Diet Quality, Pecans, and Cardiometabolic Health

The Pennsylvania State University (PENNSTATE)

Status and phase: Withdrawn; Phase 2

Conditions: Cardiovascular Diseases

Treatments: Other: Average American Diet devoid of nuts; Drug: Pecan

Study type: Interventional

Funder types: Other

Identifiers

NCT04487808

Pecan

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 25 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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0 participants in 3 patient groups

Average American Diet

Active Comparator group

Description:

Diet representative of average American intake in terms of diet quality measured by the Healthy Eating Index-2015.

Treatment:

Other: Average American Diet devoid of nuts

Average American Diet + Pecans

Active Comparator group

Description:

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.

Treatment:

Drug: Pecan

Healthy Diet + Pecans

Active Comparator group

Description:

High diet quality, measured by Healthy Index-2015 score \>95, and includes 2 oz./day of pecans.

Treatment:

Drug: Pecan