Pecans for High Cholesterol

JA
Overseen ByJamie A Cooper, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Cardiovascular disease risk factors, including higher BMIs and poor cholesterol profiles, are on the rise and contribute to the United States' growing disease burden. The bioactive compounds contained in tree nuts have been shown to beneficially affect cardiometabolic health outcomes. Pecans contain more total phenols, sterols, and flavonoids than any other tree nut. They also are a rich source of polyunsaturated fatty acids (PUFAs), fiber, vitamin A, vitamin E, folic acid, calcium, magnesium, phosphorus, potassium, and zinc. These bioactive components in pecans are likely the reason for the previously documented improvements in cardiometabolic health. This study aims to examine the impact of a low dose of pecans on changes in fasting and postprandial lipid metabolism/blood lipids and markers of chronic disease risk.

The specific aims of this study are to:

* Examine the effect of pecan consumption at a dose of 6% of total energy needs for 12 weeks on fasting and postprandial blood lipids.

* Examine the effect of pecan consumption at a dose of 6% of total energy needs for 12 weeks on other markers of chronic disease risk.

Participants will be asked to:

* Consume pecans daily for 12 weeks or maintain their current habitual diet.

* Attend two short visits at 4 and 8 weeks for fasting blood draws, body measurements, and to collect their next 4 weeks' supply of study materials.

* Attend two longer (5 h) testing visits, which include eating a standard breakfast meal and having their blood drawn periodically before and after breakfast.

Researchers will compare the Pecan and Control groups to examine the physiologic effects of incorporating a low dose of pecans into one's diet.

Who Is on the Research Team?

JA

Jamie A Cooper, PhD

Principal Investigator

University of Georgia

Are You a Good Fit for This Trial?

This trial is for people with high cholesterol, obesity (including children), those who have had bariatric surgery, or are interested in healthy nutrition. Participants should be able to eat pecans and attend study visits over 12 weeks.

Inclusion Criteria

Elevated cholesterol profiles defined as 'Borderline High' and/or 'at risk' in two or more of total cholesterol 180-239 mg/dL, LDL cholesterol 110-159 mg/dL, triglycerides 130-199 mg/dL, or 'High' in total cholesterol 240 mg/dL and higher, LDL 160 mg/dL or higher, or triglycerides 200-350 mg/dL
I am 25-75 years old and have high cholesterol or am overweight.
Overweight defined as BMI over 28 kg/m2 or obesity defined as BMI 30 kg/m2 or greater

Exclusion Criteria

Probable familial hypercholesterolemia defined by total cholesterol greater than 290 mg/dL or LDL levels greater than 190 mg/dL plus family history of myocardial infarction before 50 years in 2nd-degree relative or before 60 years in 1st-degree relative
Individuals who regularly exercise more than 3 hours per week
I have a chronic disease like asthma, lung, or kidney disease.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week
1 visit (in-person)

Pre-intervention

Participants undergo baseline measurements including anthropometrics and fasting blood draw

1 day
1 visit (in-person)

Treatment

Participants consume pecans daily for 12 weeks or maintain their current habitual diet

12 weeks
2 short visits at 4 and 8 weeks, 2 longer testing visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Trial Overview

The study compares two groups: one eats a daily amount of pecans equal to about 6% of their calorie needs for 12 weeks, while the other continues their usual diet. Researchers will measure changes in blood fats and disease risk markers.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: PecanExperimental Treatment1 Intervention
Group II: ControlExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Georgia

Lead Sponsor

Trials
109
Recruited
43,500+