Cardiometabolic Effects of Pecans as a Snack

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Drug: Pecans
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pecan Group<br>Participants will consume their usual diet, but replace one snack with unsalted raw pecans incorporated as a snack | Drug: Pecans<br>* Participants will receive 2 oz of pecans daily to replace a typical snack and continue consuming their usual diet for 12 weeks.<br>|
| Active Comparator: Usual Care Group<br>Participants will consume their usual diet devoid of nuts | Other: Usual Care<br>* Participants will receive grocery vouchers and continue consuming their usual diet for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flow Mediated Dilation | Measured by brachial ultrasound and expressed as percent artery dilation | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL-cholesterol concentration | Assessed from fasting blood draw expressed in mg/dL | 12 weeks | 
| HDL-cholesterol concentration | Assessed from fasting blood draw expressed in mg/dL | 12 weeks | 
| Triglycerides | Assessed from fasting blood draw expressed in mg/dL | 12 weeks | 
| LDL lipoprotein subclasses | Assessed from fasting blood draw expressed in nmol/L | 12 weeks | 
| HDL lipoprotein subclasses | Assessed from fasting blood draw expressed in umol/L | 12 weeks | 
| Brachial systolic and diastolic blood pressure | Blood pressure measured assessed using a SphymoCor Ecel (Atcor Medical) | 12 weeks | 
| Central systolic and diastolic blood pressure | Blood pressure measured assessed using a SphymoCor Ecel (Atcor Medical) | 12 weeks | 
| Carotid-femoral pulse wave velocity | A measure of arterial stiffness assessed using a SphymoCor Ecel (Atcor Medical). Expressed in meters/second. | 12 weeks | 
| Augmentation Index | A measure of arterial stiffness assessed using a SphymoCor Ecel (Atcor Medical). Expressed as a percentage. A higher percentage value is indicative of greater arterial stiffness. | 12 weeks | 
| Fasting plasma glucose concentration | Fasting blood glucose assessed by blood draw and expressed in mg/dL | 12 weeks | 
| Serum insulin concentration | Fasting serum insulin levels assessed by blood draw and expressed in micro IU/m | 12 weeks | 
| HbA1c | HbA1c assessed in whole blood and expressed in micro IU/mL | 12-weeks | 
| Diet quality: Healthy Eating Index 2015 | Diet quality measured by 24-hour recalls will be assessed using HEI-2015 | 12-weeks | 
| Total Cholesterol concentration | Assessed from fasting blood draw expressed in mg/dL | 12-weeks |