Effect of Soy on HDL-C Function, Central Blood Pressure, and Arterial Stiffness
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Penn State University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- HDL function (RCT) as measured by cholesterol efflux.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 35 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •inflammatory disease
- •BMI outside of 18-39kg/m2 range
- •taking medication
- •refusal to discontinue any other supplement use
Arms & Interventions
Control
Control powder
Intervention: Placebo (Dietary Supplement)
Control
Control powder
Intervention: Soy Protein Powder (50g/d) (Dietary Supplement)
Soy 25g
Soy protein powder (25g/day)
Intervention: Soy Protein Powder (25g/d) (Dietary Supplement)
Soy 25g
Soy protein powder (25g/day)
Intervention: Placebo (Dietary Supplement)
Soy 25g
Soy protein powder (25g/day)
Intervention: Soy Protein Powder (50g/d) (Dietary Supplement)
Soy 50g
Soy protein powder 50 g/day
Intervention: Soy Protein Powder (25g/d) (Dietary Supplement)
Soy 50g
Soy protein powder 50 g/day
Intervention: Placebo (Dietary Supplement)
Soy 50g
Soy protein powder 50 g/day
Intervention: Soy Protein Powder (50g/d) (Dietary Supplement)
Control
Control powder
Intervention: Soy Protein Powder (25g/d) (Dietary Supplement)
Outcomes
Primary Outcomes
HDL function (RCT) as measured by cholesterol efflux.
Time Frame: Week 22
End of treatment 3
HDL function (RCT) as measured by cholesterol efflux.
Time Frame: Week 6
End of treatment 1
HDL function (RCT) as measured by cholesterol efflux.
Time Frame: Week 14
End of treatment 2
HDL function (RCT) as measured by cholesterol efflux.
Time Frame: Baseline
Prior to start of intervention
Secondary Outcomes
- HDL particle size(Week 22)
- HDL particle size(Baseline)
- HDL particle size(Week 6)
- HDL particle size(Week 14)