Phase 2
N=138
Cardiometabolic Effects of Pecans as a Snack
Cardiovascular Diseases
Bottom Line
View on ClinicalTrials.gov: NCT05071807 ↗Enrolled (actual)
138
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Flow Mediated Dilation — 7.07; 7.25 percent point change in arterial diamete
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Pecans (Drug); Usual Care (Other)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- All
- Sponsor
- Penn State University
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Flow Mediated Dilation |
7.07; 7.25 | — |
| SECONDARY LDL-cholesterol Concentration |
110; 117 | — |
| SECONDARY HDL-cholesterol Concentration |
54; 53 | — |
| SECONDARY Triglycerides |
97.7; 108 | — |
| SECONDARY LDL Lipoprotein Subclasses |
281; 252; 1248; 1304 | — |
| SECONDARY HDL Lipoprotein Subclasses |
4.1; 4.4; 14.1; 14.3; 21.0; 21.0 | — |
| SECONDARY Brachial Systolic and Diastolic Blood Pressure |
125; 125; 79; 79 | — |
| SECONDARY Central Systolic and Diastolic Blood Pressure |
114; 115; 80; 80 | — |
| SECONDARY Carotid-femoral Pulse Wave Velocity |
7.1; 7.3 | — |
| SECONDARY Augmentation Index@75bpm |
21; 22 | — |
| SECONDARY Fasting Plasma Glucose Concentration |
97.7; 96.7 | — |
| SECONDARY Serum Insulin Concentration |
8.42; 8.33 | — |
| SECONDARY HbA1c |
5.53; 5.49 | — |
| SECONDARY Diet Quality: Healthy Eating Index 2020 |
60.8; 51.5 | — |
| SECONDARY Total Cholesterol Concentration |
185; 193 | — |
| SECONDARY LDL Subclasses |
297; 337; 684; 677 | — |
| SECONDARY HDL Subclass-Large |
2.2; 2.0 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT05071807). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.