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

Not Applicable

Withdrawn

• Conditions: Subclinical Hypothyroid; Cardiovascular Disease
• Interventions: Dietary Supplement: milk protein isolate (MPI); Dietary Supplement: soy protein isolate (SPI)

• Registration Number: NCT02024906
• Lead Sponsor: Jill Hamilton-Reeves, PhD RD LD

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.

Study Timeline

• Study First Submitted: 2013-12-27
• Study First Submitted QC: 2013-12-27
• Study First Posted: 2013-12-31
• Study Start: 2015-02
• Status Verified: 2015-09
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Last Update Submitted: 2015-09-21
• Last Update Posted: 2015-09-23

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
milk protein isolate (MPI)	milk protein isolate (MPI)	milk protein isolate (MPI) containing 0 mg/d isoflavones
soy protein isolate (SPI)	soy protein isolate (SPI)	25 grams soy protein isolate (SPI) containing approximately 30 mg/d isoflavones

Primary Outcome Measures

Name	Time	Method
Changes in the cardiometabolic profile	Change from Baseline to Week 8	Evaluate the role of isoflavone intake on cardiovascular disease.

Secondary Outcome Measures

Name	Time	Method
Change in thyroid function	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	Change from Basesline to 4 Weeks	Evaluate the role of isoflavone intake on cardiovascular disease.

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States