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The study did not enroll any subjects. It was never started because of the Covid pandemic.
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A three-period, randomized, crossover controlled feeding trial will be conducted to examine the effect of including 2 oz./day of pecans, as a snack, in a diet representative of average American intake, compared to a diet representative of average American intake devoid of nuts, and a healthy dietary pattern including 2 oz./day of pecans on markers of peripheral vascular health, lipids and lipoproteins, blood pressure, and glycemic control.
Participants will be randomized to each diet for 4-weeks with a minimum 2-week break between the diet periods. All caloric foods and beverages will be provided. Outcome assessments will be done at baseline and the end of each diet period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Average American Diet | Active Comparator | Diet representative of average American intake in terms of diet quality measured by the Healthy Eating Index-2015. |
|
| Average American Diet + Pecans | Active Comparator | Diet that approximates average American intake in terms of diet quality measured by the Healthy Eating Index-2015, but includes 2 oz./day of pecans. |
|
| Healthy Diet + Pecans | Active Comparator | High diet quality, measured by Healthy Index-2015 score >95, and includes 2 oz./day of pecans. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pecan | Drug | Unsalted raw pecans incorporated in snack and meal recipes as part of a dietary pattern |
|
| Measure | Description | Time Frame |
|---|---|---|
| Flow mediated dilation | Measured by brachial ultrasound and expressed as percent artery dilation | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| LDL-cholesterol concentration | Assessed from fasting blood draw expressed in mg/dL | 4 weeks |
| HDL-cholesterol concentrations | Assessed from fasting blood draw expressed in mg/dL |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the composition of the gut microbiota | Abundance measured using 16 s rRNA sequencing | 4 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| Average American Diet devoid of nuts | Other | Diet mimicking usual American intake |
|
| 4 weeks |
| Triglycerides | Assessed from fasting blood draw expressed in mg/dL | 4 weeks |
| LDL lipoprotein subclasses | Assessed from fasting blood draw expressed in nmol/L | 4 weeks |
| HDL lipoprotein subclasses | Assessed from fasting blood draw expressed in umol/L | 4 weeks |
| Peripheral systolic and diastolic blood pressure | Blood pressure measured assessed using a SphymoCor Ecel (Atcor Medical) | 4 weeks |
| Central systolic and diastolic blood pressure | Blood pressure measured assessed using a SphymoCor Ecel (Atcor Medical). | 4 weeks |
| Carotid-femoral pulse wave velocity | A measure of arterial stiffness assessed using a SphymoCor Ecel (Atcor Medical). Expressed in meters/second. | 4 weeks |
| Augmentation Index | A measure of arterial stiffness assessed using a SphymoCor Ecel (Atcor Medical). Expressed as a percentage. A higher percentage value is indicative of greater arterial stiffness. | 4 weeks |
| Fasting plasma glucose concentration | Fasting blood glucose assessed by blood draw and expressed in mg/dL | 4 weeks |
| Serum insulin concentration | Fasting serum insulin levels assessed by blood draw and expressed in micro IU/mL | 4 weeks |