Cardiovascular Diseases
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGPecans
Participants will receive 2 oz of pecans daily to replace a typical snack and continue consuming their usual diet for 12 weeks.
OTHERUsual Care
Participants will receive grocery vouchers and continue consuming their usual diet for 12 weeks.
Sponsors
American Pecan Council
Penn State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* BMI 25-40 kg/m2 * ≥ 1 criterion for metabolic syndrome (i.e., waist circumference ≥ 94 cm men or ≥ 80 cm women; triglycerides ≥150 mg/dL; HDL-cholesterol ≤ 40 mg/dL men or ≤ 50 mg/dL women; systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥85 mmHg; fasting plasma glucose ≥100 mg/dL) at screening
Exclusion criteria
* Current use of tobacco-containing products or (≤6 months) cessation * Allergy/sensitivity/intolerance/dislike of study foods * Women who are pregnant, lactating, planning to become pregnant or have given birth in the past year * Individuals who have had a cardiovascular event (heart attack, revascularization, stroke), or have a history of heart failure, liver, kidney, autoimmune diseases or inflammatory conditions such as gastrointestinal disorders or rheumatoid arthritis. * Type 1 or type 2 diabetes * Unstable weight ≥10% body weight for 6 months prior to enrollment * Systolic Blood pressure \>160 mmHg for systolic pressure and/or diastolic blood pressure \>/100 mmHg for diastolic pressure at screening * Fasting blood glucose ≥126 mg/dL at screening * Triglycerides ≥350 mg/dL at screening * Taking any medications known to affect lipids, blood pressure, or blood glucose levels * Diagnosed inflammatory conditions or taking prescribed , taking any chronic anti-inflammatory medications (\>1 time per week over the past 3 months) * Use of antibiotics within the prior 8 weeks * Taking supplements (e.g., psyllium, fish oil, soy lecithin, and phytoestrogens) and botanicals known to affect study outcomes and not willing to cease for the duration of the study * Individuals consuming \>14 alcoholic drinks/week, and not willing to avoid alcohol consumption for 48 hours prior to test visit * Pre-menopausal women who do not have a regular menstrual cycle of 25-35 days * PI discretion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Flow Mediated Dilation | 12 weeks | Measured by brachial ultrasound and expressed as percentage points of change in arterial diameter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| LDL-cholesterol Concentration | 12 weeks | Assessed from fasting blood draw expressed in mg/dL |
| HDL-cholesterol Concentration | 12 weeks | Assessed from fasting blood draw expressed in mg/dL |
| Triglycerides | 12 weeks | Assessed from fasting blood draw expressed in mg/dL |
| LDL Lipoprotein Subclasses | 12 weeks | 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. |
| HDL Lipoprotein Subclasses | 12 weeks | 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. |
| Brachial Systolic and Diastolic Blood Pressure | 12 weeks | Blood pressure measured assessed using a SphygmoCor Xcel (Atcor Medical) |
| Central Systolic and Diastolic Blood Pressure | 12 weeks | Blood pressure measured assessed using a SphygmoCor Xcel (Atcor Medical) |
| Carotid-femoral Pulse Wave Velocity | 12 weeks | A measure of arterial stiffness assessed using a SphygmoCor Xcel (Atcor Medical). Expressed in meters/second. Higher values indicate greater arterial stiffness |
| Fasting Plasma Glucose Concentration | 12 weeks | Fasting blood glucose assessed by blood draw and expressed in mg/dL |
| Serum Insulin Concentration | 12 weeks | Fasting serum insulin levels assessed by blood draw and expressed in micro IU/m |
| HbA1c | 12-weeks | HbA1c assessed in whole blood collected during fasting |
| Diet Quality: Healthy Eating Index 2020 | 12-weeks | 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. |
| Total Cholesterol Concentration | 12-weeks | Assessed from fasting blood draw expressed in mg/dL |
| LDL Subclasses | 12 weeks | 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. |
| HDL Subclass-Large | 12 weeks | 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. |
| Augmentation Index@75bpm | 12 weeks | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in the Composition of the Gut Microbiota | 12 weeks | Abundance measured using 16 s rRNA sequencing |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 69 |
| 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. | 69 |
| Total | 138 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Relocated | 0 | 1 |
| Overall Study | Unrelated medical issues | 3 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 0 |
Baseline characteristics
| Characteristic | Usual Care Group | Total | Pecan Group |
|---|---|---|---|
| Age, Continuous | 46 years STANDARD_DEVIATION 14 | 46 years STANDARD_DEVIATION 13 | 46 years STANDARD_DEVIATION 12 |
| Augmentation index @ 75bpm | 21 percentage of aortic pulse pressure STANDARD_DEVIATION 13 | 22 percentage of aortic pulse pressure STANDARD_DEVIATION 12 | 22 percentage of aortic pulse pressure STANDARD_DEVIATION 11 |
| Brachial blood pressure Diastolic | 79 mmHg STANDARD_DEVIATION 10 | 79 mmHg STANDARD_DEVIATION 9 | 79 mmHg STANDARD_DEVIATION 8 |
| Brachial blood pressure Systolic | 125 mmHg STANDARD_DEVIATION 11 | 124 mmHg STANDARD_DEVIATION 13 | 124 mmHg STANDARD_DEVIATION 15 |
| Central blood pressure Diastolic | 80 mmHg STANDARD_DEVIATION 8 | 80 mmHg STANDARD_DEVIATION 9 | 79 mmHg STANDARD_DEVIATION 10 |
| Central blood pressure Systolic | 114 mmHg STANDARD_DEVIATION 14 | 114 mmHg STANDARD_DEVIATION 12 | 114 mmHg STANDARD_DEVIATION 14 |
| Diet quality: Healthy Eating Index 2020 | 55.1 scores on a scale STANDARD_DEVIATION 10.7 | 56.1 scores on a scale STANDARD_DEVIATION 12.1 | 57.2 scores on a scale STANDARD_DEVIATION 13.4 |
| Flow mediated dilation | 6.1 percent point change in arterial diamete STANDARD_DEVIATION 3.3 | 6.6 percent point change in arterial diamete STANDARD_DEVIATION 3.7 | 7.2 percent point change in arterial diamete STANDARD_DEVIATION 4 |
| HbA1C | 5.5 percentage of glycated hemoglobin STANDARD_DEVIATION 0.3 | 5.5 percentage of glycated hemoglobin STANDARD_DEVIATION 0.3 | 5.5 percentage of glycated hemoglobin STANDARD_DEVIATION 0.3 |
| HDL-C | 52 mmHg STANDARD_DEVIATION 13 | 53 mmHg STANDARD_DEVIATION 13.4 | 54 mmHg STANDARD_DEVIATION 14 |
| HDL subclasses HDL total particle count | 20.6 µmol/L STANDARD_DEVIATION 2.9 | 20.7 µmol/L STANDARD_DEVIATION 2.7 | 20.7 µmol/L STANDARD_DEVIATION 2.6 |
| HDL subclasses Large | 2.3 µmol/L STANDARD_DEVIATION 1.4 | 2.4 µmol/L STANDARD_DEVIATION 1.6 | 2.5 µmol/L STANDARD_DEVIATION 1.7 |
| HDL subclasses Medium | 4.4 µmol/L STANDARD_DEVIATION 2.4 | 4.2 µmol/L STANDARD_DEVIATION 2.1 | 4.0 µmol/L STANDARD_DEVIATION 1.8 |
| HDL subclasses Small | 14.0 µmol/L STANDARD_DEVIATION 3.4 | 14.1 µmol/L STANDARD_DEVIATION 3.1 | 14.2 µmol/L STANDARD_DEVIATION 2.8 |
| LDL-C | 116 mg/dL STANDARD_DEVIATION 28 | 117 mg/dL STANDARD_DEVIATION 31 | 118 mg/dL STANDARD_DEVIATION 34 |
| LDL subclasses Large | 329 nmol/L STANDARD_DEVIATION 194 | 351 nmol/L STANDARD_DEVIATION 225 | 373 nmol/L STANDARD_DEVIATION 251 |
| LDL subclasses Medium | 312 nmol/L STANDARD_DEVIATION 255 | 339 nmol/L STANDARD_DEVIATION 261 | 366 nmol/L STANDARD_DEVIATION 267 |
| LDL subclasses Small | 698 nmol/L STANDARD_DEVIATION 353 | 660 nmol/L STANDARD_DEVIATION 396 | 623 nmol/L STANDARD_DEVIATION 435 |
| LDL subclasses Total LDL particle count | 1339 nmol/L STANDARD_DEVIATION 339 | 1350 nmol/L STANDARD_DEVIATION 396 | 1362 nmol/L STANDARD_DEVIATION 399 |
| Plasma glucose | 98 mg/dL STANDARD_DEVIATION 8 | 98 mg/dL STANDARD_DEVIATION 7.4 | 97 mg/dL STANDARD_DEVIATION 7 |
| Pulse wave velocity | 7.2 m/s STANDARD_DEVIATION 1.2 | 7.2 m/s STANDARD_DEVIATION 1.3 | 7.1 m/s STANDARD_DEVIATION 1.3 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 69 participants | 138 participants | 69 participants |
| Serum insulin | 8.8 μIU/mL STANDARD_DEVIATION 3.5 | 9.1 μIU/mL STANDARD_DEVIATION 4.3 | 9.4 μIU/mL STANDARD_DEVIATION 5 |
| Sex: Female, Male Female | 36 Participants | 81 Participants | 45 Participants |
| Sex: Female, Male Male | 33 Participants | 57 Participants | 24 Participants |
| Total Cholesterol concentration | 190 mg/dL STANDARD_DEVIATION 32 | 192 mg/dL STANDARD_DEVIATION 36 | 194 mg/dL STANDARD_DEVIATION 39 |
| Triglycerides | 116 mmHg STANDARD_DEVIATION 47 | 113 mmHg STANDARD_DEVIATION 58 | 109 mmHg STANDARD_DEVIATION 67 |
| Waist circumference | 98.8 cm STANDARD_DEVIATION 10.8 | 98.0 cm STANDARD_DEVIATION 9.9 | 97.2 cm STANDARD_DEVIATION 8.8 |
| Weight | 85.2 kg STANDARD_DEVIATION 14.3 | 84.8 kg STANDARD_DEVIATION 13.4 | 84.3 kg STANDARD_DEVIATION 12.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 69 | 0 / 69 |
| other Total, other adverse events | 2 / 69 | 0 / 69 |
| serious Total, serious adverse events | 0 / 69 | 0 / 69 |
Outcome results
Primary
Flow Mediated Dilation
Measured by brachial ultrasound and expressed as percentage points of change in arterial diameter
Time frame: 12 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pecan Group | Flow Mediated Dilation | 7.07 percent point change in arterial diamete | Standard Error 0.35 |
| Usual Care Group | Flow Mediated Dilation | 7.25 percent point change in arterial diamete | Standard Error 0.33 |
Comparison: To detect a 1.2 percentage point (standard deviation 2.4; effect size 0.5) between-group difference in the change in FMD with 80% power (α=0.05), it was estimated that a sample size of 128 participants was needed (64 per group)95% CI: [-1.17, 1.33]Regression, Linear
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.
Time frame: 12 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pecan Group | Augmentation Index@75bpm | 21 percentage of aortic pulse pressure | Standard Error 0.65 |
| Usual Care Group | Augmentation Index@75bpm | 22 percentage of aortic pulse pressure | Standard Error 0.65 |
95% CI: [-4.25, 0.95]Regression, Linear
Secondary
Brachial Systolic and Diastolic Blood Pressure
Blood pressure measured assessed using a SphygmoCor Xcel (Atcor Medical)
Time frame: 12 weeks
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pecan Group | Brachial Systolic and Diastolic Blood Pressure | Systolic | 125 mmHg | Standard Error 0.81 |
| Pecan Group | Brachial Systolic and Diastolic Blood Pressure | Diastolic | 79 mmHg | Standard Error 0.5 |
| Usual Care Group | Brachial Systolic and Diastolic Blood Pressure | Systolic | 125 mmHg | Standard Error 0.77 |
| Usual Care Group | Brachial Systolic and Diastolic Blood Pressure | Diastolic | 79 mmHg | Standard Error 0.47 |
Comparison: Results from brachial systolic blood pressure are reported below95% CI: [-3.09, 3.13]Regression, Linear
Comparison: Results for Brachial Diastolic Blood pressure95% CI: [-1.67, 2.07]Regression, Linear
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
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pecan Group | Carotid-femoral Pulse Wave Velocity | 7.1 m/s | Standard Deviation 1.3 |
| Usual Care Group | Carotid-femoral Pulse Wave Velocity | 7.3 m/s | Standard Deviation 1.3 |
95% CI: [-0.26, 0.24]Regression, Linear
Secondary
Central Systolic and Diastolic Blood Pressure
Blood pressure measured assessed using a SphygmoCor Xcel (Atcor Medical)
Time frame: 12 weeks
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pecan Group | Central Systolic and Diastolic Blood Pressure | Systolic | 114 mmHg | Standard Error 0.7 |
| Pecan Group | Central Systolic and Diastolic Blood Pressure | Diastolic | 80 mmHg | Standard Error 0.5 |
| Usual Care Group | Central Systolic and Diastolic Blood Pressure | Systolic | 115 mmHg | Standard Error 0.69 |
| Usual Care Group | Central Systolic and Diastolic Blood Pressure | Diastolic | 80 mmHg | Standard Error 0.48 |
Comparison: Results for central systolic blood pressure95% CI: [-3.24, 2.28]Regression, Linear
Comparison: Results for central diastolic blood pressure95% CI: [-1.69, 2.1]Regression, Linear
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.
Time frame: 12-weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pecan Group | Diet Quality: Healthy Eating Index 2020 | 60.8 scores on a scale | Standard Error 1.1 |
| Usual Care Group | Diet Quality: Healthy Eating Index 2020 | 51.5 scores on a scale | Standard Error 1 |
95% CI: [5, 13.7]Mixed Models Analysis
Secondary
Fasting Plasma Glucose Concentration
Fasting blood glucose assessed by blood draw and expressed in mg/dL
Time frame: 12 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pecan Group | Fasting Plasma Glucose Concentration | 97.7 mg/dL | Standard Error 0.48 |
| Usual Care Group | Fasting Plasma Glucose Concentration | 96.7 mg/dL | Standard Error 0.45 |
95% CI: [-0.6, 3]Regression, Linear
Secondary
HbA1c
HbA1c assessed in whole blood collected during fasting
Time frame: 12-weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pecan Group | HbA1c | 5.53 percentage of glycated hemoglobin | Standard Error 0.01 |
| Usual Care Group | HbA1c | 5.49 percentage of glycated hemoglobin | Standard Error 0.01 |
95% CI: [0, 0.1]Regression, Linear
Secondary
HDL-cholesterol Concentration
Assessed from fasting blood draw expressed in mg/dL
Time frame: 12 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pecan Group | HDL-cholesterol Concentration | 54 mg/dL | Standard Error 0.47 |
| Usual Care Group | HDL-cholesterol Concentration | 53 mg/dL | Standard Error 0.44 |
95% CI: [-0.8, 2.9]Regression, Linear
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.
Time frame: 12 weeks
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pecan Group | HDL Lipoprotein Subclasses | Medium | 4.1 μmol/L | Standard Error 0.1 |
| Pecan Group | HDL Lipoprotein Subclasses | Small | 14.1 μmol/L | Standard Error 0.2 |
| Pecan Group | HDL Lipoprotein Subclasses | Total | 21.0 μmol/L | Standard Error 0.17 |
| Usual Care Group | HDL Lipoprotein Subclasses | Medium | 4.4 μmol/L | Standard Error 0.1 |
| Usual Care Group | HDL Lipoprotein Subclasses | Small | 14.3 μmol/L | Standard Error 0.2 |
| Usual Care Group | HDL Lipoprotein Subclasses | Total | 21.0 μmol/L | Standard Error 0.16 |
Comparison: Results for total HDL particle count95% CI: [-0.56, 0.75]Regression, Linear
Comparison: Results for Small HDL particles95% CI: [-0.75, 0.8]
Comparison: Results for Medium HDL95% CI: [-0.85, 0.19]Regression, Linear
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.
Time frame: 12 weeks
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Pecan Group | HDL Subclass-Large | 2.2 μmol/L |
| Usual Care Group | HDL Subclass-Large | 2.0 μmol/L |
95% CI: [0.07, 0.63]Regression, Linear
Secondary
LDL-cholesterol Concentration
Assessed from fasting blood draw expressed in mg/dL
Time frame: 12 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pecan Group | LDL-cholesterol Concentration | 110 mg/dL | Standard Error 1.35 |
| Usual Care Group | LDL-cholesterol Concentration | 117 mg/dL | Standard Error 1.26 |
95% CI: [-12.3, -2.1]Regression, Linear
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.
Time frame: 12 weeks
| Arm | Measure | Group | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Pecan Group | LDL Lipoprotein Subclasses | Large | 281 nmol/L |
| Pecan Group | LDL Lipoprotein Subclasses | Total | 1248 nmol/L |
| Usual Care Group | LDL Lipoprotein Subclasses | Large | 252 nmol/L |
| Usual Care Group | LDL Lipoprotein Subclasses | Total | 1304 nmol/L |
Comparison: Total LDL particle mean difference95% CI: [-144, -6.93]Regression, Linear
Comparison: For Large LDL particle subclass95% CI: [-69.3, 13.4]Regression, Linear
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.
Time frame: 12 weeks
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pecan Group | LDL Subclasses | Medium | 297 nmol/L | Standard Error 20.2 |
| Pecan Group | LDL Subclasses | Small | 684 nmol/L | Standard Error 24.5 |
| Usual Care Group | LDL Subclasses | Small | 677 nmol/L | Standard Error 23.2 |
| Usual Care Group | LDL Subclasses | Medium | 337 nmol/L | Standard Error 19.1 |
Comparison: Results for medium subclass; 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.95% CI: [-98.6, 47.5]Regression, Linear
Comparison: 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.95% CI: [-91.8, 95.5]Regression, Linear
Secondary
Serum Insulin Concentration
Fasting serum insulin levels assessed by blood draw and expressed in micro IU/m
Time frame: 12 weeks
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Pecan Group | Serum Insulin Concentration | 8.42 μIU/mL |
| Usual Care Group | Serum Insulin Concentration | 8.33 μIU/mL |
95% CI: [-2.3, 1.6]Regression, Linear
Secondary
Total Cholesterol Concentration
Assessed from fasting blood draw expressed in mg/dL
Time frame: 12-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pecan Group | Total Cholesterol Concentration | 185 mg/dL | Standard Error 1.69 |
| Usual Care Group | Total Cholesterol Concentration | 193 mg/dL | Standard Error 1.59 |
95% CI: [-14.5, -1.7]Regression, Linear
Secondary
Triglycerides
Assessed from fasting blood draw expressed in mg/dL
Time frame: 12 weeks
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Pecan Group | Triglycerides | 97.7 mg/dL |
| Usual Care Group | Triglycerides | 108 mg/dL |
95% CI: [-30, -2.9]Regression, Linear
Other Pre-specified
Change in the Composition of the Gut Microbiota
Abundance measured using 16 s rRNA sequencing
Time frame: 12 weeks