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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cardiovascular Disease

Intervention / Treatment
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* Dietary Supplement: Soy Protein Powder (25g/d)
* Dietary Supplement: Placebo
* Dietary Supplement: Soy Protein Powder (50g/d)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Soy 25g<br>Soy protein powder (25g/day) | Dietary Supplement: Soy Protein Powder (25g/d)<br>* Participants will consume 25g soy protein powder daily for a 6 week treatment period.<br>Dietary Supplement: Placebo<br>* Participants will consume a placebo control powder containing 0g soy protein powder daily for a 6 week treatment period.<br>Dietary Supplement: Soy Protein Powder (50g/d)<br>* Participants will consume 50g soy protein powder daily for a 6 week treatment period.<br>|
| Experimental: Soy 50g<br>Soy protein powder 50 g/day | Dietary Supplement: Soy Protein Powder (25g/d)<br>* Participants will consume 25g soy protein powder daily for a 6 week treatment period.<br>Dietary Supplement: Placebo<br>* Participants will consume a placebo control powder containing 0g soy protein powder daily for a 6 week treatment period.<br>Dietary Supplement: Soy Protein Powder (50g/d)<br>* Participants will consume 50g soy protein powder daily for a 6 week treatment period.<br>|
| Placebo Comparator: Control<br>Control powder | Dietary Supplement: Soy Protein Powder (25g/d)<br>* Participants will consume 25g soy protein powder daily for a 6 week treatment period.<br>Dietary Supplement: Placebo<br>* Participants will consume a placebo control powder containing 0g soy protein powder daily for a 6 week treatment period.<br>Dietary Supplement: Soy Protein Powder (50g/d)<br>* Participants will consume 50g soy protein powder daily for a 6 week treatment period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HDL function (RCT) as measured by cholesterol efflux. | Prior to start of intervention | Baseline | 
| HDL function (RCT) as measured by cholesterol efflux. | End of treatment 1 | Week 6 | 
| HDL function (RCT) as measured by cholesterol efflux. | End of treatment 2 | Week 14 | 
| HDL function (RCT) as measured by cholesterol efflux. | End of treatment 3 | Week 22 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HDL particle size | Prior to start of intervention | Baseline | 
| HDL particle size | End of treatment 1 | Week 6 | 
| HDL particle size | End of treatment 2 | Week 14 | 
| HDL particle size | End of treatment 3 | Week 22 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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soy, HDL-C, hypertension, cholesterol efflux, cardiovascular disease