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Completed

NCT Number: NCT02180841

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

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.

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Key information

Age range

35 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State University

University Park, Pennsylvania, 16802, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Soy Protein Powder (25g/d)

Dietary Supplement

Participants will consume 25g soy protein powder daily for a 6 week treatment period.

Placebo

Dietary Supplement

Participants will consume a placebo control powder containing 0g soy protein powder daily for a 6 week treatment period.

Soy Protein Powder (50g/d)

Dietary Supplement

Participants will consume 50g soy protein powder daily for a 6 week treatment period.

Primary outcomes

  1. HDL function (RCT) as measured by cholesterol efflux.

    Time frame: Baseline

    Prior to start of intervention

  2. HDL function (RCT) as measured by cholesterol efflux.

    Time frame: Week 6

    End of treatment 1

  3. HDL function (RCT) as measured by cholesterol efflux.

    Time frame: Week 14

    End of treatment 2

  4. HDL function (RCT) as measured by cholesterol efflux.

    Time frame: Week 22

    End of treatment 3

Secondary outcomes

  1. HDL particle size

    Time frame: Baseline

    Prior to start of intervention

  2. HDL particle size

    Time frame: Week 6

    End of treatment 1

  3. HDL particle size

    Time frame: Week 14

    End of treatment 2

  4. HDL particle size

    Time frame: Week 22

    End of treatment 3

Other outcomes

  1. Lipids (including lipoproteins and apolipoproteins)

    Time frame: Baseline

    Prior to start of intervention

  2. Lipids (including lipoproteins and apolipoproteins)

    Time frame: Week 6

    End of treatment 1

  3. Lipids (including lipoproteins and apolipoproteins)

    Time frame: Week 14

    End of treatment 2

  4. Lipids (including lipoproteins and apolipoproteins)

    Time frame: Week 22

    End of treatment 3

  5. Central blood pressure (including augmentation index, pulse pressure, and pulse wave velocity).

    Time frame: Baseline

    Prior to start of intervention

  6. Central blood pressure (including augmentation index, pulse pressure, and pulse wave velocity).

    Time frame: Week 6

    End of treatment 1

  7. Central blood pressure (including augmentation index, pulse pressure, and pulse wave velocity).

    Time frame: Week 14

    End of treatment 2

  8. Central blood pressure (including augmentation index, pulse pressure, and pulse wave velocity).

    Time frame: Week 22

    End of treatment 3

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Collaborators

  • DuPont Nutrition and Health

Registry information

Acronym: SOY

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 3, 2014
Registry last updated
Aug 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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