Cardiovascular DiseasesPhase 2NCT05071807
Cardiometabolic Effects of Pecans as a Snack
A Phase 2 study testing Pecans in people with Cardiovascular Diseases, run by Penn State University at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Pecans
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2022to 1 Mar 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State University
University Park, Pennsylvania, 16802
About this study
Official title: Cardiometabolic Effects of Including Pecans as a Snack to Improve Diet Quality: a Randomized Controlled Study
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.
- Conditions
- Cardiovascular Diseases
- Being tested
- Pecans, Usual Care
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PecansDrug
Participants will receive 2 oz of pecans daily to replace a typical snack and continue consuming their usual diet for 12 weeks.
Usual CareOther
Participants will receive grocery vouchers and continue consuming their usual diet for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Pecan Group | Active comparator | Participants will consume their usual diet, but replace one snack with unsalted raw pecans incorporated as a snack Receives: Drug: Pecans |
| Usual Care Group | Active comparator | Participants will consume their usual diet devoid of nuts Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow Mediated Dilation
Measured by brachial ultrasound and expressed as percentage points of change in arterial diameter
Measured: 12 weeks
Secondary outcomes (16)
LDL-cholesterol Concentration
Assessed from fasting blood draw expressed in mg/dL
Measured: 12 weeks
HDL-cholesterol Concentration
Assessed from fasting blood draw expressed in mg/dL
Measured: 12 weeks
Triglycerides
Assessed from fasting blood draw expressed in mg/dL
Measured: 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.
Measured: 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.
Measured: 12 weeks
Brachial Systolic and Diastolic Blood Pressure
Blood pressure measured assessed using a SphygmoCor Xcel (Atcor Medical)
Measured: 12 weeks
Central Systolic and Diastolic Blood Pressure
Blood pressure measured assessed using a SphygmoCor Xcel (Atcor Medical)
Measured: 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
Measured: 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.
Measured: 12 weeks
Fasting Plasma Glucose Concentration
Fasting blood glucose assessed by blood draw and expressed in mg/dL
Measured: 12 weeks
Serum Insulin Concentration
Fasting serum insulin levels assessed by blood draw and expressed in micro IU/m
Measured: 12 weeks
HbA1c
HbA1c assessed in whole blood collected during fasting
Measured: 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.
Measured: 12-weeks
Total Cholesterol Concentration
Assessed from fasting blood draw expressed in mg/dL
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start15 Aug 2022
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- American Pecan Council
- Responsible party
- Principal investigator, Kristina Petersen PhD, APD, FAHA, Penn State University
- Investigators
- Kristina Petersen, PhD, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05071807
- Sponsor's protocol ID
- PKE PECAN
- Status last verified
- Feb 2025
- First submitted
- 28 Sep 2021
- Last updated
- 25 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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 40386548Hart 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 40113170Hart 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 at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiometabolic Effects of Including Pecans as a Snack to Improve Diet Quality: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05071807
- Acronym / sponsor ID
- PKE PECAN
- Conditions
- Cardiovascular Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- American Pecan Council
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 8 Oct 2021 (actual)
- Results
- Posted 25 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pecan Group | Active comparator | Drug: PecansParticipants will consume their usual diet, but replace one snack with unsalted raw pecans incorporated as a snack |
| Usual Care Group | Active comparator | Other: Usual CareParticipants will consume their usual diet devoid of nuts |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PecansParticipants will receive 2 oz of pecans daily to replace a typical snack and continue consuming their usual diet for 12 weeks. | Drug | Pecan Group |
| Usual CareParticipants will receive grocery vouchers and continue consuming their usual diet for 12 weeks. | Other | Usual Care Group |
Primary outcome
Flow Mediated Dilation
Time frame: 12 weeks
Measured by brachial ultrasound and expressed as percentage points of change in arterial diameter
16 secondary outcomes
LDL-cholesterol Concentration
Time frame: 12 weeks
HDL-cholesterol Concentration
Time frame: 12 weeks
Triglycerides
Time frame: 12 weeks
LDL Lipoprotein Subclasses
Time frame: 12 weeks
HDL Lipoprotein Subclasses
Time frame: 12 weeks
Brachial Systolic and Diastolic Blood Pressure
Time frame: 12 weeks
Central Systolic and Diastolic Blood Pressure
Time frame: 12 weeks
Carotid-femoral Pulse Wave Velocity
Time frame: 12 weeks
Augmentation Index@75bpm
Time frame: 12 weeks
Fasting Plasma Glucose Concentration
Time frame: 12 weeks
Serum Insulin Concentration
Time frame: 12 weeks
HbA1c
Time frame: 12-weeks
Diet Quality: Healthy Eating Index 2020
Time frame: 12-weeks
Total Cholesterol Concentration
Time frame: 12-weeks
LDL Subclasses
Time frame: 12 weeks
HDL Subclass-Large
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40386548Hart 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.
- Derived from this study: PubMed 40113170Hart 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.
- Derived from this study: PubMed 39880306Hart 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristina Petersen, PhD principal investigator
Penn State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pecans in people with Cardiovascular Diseases, run by Penn State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flow Mediated Dilation (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05071807, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.