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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Penn State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
DuPont Nutrition and Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 23, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 3, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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