Cardiometabolic Effects of Pecans as a Snack

The Pennsylvania State University (PENNSTATE)

Status and phase: Completed; Phase 2

Conditions: Cardiovascular Diseases

Treatments: Drug: Pecans; Other: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT05071807

PKE PECAN

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 138 patients

Sex: All

Ages: 25 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

138 participants in 2 patient groups

Pecan Group

Active Comparator group

Description:

Participants will consume their usual diet, but replace one snack with unsalted raw pecans incorporated as a snack

Treatment:

Drug: Pecans

Usual Care Group

Active Comparator group

Description:

Participants will consume their usual diet devoid of nuts

Treatment:

Other: Usual Care