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

Cardiovascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02024906
• Other study ID #: STUDY00000073
• Secondary ID: UL1TR000001HD002
• Status: Withdrawn
• Phase: N/A
• First received: December 27, 2013
• Last updated: September 21, 2015
• Start date: February 2015
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Hypothyroidism
• Subclinical Hypothyroid

Intervention

Dietary Supplement:
• soy protein isolate (SPI)

• milk protein isolate (MPI)

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Jill Hamilton-Reeves, PhD RD LD	Soy Nutrition Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the cardiometabolic profile	Evaluate the role of isoflavone intake on cardiovascular disease.	Change from Baseline to Week 8	No
Secondary	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 from Basesline to 8 Weeks	Yes
Secondary	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 from Basesline to 4 Weeks	Yes
Secondary	Changes in the cardiometabolic profile	Evaluate the role of isoflavone intake on cardiovascular disease.	Change from Basesline to 4 Weeks	No