Cardiometabolic Effects of Pecans as a Snack

NCT05071807 | Completed Phase 2 Results FDA Drug

• 1 other identifier: PKE PECAN
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• Flow Mediated Dilation

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

  12 weeks

Secondary Outcomes (16)

• LDL-cholesterol Concentration

  12 weeks

• HDL-cholesterol Concentration

  12 weeks

• Triglycerides

  12 weeks

• LDL Lipoprotein Subclasses

  12 weeks

• HDL Lipoprotein Subclasses

  12 weeks

Other Outcomes (1)

• Change in the Composition of the Gut Microbiota

  12 weeks

Study Arms (2)

Pecan Group

ACTIVE COMPARATOR

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

Drug: Pecans

Usual Care Group

ACTIVE COMPARATOR

Participants will consume their usual diet devoid of nuts

Other: Usual Care

Interventions

Pecans DRUG

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

Pecan Group

Usual Care OTHER

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

Usual Care Group

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Penn State University: lead
• American Pecan Council: collaborator

Study Sites (1)

Penn State University

University Park, Pennsylvania, 16802, United States

Location

Related Publications (3)

• 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.

  PMID: 40386548 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.

  PMID: 40113170 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.

  PMID: 39880306 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Limitations and Caveats

Increased risk of type 1 statistical error. Dietary data was self-reported.

Results Point of Contact

• Title: DCH Lab
• Organization: Penn State University

dchlab@psu.edu

8148638056

Study Officials

• Kristina Petersen, PhD

  Penn State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: October 8, 2021
• Study Start: August 15, 2022
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: February 25, 2025
• Results First Posted: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)