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Pecans for Cardiovascular Health
Phase 2
Waitlist Available
Research Sponsored by Penn State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Presence of ≥ 1 criterion for metabolic syndrome at screening (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)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study Summary
This trial will examine whether pecans have an effect on markers of peripheral vascular health, lipids and lipoproteins, blood pressure, and glycemic control.
Who is the study for?
This trial is for adults with at least one sign of metabolic syndrome, such as a large waistline or high blood pressure, and a BMI between 25-40. Smokers, pregnant women, those with diabetes or severe hypertension, recent alcohol or antibiotic use are excluded. Also ineligible are individuals with unstable weight, cardiovascular events history, liver/kidney diseases.Check my eligibility
What is being tested?
The study is testing if eating pecans affects heart and blood vessel health compared to usual care without pecans. Participants will be randomly assigned to two groups: one adding pecans to their diet and the other continuing their normal routine.See study design
What are the potential side effects?
Since this trial involves consuming pecans as part of the diet rather than medication, side effects may include potential allergic reactions in those sensitive to nuts or gastrointestinal discomfort.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I meet at least one condition for metabolic syndrome.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Flow Mediated Dilation
Secondary outcome measures
Augmentation Index
Brachial systolic and diastolic blood pressure
Carotid-femoral pulse wave velocity
+11 moreOther outcome measures
Change in the composition of the gut microbiota
Trial Design
2Treatment groups
Active Control
Group I: Pecan GroupActive Control1 Intervention
Participants will consume their usual diet, but replace one snack with unsalted raw pecans incorporated as a snack
Group II: Usual Care GroupActive Control1 Intervention
Participants will consume their usual diet devoid of nuts
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Who is running the clinical trial?
American Pecan CouncilOTHER
2 Previous Clinical Trials
71 Total Patients Enrolled
Penn State UniversityLead Sponsor
357 Previous Clinical Trials
125,849 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have used tobacco products recently or quit less than 6 months ago.My weight has been stable; I haven't lost or gained 10% of it in the last 6 months.I have a history of heart, liver, kidney issues, autoimmune or inflammatory conditions.I am on medication that affects my cholesterol, blood pressure, or blood sugar.I have been diagnosed with an inflammatory condition or have been taking anti-inflammatory medications regularly for the past 3 months.I am taking supplements that may affect the study and I cannot stop.I am a pre-menopausal woman with irregular menstrual cycles.I have not taken antibiotics in the last 8 weeks.I meet at least one condition for metabolic syndrome.I have diabetes.
Research Study Groups:
This trial has the following groups:- Group 1: Pecan Group
- Group 2: Usual Care Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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