Cardiometabolic Effects of Pecans as a Snack

Penn State University138 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

138

Conditions

Cardiovascular Diseases

Interventions

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.

Eligibility

Sex: ALLMin age: 25 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Penn State University

University Park, Pennsylvania, United States

Outcomes

Primary Outcomes

Flow Mediated Dilation

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

Time frame: 12 weeks

Secondary Outcomes

LDL-cholesterol Concentration

Assessed from fasting blood draw expressed in mg/dL

Time frame: 12 weeks

HDL-cholesterol Concentration

Assessed from fasting blood draw expressed in mg/dL

Time frame: 12 weeks

Triglycerides

Assessed from fasting blood draw expressed in mg/dL

Time frame: 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.

Time frame: 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.

Time frame: 12 weeks

Brachial Systolic and Diastolic Blood Pressure

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

Time frame: 12 weeks

Data from ClinicalTrials.gov

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