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Completed

NCT Number: NCT05071807

Cardiometabolic Effects of Pecans as a Snack

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.

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Key information

Conditions

Cardiovascular Diseases

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Penn State University

University Park, Pennsylvania, 16802, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pecans

Drug

Participants will receive 2 oz of pecans daily to replace a typical snack and continue consuming their usual diet for 12 weeks.

Usual Care

Other

Participants will receive grocery vouchers and continue consuming their usual diet for 12 weeks.

Primary outcomes

  1. Flow Mediated Dilation

    Time frame: 12 weeks

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

Secondary outcomes

  1. LDL-cholesterol Concentration

    Time frame: 12 weeks

    Assessed from fasting blood draw expressed in mg/dL

  2. HDL-cholesterol Concentration

    Time frame: 12 weeks

    Assessed from fasting blood draw expressed in mg/dL

  3. Triglycerides

    Time frame: 12 weeks

    Assessed from fasting blood draw expressed in mg/dL

  4. LDL Lipoprotein Subclasses

    Time frame: 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.

  5. HDL Lipoprotein Subclasses

    Time frame: 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.

  6. Brachial Systolic and Diastolic Blood Pressure

    Time frame: 12 weeks

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

  7. Central Systolic and Diastolic Blood Pressure

    Time frame: 12 weeks

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

  8. Carotid-femoral Pulse Wave Velocity

    Time frame: 12 weeks

    A measure of arterial stiffness assessed using a SphygmoCor Xcel (Atcor Medical). Expressed in meters/second. Higher values indicate greater arterial stiffness

  9. Augmentation Index@75bpm

    Time frame: 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.

  10. Fasting Plasma Glucose Concentration

    Time frame: 12 weeks

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

  11. Serum Insulin Concentration

    Time frame: 12 weeks

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

  12. HbA1c

    Time frame: 12-weeks

    HbA1c assessed in whole blood collected during fasting

  13. Diet Quality: Healthy Eating Index 2020

    Time frame: 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.

  14. Total Cholesterol Concentration

    Time frame: 12-weeks

    Assessed from fasting blood draw expressed in mg/dL

  15. LDL Subclasses

    Time frame: 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.

  16. HDL Subclass-Large

    Time frame: 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.

Other outcomes

  1. Change in the Composition of the Gut Microbiota

    Time frame: 12 weeks

    Abundance measured using 16 s rRNA sequencing

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Collaborators

  • American Pecan Council

Registry information

Official study title

Cardiometabolic Effects of Including Pecans as a Snack to Improve Diet Quality: a Randomized Controlled Study

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 8, 2021
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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