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| Name | Class |
|---|---|
| DuPont Nutrition and Health | INDUSTRY |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Soy 25g | Experimental | Soy protein powder (25g/day) |
|
| Soy 50g | Experimental | Soy protein powder 50 g/day |
|
| Control | Placebo Comparator | Control powder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Soy Protein Powder (25g/d) | Dietary Supplement | Participants will consume 25g soy protein powder daily for a 6 week treatment period. |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| HDL particle size | Prior to start of intervention | Baseline |
| HDL particle size | End of treatment 1 | Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Lipids (including lipoproteins and apolipoproteins) | Prior to start of intervention | Baseline |
| Lipids (including lipoproteins and apolipoproteins) | End of treatment 1 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Penny M Kris-Etherton, PhD | Penn State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State University | University Park | Pennsylvania | 16802 | United States |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
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| Placebo | Dietary Supplement | Participants will consume a placebo control powder containing 0g soy protein powder daily for a 6 week treatment period. |
|
| Soy Protein Powder (50g/d) | Dietary Supplement | Participants will consume 50g soy protein powder daily for a 6 week treatment period. |
|
| HDL particle size | End of treatment 2 | Week 14 |
| HDL particle size | End of treatment 3 | Week 22 |
| Week 6 |
| Lipids (including lipoproteins and apolipoproteins) | End of treatment 2 | Week 14 |
| Lipids (including lipoproteins and apolipoproteins) | End of treatment 3 | Week 22 |
| Central blood pressure (including augmentation index, pulse pressure, and pulse wave velocity). | Prior to start of intervention | Baseline |
| Central blood pressure (including augmentation index, pulse pressure, and pulse wave velocity). | End of treatment 1 | Week 6 |
| Central blood pressure (including augmentation index, pulse pressure, and pulse wave velocity). | End of treatment 2 | Week 14 |
| Central blood pressure (including augmentation index, pulse pressure, and pulse wave velocity). | End of treatment 3 | Week 22 |