ClinicalTrials.gg
Sign In
CompletedNCT05071807Updated Feb 25, 2025Results posted

Cardiometabolic Effects of Pecans as a Snack

A Phase 2 interventional study of Pecans and Usual Care in Cardiovascular Diseases, sponsored by Penn State University. Completed at 1 site in United States. Open to participants aged 25 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-25.

Sponsored by Penn State University · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
138
Allocation
Randomized
Ages
25 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cardiovascular Diseases
03

In context

Cardiovascular Diseases

5,025 studies on the registry are indexed under Cardiovascular Diseases; 930 are open to participants now.

This study's enrollment of 138 is above the median of 100 across 2,801 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Penn State University is the lead sponsor of 269 studies on the registry; 52 are open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 11 (73%) have results posted.

Browse Penn State University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
138 participants (actual)

Study arms

  • Active comparator
    Pecan Group

    Participants will consume their usual diet, but replace one snack with unsalted raw pecans incorporated as a snack

    Drug: Pecans

  • Active comparator
    Usual Care Group

    Participants will consume their usual diet devoid of nuts

    Other: Usual Care

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.

06

What researchers measure

Primary outcomes

  1. Flow Mediated Dilation

    Measured by brachial ultrasound and expressed as percentage points of change in arterial diameter

    Time frame: 12 weeks

Secondary outcomes

  1. LDL-cholesterol Concentration

    Assessed from fasting blood draw expressed in mg/dL

    Time frame: 12 weeks

  2. HDL-cholesterol Concentration

    Assessed from fasting blood draw expressed in mg/dL

    Time frame: 12 weeks

  3. Triglycerides

    Assessed from fasting blood draw expressed in mg/dL

    Time frame: 12 weeks

  4. 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

  5. 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

  6. Brachial Systolic and Diastolic Blood Pressure

    Blood pressure measured assessed using a SphygmoCor Xcel (Atcor Medical)

    Time frame: 12 weeks

  7. Central Systolic and Diastolic Blood Pressure

    Blood pressure measured assessed using a SphygmoCor Xcel (Atcor Medical)

    Time frame: 12 weeks

  8. 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

  9. 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

  10. Fasting Plasma Glucose Concentration

    Fasting blood glucose assessed by blood draw and expressed in mg/dL

    Time frame: 12 weeks

  11. Serum Insulin Concentration

    Fasting serum insulin levels assessed by blood draw and expressed in micro IU/m

    Time frame: 12 weeks

  12. HbA1c

    HbA1c assessed in whole blood collected during fasting

    Time frame: 12-weeks

  13. 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

  14. Total Cholesterol Concentration

    Assessed from fasting blood draw expressed in mg/dL

    Time frame: 12-weeks

  15. 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

  16. 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

Other outcomes

  1. Change in the Composition of the Gut Microbiota

    Abundance measured using 16 s rRNA sequencing

    Time frame: 12 weeks

07

Results

Posted Feb 25, 2025
Limitations and caveats
Increased risk of type 1 statistical error. Dietary data was self-reported.

Participant flow

Participant flow — Overall Study
MilestonePecan GroupUsual Care Group
Started6969
Completed6268
Not completed71
Withdrew: Withdrawal by subject40
Withdrew: Unrelated medical issues30
Withdrew: Relocated01

Outcome measures

PrimaryFlow Mediated Dilation

Measured by brachial ultrasound and expressed as percentage points of change in arterial diameter

Time frame:
12 weeks
Reported as:
Least squares mean · percent point change in arterial diamete
Flow Mediated Dilation
percent point change in arterial diametePecan GroupUsual Care Group
Flow Mediated Dilation7.07 ± 0.357.25 ± 0.33
Statistical analysis
  • Pecan Group vs Usual Care Group · Regression, Linear · Mean difference (net): 0.08 · 95% CI -1.17 to 1.33adjusted for outcome baseline value, age (years), sex (male or female) and BMI (kg/m2)
SecondaryLDL-cholesterol Concentration

Assessed from fasting blood draw expressed in mg/dL

Time frame:
12 weeks
Reported as:
Least squares mean · mg/dL
LDL-cholesterol Concentration
mg/dLPecan GroupUsual Care Group
LDL-cholesterol Concentration110 ± 1.35117 ± 1.26
Statistical analysis
  • Pecan Group vs Usual Care Group · Regression, Linear · Mean difference (net): -7.2 · 95% CI -12.3 to -2.1adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)
SecondaryHDL-cholesterol Concentration

Assessed from fasting blood draw expressed in mg/dL

Time frame:
12 weeks
Reported as:
Least squares mean · mg/dL
HDL-cholesterol Concentration
mg/dLPecan GroupUsual Care Group
HDL-cholesterol Concentration54 ± 0.4753 ± 0.44
Statistical analysis
  • Pecan Group vs Usual Care Group · Regression, Linear · Mean difference (net): 1.1 · 95% CI -0.8 to 2.9adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)
SecondaryTriglycerides

Assessed from fasting blood draw expressed in mg/dL

Time frame:
12 weeks
Reported as:
Geometric least squares mean · mg/dL
Triglycerides
mg/dLPecan GroupUsual Care Group
Triglycerides97.7 (92.6 to 103)108 (103 to 114)
Statistical analysis
  • Pecan Group vs Usual Care Group · Regression, Linear · Mean difference (net): -16.4 · 95% CI -30.0 to -2.9adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)
SecondaryLDL 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
Reported as:
Geometric least squares mean · nmol/L
LDL Lipoprotein Subclasses
nmol/LPecan GroupUsual Care Group
Large281 (249 to 317)252 (225 to 281)
Total1248 (1216 to 1280)1304 (1273 to 1336)
Statistical analysis
  • Pecan Group vs Usual Care Group · Regression, Linear · Mean difference (net): -75.3 · 95% CI -144 to -6.93adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)
  • Pecan Group vs Usual Care Group · Regression, Linear · Mean difference (net): -27.9 · 95% CI -69.3 to 13.4adjustment for the baseline value, age (years), sex (male or female) and body mass index (BMI) (kg/m2)
SecondaryHDL 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
Reported as:
Least squares mean · μmol/L
HDL Lipoprotein Subclasses
μmol/LPecan GroupUsual Care Group
Medium4.1 ± 0.14.4 ± 0.1
Small14.1 ± 0.214.3 ± 0.2
Total21.0 ± 0.1721.0 ± 0.16
Statistical analysis
  • Pecan Group vs Usual Care Group · Regression, Linear · Mean difference (net): 0.10 · 95% CI -0.56 to 0.75adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2).
  • Pecan Group vs Usual Care Group · Mean difference (net): 0.03 · 95% CI -0.75 to 0.80Adjusted for baseline value, age, sex, and BMI
  • Pecan Group vs Usual Care Group · Regression, Linear · Mean difference (net): -0.33 · 95% CI -0.85 to 0.19Adjusted for baseline value, age, sex, and BMI
SecondaryBrachial Systolic and Diastolic Blood Pressure

Blood pressure measured assessed using a SphygmoCor Xcel (Atcor Medical)

Time frame:
12 weeks
Reported as:
Least squares mean · mmHg
Brachial Systolic and Diastolic Blood Pressure
mmHgPecan GroupUsual Care Group
Systolic125 ± 0.81125 ± 0.77
Diastolic79 ± 0.5079 ± 0.47
Statistical analysis
  • Pecan Group vs Usual Care Group · Regression, Linear · Mean difference (final values): 0.02 · 95% CI -3.09 to 3.13were adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)
  • Pecan Group vs Usual Care Group · Regression, Linear · Mean difference (net): 0.20 · 95% CI -1.67 to 2.07Adjusted for baseline value, age, sex, BMI
SecondaryCentral Systolic and Diastolic Blood Pressure

Blood pressure measured assessed using a SphygmoCor Xcel (Atcor Medical)

Time frame:
12 weeks
Reported as:
Least squares mean · mmHg
Central Systolic and Diastolic Blood Pressure
mmHgPecan GroupUsual Care Group
Systolic114 ± 0.70115 ± 0.69
Diastolic80 ± 0.5080 ± 0.48
Statistical analysis
  • Pecan Group vs Usual Care Group · Regression, Linear · Mean difference (net): -0.48 · 95% CI -3.24 to 2.28Adjusted for baseline value, age, sex, BMI
  • Pecan Group vs Usual Care Group · Regression, Linear · Median difference (net): 0.21 · 95% CI -1.69 to 2.10Adjusted for baseline value, age, sex, BMI
SecondaryCarotid-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
Reported as:
Mean · m/s
Carotid-femoral Pulse Wave Velocity
m/sPecan GroupUsual Care Group
Carotid-femoral Pulse Wave Velocity7.1 ± 1.37.3 ± 1.3
Statistical analysis
  • Pecan Group vs Usual Care Group · Regression, Linear · Mean difference (net): -0.01 · 95% CI -0.26 to 0.24were adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)
SecondaryAugmentation 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
Reported as:
Least squares mean · percentage of aortic pulse pressure
Augmentation Index@75bpm
percentage of aortic pulse pressurePecan GroupUsual Care Group
Augmentation Index@75bpm21 ± 0.6522 ± 0.65
Statistical analysis
  • Pecan Group vs Usual Care Group · Regression, Linear · Mean difference (net): -1.65 · 95% CI -4.25 to 0.95adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)
SecondaryFasting Plasma Glucose Concentration

Fasting blood glucose assessed by blood draw and expressed in mg/dL

Time frame:
12 weeks
Reported as:
Least squares mean · mg/dL
Fasting Plasma Glucose Concentration
mg/dLPecan GroupUsual Care Group
Fasting Plasma Glucose Concentration97.7 ± 0.4896.7 ± 0.45
Statistical analysis
  • Pecan Group vs Usual Care Group · Regression, Linear · Mean difference (net): 1.2 · 95% CI -0.6 to 3.0adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)
SecondarySerum Insulin Concentration

Fasting serum insulin levels assessed by blood draw and expressed in micro IU/m

Time frame:
12 weeks
Reported as:
Geometric least squares mean · μIU/mL
Serum Insulin Concentration
μIU/mLPecan GroupUsual Care Group
Serum Insulin Concentration8.42 (7.92 to 8.95)8.33 (7.87 to 8.83)
Statistical analysis
  • Pecan Group vs Usual Care Group · Regression, Linear · Mean difference (net): -0.4 · 95% CI -2.3 to 1.6adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2).
SecondaryHbA1c

HbA1c assessed in whole blood collected during fasting

Time frame:
12-weeks
Reported as:
Least squares mean · percentage of glycated hemoglobin
HbA1c
percentage of glycated hemoglobinPecan GroupUsual Care Group
HbA1c5.53 ± 0.015.49 ± 0.01
Statistical analysis
  • Pecan Group vs Usual Care Group · Regression, Linear · Mean difference (net): 0.0 · 95% CI 0.0 to 0.1adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2).
SecondaryDiet 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
Reported as:
Least squares mean · scores on a scale
Diet Quality: Healthy Eating Index 2020
scores on a scalePecan GroupUsual Care Group
Diet Quality: Healthy Eating Index 202060.8 ± 1.151.5 ± 1.0
Statistical analysis
  • Pecan Group vs Usual Care Group · Mixed Models Analysis · Mean difference (net): 9.4 · 95% CI 5.0 to 13.7adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2).
SecondaryTotal Cholesterol Concentration

Assessed from fasting blood draw expressed in mg/dL

Time frame:
12-weeks
Reported as:
Mean · mg/dL
Total Cholesterol Concentration
mg/dLPecan GroupUsual Care Group
Total Cholesterol Concentration185 ± 1.69193 ± 1.59
Statistical analysis
  • Pecan Group vs Usual Care Group · Regression, Linear · Median difference (net): -8.1 · 95% CI -14.5 to -1.7adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)
SecondaryLDL 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
Reported as:
Least squares mean · nmol/L
LDL Subclasses
nmol/LPecan GroupUsual Care Group
Medium297 ± 20.2337 ± 19.1
Small684 ± 24.5677 ± 23.2
Statistical analysis
  • Pecan Group vs Usual Care Group · Regression, Linear · Mean difference (net): -25.5 · 95% CI -98.6 to 47.5adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)
  • Pecan Group vs Usual Care Group · Regression, Linear · Mean difference (net): 1.86 · 95% CI -91.8 to 95.5adjustment for the baseline value, age (years), sex (male or female) and body mass index (BMI) (kg/m2)
SecondaryHDL 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
Reported as:
Geometric mean · μmol/L
HDL Subclass-Large
μmol/LPecan GroupUsual Care Group
HDL Subclass-Large2.2 (2.0 to 2.3)2.0 (1.8 to 2.1)
Statistical analysis
  • Pecan Group vs Usual Care Group · Regression, Linear · Mean difference (net): 0.35 · 95% CI 0.07 to 0.63adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2).
Other pre-specifiedChange in the Composition of the Gut Microbiota

Abundance measured using 16 s rRNA sequencing

Time frame:
12 weeks

Results for this outcome have not been posted.

Adverse events

Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Pecan Group0/69 (0%)0/69 (0%)2/69 (2.9%)
Usual Care Group0/69 (0%)0/69 (0%)0/69 (0%)
Most frequent other events
Most frequent other events
EventPecan GroupUsual Care Group
AppendectomyGastrointestinal disorders1/690/69
Gastric resectionGastrointestinal disorders1/690/69

Baseline characteristics

Age, Continuous
Age, Continuous(years)Pecan GroupUsual Care GroupTotal
Mean46 ± 1246 ± 1446 ± 13
Sex: Female, Male
Sex: Female, Male(Participants)Pecan GroupUsual Care GroupTotal
Female453681
Male243357
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Pecan GroupUsual Care GroupTotal
Count of participants——0
Region of Enrollment
Region of Enrollment(participants)Pecan GroupUsual Care GroupTotal
United States6969138
Weight
Weight(kg)Pecan GroupUsual Care GroupTotal
Mean84.3 ± 12.585.2 ± 14.384.8 ± 13.4
Waist circumference
Waist circumference(cm)Pecan GroupUsual Care GroupTotal
Mean97.2 ± 8.898.8 ± 10.898.0 ± 9.9
Pulse wave velocity
Pulse wave velocity(m/s)Pecan GroupUsual Care GroupTotal
Mean7.1 ± 1.37.2 ± 1.27.2 ± 1.3
Flow mediated dilation
Flow mediated dilation(percent point change in arterial diamete)Pecan GroupUsual Care GroupTotal
Mean7.2 ± 4.06.1 ± 3.36.6 ± 3.7

13 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Penn State University
    University Park, Pennsylvania 16802, United States
09

References and documents

Publications

  • 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. PubMed 40386548 ↗
  • 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. PubMed 40113170 ↗
  • 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. PubMed 39880306 ↗

Study documents

  • Study protocol · Sep 19, 2023
  • Statistical analysis plan · Sep 19, 2023
  • Informed consent form · Apr 22, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2022 to primary completion in Mar 2024, 18 months.

Results were first posted in Feb 2025, 11 months after primary completion.

Of 54 non-industry phase 2 interventional studies under Cardiovascular Diseases, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 73. This study's 18 months is below that.

Counting every sponsor, half of 76 studies reached it within 28 months; a quarter within 18 and three quarters within 57.

Cardiovascular Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 28, 2021
First posted
Oct 8, 2021
StartActual
Aug 15, 2022
Primary completionActual
Mar 1, 2024
CompletionActual
Mar 1, 2024
Results first posted
Feb 25, 2025
Last update
Feb 25, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05071807
Lead sponsor
Penn State University
Collaborators
American Pecan Council
Responsible party
Kristina Petersen PhD, APD, FAHA (Associate Professor, Penn State University) — Principal investigator
First posted
Oct 8, 2021
Start date
Aug 15, 2022
Primary completion
Mar 1, 2024
Completion
Mar 1, 2024
Results posted
Feb 25, 2025
Last update
Feb 25, 2025

Study contacts

Kristina Petersen, PhD
principal investigator · Penn State University

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Pecan nut

Other studies in this condition

Cardiovascular Diseases →

Other studies from this sponsor

Penn State University →

Start the discussion