to Week 8 ] [ Designated as safety issue: No ]
    Evaluate the role of isoflavone intake on cardiovascular disease.


Secondary Outcome Measures:
  • Change in thyroid function [ Time Frame: Change from Basesline to 8 Weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Evaluate the role of isoflavone intake on cardiovascular disease.


Estimated Enrollment: 80
Study Start Date: August 2014
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: May 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

Ages Eligible for Study:   25 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02024906

Locations
United States, Kansas
University of Kansas Medical Center Not yet recruiting
Kansas City, Kansas, United States, 66160
Contact: Jill Hamilton-Reeves, PhD, RD, LD    913-588-7650    jhamilton-reeves@kumc.edu   
Sponsors and Collaborators
Jill Hamilton-Reeves, PhD RD LD
Soy Nutrition Institute
Investigators
Principal Investigator: Jill Hamilton-Reeves, PhD, RD, LD University of Kansas
  More Information

No publications provided

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, HD002528
Study First Received: December 27, 2013
Last Updated: May 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
isoflavone
CVD
soy intake
subclinical hypothyroid

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

ClinicalTrials.gov processed this record on July 26, 2014