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NCT05071807 | Completed | Cardiovascular Diseases

Cardiometabolic Effects of Pecans as a Snack
Sponsor:

Penn State University

Information provided by (Responsible Party):

Kristina Petersen PhD, APD, FAHA

Brief Summary:

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.

Condition or disease

Cardiovascular Diseases

Intervention/treatment

Pecans

Usual Care

Phase

Phase 2

Detailed 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.}}

Study Type : Interventional
Estimated Enrollment : 138 participants
Masking : Double
Primary Purpose : Prevention
Official Title : Cardiometabolic Effects of Including Pecans as a Snack to Improve Diet Quality: a Randomized Controlled Study
Actual Study Start Date : August 15, 2022
Estimated Primary Completion Date : March 1, 2024
Estimated Study Completion Date : March 1, 2024
Arm Intervention/treatment

Active Comparator: Pecan Group

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

Drug: Pecans

Active Comparator: Usual Care Group

Participants will consume their usual diet devoid of nuts

Other: Usual Care
Ages Eligible for Study: 25 Years to 70 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
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
Cardiometabolic Effects of Pecans as a Snack

Location Details

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Cardiometabolic Effects of Pecans as a Snack

How to Participate

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Locations

Not yet recruiting

United States, Pennsylvania

Penn State University

University Park, Pennsylvania, United States, 16802