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

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ClinicalTrials.gov Identifier: NCT02180841
Recruitment Status : Completed
First Posted : July 3, 2014
Last Update Posted : March 29, 2016
Sponsor:
Collaborator:
DuPont Nutrition and Health
Information provided by (Responsible Party):
Penny Kris-Etherton, Penn State University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Dietary Supplement: Soy Protein Powder (25g/d) Dietary Supplement: Placebo Dietary Supplement: Soy Protein Powder (50g/d) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Official Title: Effect of Soy on HDL-C Function, Central Blood Pressure, and Arterial Stiffness
Study Start Date : March 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02180841


Locations
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United States, Pennsylvania
Penn State University
University Park, Pennsylvania, United States, 16802
Sponsors and Collaborators
Penn State University
DuPont Nutrition and Health
Investigators
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Principal Investigator: Penny M Kris-Etherton, PhD Penn State University
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Responsible Party: Penny Kris-Etherton, Distinguished Professor of Nutrition, Penn State University
ClinicalTrials.gov Identifier: NCT02180841    
Other Study ID Numbers: PKE SOY
First Posted: July 3, 2014    Key Record Dates
Last Update Posted: March 29, 2016
Last Verified: March 2016
Keywords provided by Penny Kris-Etherton, Penn State University:
soy
hypertension
HDL-C
cholesterol efflux
cardiovascular disease
Additional relevant MeSH terms:
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Cardiovascular Diseases