Cardiovascular Disease
Conditions
Keywords
soy, hypertension, HDL-C, cholesterol efflux, cardiovascular disease
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.
Interventions
DIETARY_SUPPLEMENTSoy Protein Powder (25g/d)
Participants will consume 25g soy protein powder daily for a 6 week treatment period.
DIETARY_SUPPLEMENTPlacebo
Participants will consume a placebo control powder containing 0g soy protein powder daily for a 6 week treatment period.
DIETARY_SUPPLEMENTSoy Protein Powder (50g/d)
Participants will consume 50g soy protein powder daily for a 6 week treatment period.
Sponsors
DuPont Nutrition and Health
Penn State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 60 Years
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 * smoker * inflammatory disease * BMI outside of 18-39kg/m2 range * taking medication * refusal to discontinue any other supplement use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HDL function (RCT) as measured by cholesterol efflux. | Baseline | Prior to start of intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HDL particle size | Baseline | Prior to start of intervention |
Other
| Measure | Time frame | Description |
|---|---|---|
| Lipids (including lipoproteins and apolipoproteins) | Baseline | Prior to start of intervention |
| Central blood pressure (including augmentation index, pulse pressure, and pulse wave velocity). | Baseline | Prior to start of intervention |
Countries
United States
Outcome results
None listed