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| Name | Class |
|---|---|
| American Pecan Council | OTHER |
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A randomized, 2-arm, parallel trial will be conducted to examine the effect of pecans on markers of peripheral vascular health, lipids and lipoproteins, blood pressure, and glycemic control.
A randomized, 2-arm, parallel trial will be conducted to examine the effect of including 2 oz./day of pecans, as a snack, compared to a diet typically consumed by participants intake (devoid of nuts) on markers of peripheral vascular health, lipids and lipoproteins, blood pressure, and glycemic control. Participants will be randomized to pecans or control for 12-weeks. Outcome assessments will be measured at baseline and 12-weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pecan Group | Active Comparator | Participants will consume their usual diet, but replace one snack with unsalted raw pecans incorporated as a snack |
|
| Usual Care Group | Active Comparator | Participants will consume their usual diet devoid of nuts |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pecans | Drug | Participants will receive 2 oz of pecans daily to replace a typical snack and continue consuming their usual diet for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Flow Mediated Dilation | Measured by brachial ultrasound and expressed as percentage points of change in arterial diameter | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| LDL-cholesterol Concentration | Assessed from fasting blood draw expressed in mg/dL | 12 weeks |
| HDL-cholesterol Concentration | 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 | 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristina Petersen, PhD | Penn State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State University | University Park | Pennsylvania | 16802 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40386548 | Derived | Hart TL, Kris-Etherton PM, Petersen KS. Nutrient Displacement Associated with Replacing Intake of Usual Snacks with Pecans: An Exploratory Analysis of a Randomized Controlled Trial. Curr Dev Nutr. 2025 Apr 9;9(5):107438. doi: 10.1016/j.cdnut.2025.107438. eCollection 2025 May. | |
| 40113170 | Derived | Hart TL, Kris-Etherton PM, Petersen KS. Pecan Intake Improves Lipoprotein Particle Concentrations Compared with Usual Intake in Adults at Increased Risk of Cardiometabolic Diseases: A Randomized Controlled Trial. J Nutr. 2025 May;155(5):1459-1465. doi: 10.1016/j.tjnut.2025.03.014. Epub 2025 Mar 18. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pecan Group | Participants will consume their usual diet, but replace one snack with unsalted raw pecans incorporated as a snack Pecans: Participants will receive 2 oz of pecans daily to replace a typical snack and continue consuming their usual diet for 12 weeks. |
| FG001 | Usual Care Group | Participants will consume their usual diet devoid of nuts Usual Care: Participants will receive grocery vouchers and continue consuming their usual diet for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pecan Group | Participants will consume their usual diet, but replace one snack with unsalted raw pecans incorporated as a snack Pecans: Participants will receive 2 oz of pecans daily to replace a typical snack and continue consuming their usual diet for 12 weeks. |
| BG001 | Usual Care Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Flow Mediated Dilation | Measured by brachial ultrasound and expressed as percentage points of change in arterial diameter | Posted | Least Squares Mean | Standard Error | percent point change in arterial diamete | 12 weeks |
|
3 months
No deaths occurred no serious adverse events occurred.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pecan Group | Participants will consume their usual diet, but replace one snack with unsalted raw pecans incorporated as a snack Pecans: Participants will receive 2 oz of pecans daily to replace a typical snack and continue consuming their usual diet for 12 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendectomy | Gastrointestinal disorders | Non-systematic Assessment | Participant had appendectomy during the trial and was excluded from the remainder of the study |
Increased risk of type 1 statistical error. Dietary data was self-reported.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| DCH Lab | Penn State University | 8148638056 | dchlab@psu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 19, 2023 | Feb 4, 2025 | Prot_004.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 19, 2023 | Feb 4, 2025 | SAP_005.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 22, 2022 | Feb 4, 2025 | ICF_006.pdf |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| Usual Care | Other | Participants will receive grocery vouchers and continue consuming their usual diet for 12 weeks. |
|
| 12 weeks |
| Triglycerides | Assessed from fasting blood draw expressed in mg/dL | 12 weeks |
| LDL Lipoprotein Subclasses | Assessed from fasting blood draw expressed in nmol/L. Data were log transformed and back transformed to improve residual distribution; Measure Description: LDL particle size classifications are as follows: 22-25.5 nm is small, 25.6-26.5 nm medium, and 26.6-28.5 nm large. Typically, smaller LDL is associated with increased cardiovascular risk compared to larger. | 12 weeks |
| HDL Lipoprotein Subclasses | Assessed from fasting blood draw expressed in µmol/L; Measure Description: Size classifications of HDL subclasses are as follows: large (size 9.4-14.0 nm), medium (8.3-9.3 nm), and small (7.3-8.2 nm). Higher levels of large HDL may be inversely related to cardiovascular risk. | 12 weeks |
| Brachial Systolic and Diastolic Blood Pressure | Blood pressure measured assessed using a SphygmoCor Xcel (Atcor Medical) | 12 weeks |
| Central Systolic and Diastolic Blood Pressure | Blood pressure measured assessed using a SphygmoCor Xcel (Atcor Medical) | 12 weeks |
| Carotid-femoral Pulse Wave Velocity | A measure of arterial stiffness assessed using a SphygmoCor Xcel (Atcor Medical). Expressed in meters/second. Higher values indicate greater arterial stiffness | 12 weeks |
| Augmentation Index@75bpm | A measure of arterial stiffness assessed using a SphygmoCor Xcel (Atcor Medical). Expressed as a percentage. A higher percentage value is indicative of greater arterial stiffness. Measure Description: Augmentation index is a measure of arterial stiffening that correlates with CVD risk. Higher augmentation index, used as a surrogate for wave reflection, is indicative of additional load on the left ventricle. Augmentation index is calculated as augmentation pressure/pulse pressure*100 to provide a percent. We utilized the Sphymocor Xcel for this measure. We used standardized augmentation index at 75 bpm for heart rate. | 12 weeks |
| Fasting Plasma Glucose Concentration | Fasting blood glucose assessed by blood draw and expressed in mg/dL | 12 weeks |
| Serum Insulin Concentration | Fasting serum insulin levels assessed by blood draw and expressed in micro IU/m | 12 weeks |
| HbA1c | HbA1c assessed in whole blood collected during fasting | 12-weeks |
| Diet Quality: Healthy Eating Index 2020 | Diet quality measured by 24-hour recalls will be assessed using Health Eating Index 2020 (HEI-2020) scores range from 0-100 with 100 indicating perfect adherence to dietary guidelines and 0 indicating no adherence. The HEI-2020 includes 13 components; 9 components are adequacy (i.e., consuming more results in a higher score), and 4 are moderation (i.e., consuming less results in a higher score). The HEI-2020 was calculated with the Statistical Analysis System (SAS) code from the National Cancer Institute. | 12-weeks |
| Total Cholesterol Concentration | Assessed from fasting blood draw expressed in mg/dL | 12-weeks |
| LDL Subclasses | LDL subclasses with normal distribution; Measure Description: LDL particle size classifications are as follows: 22-25.5 nm is small, 25.6-26.5 nm medium, and 26.6-28.5 nm large. Typically, smaller LDL is associated with increased cardiovascular risk compared to larger. | 12 weeks |
| HDL Subclass-Large | Measure was log transformed and back transformed to improve distribution; results for large HDL subclass are presented; Measure Description: Size classifications of HDL subclasses are as follows: large (size 9.4-14.0 nm), medium (8.3-9.3 nm), and small (7.3-8.2 nm). Higher levels of large HDL may be inversely related to cardiovascular risk. | 12 weeks |
| 39880306 | Derived | Hart TL, Kris-Etherton PM, Petersen KS. Consuming pecans as a snack improves lipids/lipoproteins and diet quality compared with usual diet in adults at increased risk of cardiometabolic diseases: a randomized controlled trial. Am J Clin Nutr. 2025 Apr;121(4):769-778. doi: 10.1016/j.ajcnut.2025.01.024. Epub 2025 Jan 27. |
| Relocated |
|
Participants will consume their usual diet devoid of nuts Usual Care: Participants will receive grocery vouchers and continue consuming their usual diet for 12 weeks. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| Waist circumference | Mean | Standard Deviation | cm |
|
| Pulse wave velocity | Mean | Standard Deviation | m/s |
|
| Flow mediated dilation | FMD unit is percentage point change in brachial artery Flow Mediated Dilation (FMD). Higher values are associated with lower risk of cardiovascular events https://doi.org/10.1093/eurheartj/ehz350. | Mean | Standard Deviation | percent point change in arterial diamete |
|
| LDL-C | Mean | Standard Deviation | mg/dL |
|
| HDL-C | Mean | Standard Deviation | mmHg |
|
| Triglycerides | Mean | Standard Deviation | mmHg |
|
| LDL subclasses | LDL particle size classifications are as follows: 22-25.5 nm is small, 25.6-26.5 nm medium, and 26.6-28.5 nm large. Typically, smaller LDL is associated with increased cardiovascular risk compared to larger. | Mean | Standard Deviation | nmol/L |
|
| HDL subclasses | Size classifications of HDL subclasses are as follows: large (size 9.4-14.0 nm), medium (8.3-9.3 nm), and small (7.3-8.2 nm). Higher levels of large HDL may be inversely related to cardiovascular risk. | Mean | Standard Deviation | µmol/L |
|
| Brachial blood pressure | Mean | Standard Deviation | mmHg |
|
| Central blood pressure | Mean | Standard Deviation | mmHg |
|
| Augmentation index @ 75bpm | Augmentation index is a measure of arterial stiffening that correlates with CVD risk. Higher augmentation index, used as a surrogate for wave reflection, is indicative of additional load on the left ventricle. Augmentation index is calculated as augmentation pressure/pulse pressure*100 to provide a percent. We utilized the Sphymocor Xcel for this measure. We used standardized augmentation index at 75 bpm for heart rate. | Mean | Standard Deviation | percentage of aortic pulse pressure |
|
| Plasma glucose | Mean | Standard Deviation | mg/dL |
|
| Serum insulin | Mean | Standard Deviation | μIU/mL |
|
| HbA1C | Mean | Standard Deviation | percentage of glycated hemoglobin |
|
| Diet quality: Healthy Eating Index 2020 | The Healthy Eating Index-2020 (HEI-2020) includes 13 components; 9 components are adequacy (i.e., consuming more results in a higher score), and 4 are moderation (i.e., consuming less results in a higher score) and measures adherence to the Dietary Guidelines for Americans 2020-2025. The simple HEI scoring algorithm per person was used with all reliable recalls from each timepoint to determine the HEI-2020 score for the timepoint. Scores range from 0 indicating no adherence to the dietary guidelines to 100 showing perfect adherence. | Mean | Standard Deviation | scores on a scale |
|
| Total Cholesterol concentration | Mean | Standard Deviation | mg/dL |
|
|
|
|
| Secondary | LDL-cholesterol Concentration | Assessed from fasting blood draw expressed in mg/dL | Posted | Least Squares Mean | Standard Error | mg/dL | 12 weeks |
|
|
|
|
| Secondary | HDL-cholesterol Concentration | Assessed from fasting blood draw expressed in mg/dL | Posted | Least Squares Mean | Standard Error | mg/dL | 12 weeks |
|
|
|
|
| Secondary | Triglycerides | Assessed from fasting blood draw expressed in mg/dL | Posted | Geometric Least Squares Mean | 95% Confidence Interval | mg/dL | 12 weeks |
|
|
|
|
| Secondary | LDL Lipoprotein Subclasses | Assessed from fasting blood draw expressed in nmol/L. Data were log transformed and back transformed to improve residual distribution; Measure Description: LDL particle size classifications are as follows: 22-25.5 nm is small, 25.6-26.5 nm medium, and 26.6-28.5 nm large. Typically, smaller LDL is associated with increased cardiovascular risk compared to larger. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | nmol/L | 12 weeks |
|
|
|
|
| Secondary | HDL Lipoprotein Subclasses | Assessed from fasting blood draw expressed in µmol/L; Measure Description: Size classifications of HDL subclasses are as follows: large (size 9.4-14.0 nm), medium (8.3-9.3 nm), and small (7.3-8.2 nm). Higher levels of large HDL may be inversely related to cardiovascular risk. | Posted | Least Squares Mean | Standard Error | μmol/L | 12 weeks |
|
|
|
|
| Secondary | Brachial Systolic and Diastolic Blood Pressure | Blood pressure measured assessed using a SphygmoCor Xcel (Atcor Medical) | Posted | Least Squares Mean | Standard Error | mmHg | 12 weeks |
|
|
|
|
| Secondary | Central Systolic and Diastolic Blood Pressure | Blood pressure measured assessed using a SphygmoCor Xcel (Atcor Medical) | Posted | Least Squares Mean | Standard Error | mmHg | 12 weeks |
|
|
|
|
| Secondary | Carotid-femoral Pulse Wave Velocity | A measure of arterial stiffness assessed using a SphygmoCor Xcel (Atcor Medical). Expressed in meters/second. Higher values indicate greater arterial stiffness | Posted | Mean | Standard Deviation | m/s | 12 weeks |
|
|
|
|
| Secondary | Augmentation Index@75bpm | A measure of arterial stiffness assessed using a SphygmoCor Xcel (Atcor Medical). Expressed as a percentage. A higher percentage value is indicative of greater arterial stiffness. Measure Description: Augmentation index is a measure of arterial stiffening that correlates with CVD risk. Higher augmentation index, used as a surrogate for wave reflection, is indicative of additional load on the left ventricle. Augmentation index is calculated as augmentation pressure/pulse pressure*100 to provide a percent. We utilized the Sphymocor Xcel for this measure. We used standardized augmentation index at 75 bpm for heart rate. | Posted | Least Squares Mean | Standard Error | percentage of aortic pulse pressure | 12 weeks |
|
|
|
|
| Secondary | Fasting Plasma Glucose Concentration | Fasting blood glucose assessed by blood draw and expressed in mg/dL | Posted | Least Squares Mean | Standard Error | mg/dL | 12 weeks |
|
|
|
|
| Secondary | Serum Insulin Concentration | Fasting serum insulin levels assessed by blood draw and expressed in micro IU/m | Posted | Geometric Least Squares Mean | 95% Confidence Interval | μIU/mL | 12 weeks |
|
|
|
|
| Secondary | HbA1c | HbA1c assessed in whole blood collected during fasting | Posted | Least Squares Mean | Standard Error | percentage of glycated hemoglobin | 12-weeks |
|
|
|
|
| Secondary | Diet Quality: Healthy Eating Index 2020 | Diet quality measured by 24-hour recalls will be assessed using Health Eating Index 2020 (HEI-2020) scores range from 0-100 with 100 indicating perfect adherence to dietary guidelines and 0 indicating no adherence. The HEI-2020 includes 13 components; 9 components are adequacy (i.e., consuming more results in a higher score), and 4 are moderation (i.e., consuming less results in a higher score). The HEI-2020 was calculated with the Statistical Analysis System (SAS) code from the National Cancer Institute. | Posted | Least Squares Mean | Standard Error | scores on a scale | 12-weeks |
|
|
|
|
| Secondary | Total Cholesterol Concentration | Assessed from fasting blood draw expressed in mg/dL | Posted | Mean | Standard Error | mg/dL | 12-weeks |
|
|
|
|
| Secondary | LDL Subclasses | LDL subclasses with normal distribution; Measure Description: LDL particle size classifications are as follows: 22-25.5 nm is small, 25.6-26.5 nm medium, and 26.6-28.5 nm large. Typically, smaller LDL is associated with increased cardiovascular risk compared to larger. | Posted | Least Squares Mean | Standard Error | nmol/L | 12 weeks |
|
|
|
|
| Secondary | HDL Subclass-Large | Measure was log transformed and back transformed to improve distribution; results for large HDL subclass are presented; Measure Description: Size classifications of HDL subclasses are as follows: large (size 9.4-14.0 nm), medium (8.3-9.3 nm), and small (7.3-8.2 nm). Higher levels of large HDL may be inversely related to cardiovascular risk. | Posted | Geometric Mean | 95% Confidence Interval | μmol/L | 12 weeks |
|
|
|
|
| Other Pre-specified | Change in the Composition of the Gut Microbiota | Abundance measured using 16 s rRNA sequencing | Not Posted | 12 weeks | Participants |
| 0 |
| 69 |
| 0 |
| 69 |
| 2 |
| 69 |
| EG001 | Usual Care Group | Participants will consume their usual diet devoid of nuts Usual Care: Participants will receive grocery vouchers and continue consuming their usual diet for 12 weeks. | 0 | 69 | 0 | 69 | 0 | 69 |
|
| Gastric resection | Gastrointestinal disorders | Non-systematic Assessment | Participant underwent gastric resection during trial |
|
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For Large LDL particle subclass
| Regression, Linear |
adjustment for the baseline value, age (years), sex (male or female) and body mass index (BMI) (kg/m2) |
| Mean Difference (Net) |
| -27.9 |
| 2-Sided |
| 95 |
| -69.3 |
| 13.4 |
| Superiority |
| Total |
|
Results for Small HDL particles
Adjusted for baseline value, age, sex, and BMI |
| Mean Difference (Net) |
| 0.03 |
| 2-Sided |
| 95 |
| -0.75 |
| 0.80 |
| Superiority |
| Results for Medium HDL | Regression, Linear | Adjusted for baseline value, age, sex, and BMI | Mean Difference (Net) | -0.33 | 2-Sided | 95 | -0.85 | 0.19 | Superiority |
Results for Brachial Diastolic Blood pressure |
| Regression, Linear |
Adjusted for baseline value, age, sex, BMI |
| Mean Difference (Net) |
| 0.20 |
| 2-Sided |
| 95 |
| -1.67 |
| 2.07 |
| Superiority |
| Regression, Linear |
Adjusted for baseline value, age, sex, BMI |
| Median Difference (Net) |
| 0.21 |
| 2-Sided |
| 95 |
| -1.69 |
| 2.10 |
| Superiority |
| Results for Small LDL particles; Measure Description: LDL particle size classifications are as follows: 22-25.5 nm is small, 25.6-26.5 nm medium, and 26.6-28.5 nm large. Typically, smaller LDL is associated with increased cardiovascular risk compared to larger. | Regression, Linear | adjustment for the baseline value, age (years), sex (male or female) and body mass index (BMI) (kg/m2) | Mean Difference (Net) | 1.86 | 2-Sided | 95 | -91.8 | 95.5 | Superiority |