Overview

Diet Quality, Pecans, and Cardiometabolic Health

Status:
Withdrawn
Trial end date:
2022-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Penn State University
Criteria
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