Diet Quality, Pecans, and Cardiometabolic Health

Phase 2

Withdrawn

• Conditions: Cardiovascular Diseases
• Interventions: Drug: Pecan; Other: Average American Diet devoid of nuts

• Registration Number: NCT04487808
• Lead Sponsor: Penn State University

Brief Summary

A three-period, randomized, crossover controlled feeding trial will be conducted to examine the effect of including 2 oz./day of pecans, as a snack, in a diet representative of average American intake, compared to a diet representative of average American intake devoid of nuts, and a healthy dietary pattern including 2 oz./day of pecans on markers of peripheral vascular health, lipids and lipoproteins, blood pressure, and glycemic control.

Detailed Description

Participants will be randomized to each diet for 4-weeks with a minimum 2-week break between the diet periods. All caloric foods and beverages will be provided. Outcome assessments will be done at baseline and the end of each diet period.

Study Timeline

• Study First Submitted: 2020-07-22
• Study First Submitted QC: 2020-07-22
• Study First Posted: 2020-07-27
• Study Start: 2021-05-01
• Primary Completion: 2022-07-01
• Study Completion: 2022-07-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-15
• Last Update Posted: 2023-08-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• BMI ≥25 and ≤40 kg/m2
• ≥ 1 criterion for metabolic syndrome (i.e. waist circumference ≥ 94 cm men or ≥80 cm women; triglycerides ≥150 mg/dL; HDL ≤ 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.
• non-smoking

Exclusion Criteria

• Current tobacco use or use within the previous 6 months
• Diagnosed diabetes or fasting glucose levels > 126 mg/dL at screening
• Systolic blood pressure >160 mm Hg or diastolic blood pressure > 100 mm Hg at screening.
• Use of anti-hypertensive, lipid lowering, glucose lowering drugs, steroids, or antibiotics in the previous month
• History of a cardiovascular event (heart attack, revascularization, stroke), or heart failure, liver, kidney, autoimmune diseases or inflammatory conditions such as gastrointestinal disorders or rheumatoid arthritis
• Use of supplements and botanicals known to affect study outcomes (e.g. psyllium, fish oil, soy lecithin, and phytoestrogens) and not willing to cease for the duration of the study
• Pregnancy, lactation or planning to become pregnant
• Consumption of >14 alcoholic drinks/week
• Intolerance/allergy/sensitivity to foods included in the study menus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Average American Diet + Pecans	Pecan	Diet that approximates average American intake in terms of diet quality measured by the Healthy Eating Index-2015, but includes 2 oz./day of pecans.
Average American Diet	Average American Diet devoid of nuts	Diet representative of average American intake in terms of diet quality measured by the Healthy Eating Index-2015.
Healthy Diet + Pecans	Pecan	High diet quality, measured by Healthy Index-2015 score \>95, and includes 2 oz./day of pecans.

Primary Outcome Measures

Name	Time	Method
Flow mediated dilation	4 weeks	Measured by brachial ultrasound and expressed as percent artery dilation

Secondary Outcome Measures

Name	Time	Method
Serum insulin concentration	4 weeks	Fasting serum insulin levels assessed by blood draw and expressed in micro IU/mL
LDL-cholesterol concentration	4 weeks	Assessed from fasting blood draw expressed in mg/dL
HDL-cholesterol concentrations	4 weeks	Assessed from fasting blood draw expressed in mg/dL
Triglycerides	4 weeks	Assessed from fasting blood draw expressed in mg/dL
LDL lipoprotein subclasses	4 weeks	Assessed from fasting blood draw expressed in nmol/L
Peripheral systolic and diastolic blood pressure	4 weeks	Blood pressure measured assessed using a SphymoCor Ecel (Atcor Medical)
Central systolic and diastolic blood pressure	4 weeks	Blood pressure measured assessed using a SphymoCor Ecel (Atcor Medical).
HDL lipoprotein subclasses	4 weeks	Assessed from fasting blood draw expressed in umol/L
Carotid-femoral pulse wave velocity	4 weeks	A measure of arterial stiffness assessed using a SphymoCor Ecel (Atcor Medical). Expressed in meters/second.
Augmentation Index	4 weeks	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.
Fasting plasma glucose concentration	4 weeks	Fasting blood glucose assessed by blood draw and expressed in mg/dL