Clinical trial NCT02180841: Effect of Soy on HDL-C Function, Central Blood Pressure, and Arterial Stiffness
Official title: Effect of Soy on HDL-C Function, Central Blood Pressure, and Arterial Stiffness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Keywords: soy
hypertension
HDL-C
cholesterol efflux
cardiovascular disease
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: DuPont Nutrition and Health
First posted: 2014-07-03
Enrollment: 20
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

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.

Eligibility 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

Primary outcomes:
measure: HDL function (RCT) as measured by cholesterol efflux.
timeFrame: Baseline
measure: HDL function (RCT) as measured by cholesterol efflux.
timeFrame: Week 6
measure: HDL function (RCT) as measured by cholesterol efflux.
timeFrame: Week 14
measure: HDL function (RCT) as measured by cholesterol efflux.
timeFrame: Week 22
Secondary outcomes:
measure: HDL particle size
timeFrame: Baseline
measure: HDL particle size
timeFrame: Week 6
measure: HDL particle size
timeFrame: Week 14
measure: HDL particle size
timeFrame: Week 22
Other outcomes:
measure: Lipids (including lipoproteins and apolipoproteins)
timeFrame: Baseline
measure: Lipids (including lipoproteins and apolipoproteins)
timeFrame: Week 6
measure: Lipids (including lipoproteins and apolipoproteins)
timeFrame: Week 14
measure: Lipids (including lipoproteins and apolipoproteins)
timeFrame: Week 22
measure: Central blood pressure (including augmentation index, pulse pressure, and pulse wave velocity).
timeFrame: Baseline
measure: Central blood pressure (including augmentation index, pulse pressure, and pulse wave velocity).
timeFrame: Week 6
measure: Central blood pressure (including augmentation index, pulse pressure, and pulse wave velocity).
timeFrame: Week 14
measure: Central blood pressure (including augmentation index, pulse pressure, and pulse wave velocity).
timeFrame: Week 22
Locations:
city: University Park
country: United States
facility: Penn State University
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Penny M Kris-Etherton, PhD
role: PRINCIPAL_INVESTIGATOR
References: