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

NCT02024906 | Withdrawn

• 3 other identifiers: STUDY00000073UL1TR000001HD002528
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease; Subclinical Hypothyroid

Keywords

isoflavone; CVD; soy intake; subclinical hypothyroid

Outcome Measures

Primary Outcomes (1)

• Changes in the cardiometabolic profile

  Evaluate the role of isoflavone intake on cardiovascular disease.

  Change from Baseline to Week 8

Secondary Outcomes (3)

• Change in thyroid function

  Change from Basesline to 8 Weeks

• Change in thyroid function

  Change from Basesline to 4 Weeks

• Changes in the cardiometabolic profile

  Change from Basesline to 4 Weeks

Study Arms (2)

soy protein isolate (SPI)

EXPERIMENTAL

25 grams soy protein isolate (SPI) containing approximately 30 mg/d isoflavones

Dietary Supplement: soy protein isolate (SPI)

milk protein isolate (MPI)

ACTIVE COMPARATOR

milk protein isolate (MPI) containing 0 mg/d isoflavones

Dietary Supplement: milk protein isolate (MPI)

Interventions

soy protein isolate (SPI) DIETARY_SUPPLEMENT

soy protein isolate (SPI)

milk protein isolate (MPI) DIETARY_SUPPLEMENT

milk protein isolate (MPI)

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jill Hamilton-Reeves, PhD RD LD: lead
• Soy Nutrition Institute: collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Soybean Proteins

Intervention Hierarchy (Ancestors)

Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Plant Proteins, Dietary; Dietary Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Soy Foods; Vegetable Products; Vegetables; Food and Beverages

Study Officials

• Jill Hamilton-Reeves, PhD, RD, LD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 27, 2013
• First Posted: December 31, 2013
• Study Start: February 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 23, 2015

Record last verified: 2015-09

Locations

US (1)