Effect of Soy on HDL-C Function, Central Blood Pressure, and Arterial Stiffness (SOY)

August 16, 2023 updated by: Penn State University
The purpose of the proposed pilot study is to evaluate the effects of a soy protein isolate with naturally occurring isoflavones on the properties of HDL-C (total HDL-C, HDL particle size and HDL function), central blood pressure, and indices of arterial stiffness.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators propose to conduct a randomized three-period, crossover study to evaluate the effect of soy protein supplementation on HDL function. To ensure that there are no effects of treatment order on outcome measures, subjects will be randomized to a treatment sequence. Healthy males and females (n = 20; 35 to 60 years of age) with systolic blood pressure greater than 120 mm Hg and/or diastolic blood pressure greater than 80 mm Hg will be recruited for this study. Subjects will undergo 3 treatment periods in random order. These treatment periods will include: A) 25 g/d soy protein powder; B) 50 g/d soy protein powder; C) 0 g/d protein powder (control). Each treatment will be provided for 6 weeks separated by a 2-week break between treatment periods. All subjects will be encouraged to maintain body weight and physical activity levels during the study.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • University Park, Pennsylvania, United States, 16802
        • Penn State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male and Female
  • 35-60 years old,with
  • Systolic blood pressure greater than 120 mm Hg
  • Diastolic blood pressure greater than 80 mm Hg
  • BMI within 18-39 kg/m2 ,
  • non smokers with
  • no inflammatory diseases and
  • not taking medication for high cholesterol, blood pressure, or glucose control

Exclusion Criteria:

  • Under 35 years of age or over 60 years old
  • Systolic blood pressure <120 or Diastolic blood pressure <80
  • smoker
  • inflammatory disease
  • BMI outside of 18-39kg/m2 range
  • taking medication
  • refusal to discontinue any other supplement use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Soy 25g
Soy protein powder (25g/day)
Dietary supplement: Soy Protein Powder (25g/d)
Participants will consume 25g soy protein powder daily for a 6 week treatment period.
Dietary supplement: Placebo
Participants will consume a placebo control powder containing 0g soy protein powder daily for a 6 week treatment period.
Dietary supplement: Soy Protein Powder (50g/d)
Participants will consume 50g soy protein powder daily for a 6 week treatment period.
Experimental: Soy 50g
Soy protein powder 50 g/day
Dietary supplement: Soy Protein Powder (25g/d)
Participants will consume 25g soy protein powder daily for a 6 week treatment period.
Dietary supplement: Placebo
Participants will consume a placebo control powder containing 0g soy protein powder daily for a 6 week treatment period.
Dietary supplement: Soy Protein Powder (50g/d)
Participants will consume 50g soy protein powder daily for a 6 week treatment period.
Placebo Comparator: Control
Control powder
Dietary supplement: Soy Protein Powder (25g/d)
Participants will consume 25g soy protein powder daily for a 6 week treatment period.
Dietary supplement: Placebo
Participants will consume a placebo control powder containing 0g soy protein powder daily for a 6 week treatment period.
Dietary supplement: Soy Protein Powder (50g/d)
Participants will consume 50g soy protein powder daily for a 6 week treatment period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HDL function (RCT) as measured by cholesterol efflux.
Time Frame: Baseline
Prior to start of intervention
Baseline
HDL function (RCT) as measured by cholesterol efflux.
Time Frame: Week 6
End of treatment 1
Week 6
HDL function (RCT) as measured by cholesterol efflux.
Time Frame: Week 14
End of treatment 2
Week 14
HDL function (RCT) as measured by cholesterol efflux.
Time Frame: Week 22
End of treatment 3
Week 22

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HDL particle size
Time Frame: Baseline
Prior to start of intervention
Baseline
HDL particle size
Time Frame: Week 6
End of treatment 1
Week 6
HDL particle size
Time Frame: Week 14
End of treatment 2
Week 14
HDL particle size
Time Frame: Week 22
End of treatment 3
Week 22

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lipids (including lipoproteins and apolipoproteins)
Time Frame: Baseline
Prior to start of intervention
Baseline
Lipids (including lipoproteins and apolipoproteins)
Time Frame: Week 6
End of treatment 1
Week 6
Lipids (including lipoproteins and apolipoproteins)
Time Frame: Week 14
End of treatment 2
Week 14
Lipids (including lipoproteins and apolipoproteins)
Time Frame: Week 22
End of treatment 3
Week 22
Central blood pressure (including augmentation index, pulse pressure, and pulse wave velocity).
Time Frame: Baseline
Prior to start of intervention
Baseline
Central blood pressure (including augmentation index, pulse pressure, and pulse wave velocity).
Time Frame: Week 6
End of treatment 1
Week 6
Central blood pressure (including augmentation index, pulse pressure, and pulse wave velocity).
Time Frame: Week 14
End of treatment 2
Week 14
Central blood pressure (including augmentation index, pulse pressure, and pulse wave velocity).
Time Frame: Week 22
End of treatment 3
Week 22

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Penn State University

Collaborators

DuPont Nutrition and Health

Investigators

  • Principal Investigator: Penny M Kris-Etherton, PhD, Penn State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

June 23, 2014

First Submitted That Met QC Criteria

July 2, 2014

First Posted (Estimated)

July 3, 2014

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

August 16, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PKE SOY

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiovascular Disease

Clinical Trials on Soy Protein Powder (25g/d)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in China

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe