80 Participants Needed

Pecan Consumption for Cardiometabolic Health

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

Trial Summary

What is the purpose of this trial?

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. The specific aims of this study are to: * Examine the effect of pecan consumption at doses of 6%, 13%, and 20% of total energy needs on fasting and postprandial blood lipids. * Examine the effect of pecan consumption at doses of 6%, 13%, and 20% of total energy needs on plasma markers associated with overall health. * Examine the effect of pecan consumption at doses of 6%, 13%, and 20% of total energy needs on subjective and physiologic postprandial measures of hunger and satiety. Participants will be asked to: * Consume pecans daily for 28 days or maintain their current habitual diet. * Attend three short weekly visits for fasting blood craws, body measurements, and collect their next week's supply of study materials. * Attend two longer (5 h) testing visits which include consuming a standard breakfast meal and having their blood drawn periodically before and after breakfast. Researchers will compare pecan LOW, pecan MID, pecan HIGH, and the Control group to examine the physiologic effects of incorporating various dosages of pecans into one's diet.

Will I have to stop taking my current medications?

Yes, you may need to stop taking certain medications. The trial excludes participants using medications that affect digestion, absorption, metabolism, lipid levels, diabetes, blood thinning, and steroid/hormone therapies.

What data supports the effectiveness of this treatment for cardiometabolic health?

Research shows that a diet rich in pecans can improve markers related to heart and metabolic health, such as lowering bad cholesterol and improving insulin function, in people who are overweight or at risk for heart disease.12345

Is pecan consumption safe for humans?

Research suggests that consuming pecans is generally safe for humans and may even improve heart health by lowering cholesterol and other risk factors for heart disease.12367

How does pecan consumption as a treatment for cardiometabolic health differ from other treatments?

Pecan consumption is unique because it involves eating a natural food rich in healthy fats, which can improve heart health by lowering bad cholesterol and improving insulin function, unlike many standard treatments that may rely on medications.128910

Research Team

JA

Jamie A Cooper, Ph.D.

Principal Investigator

University of Georgia

Eligibility Criteria

This trial is for men and women aged 30-75 with overweight or obesity (BMI >28 kg/m2) and elevated cholesterol levels. It's not for those planning to change their diet/exercise, with food allergies to nuts/gluten/dairy, on special diets like keto or vegetarian, using certain medications, smokers, pregnant/lactating women, or with a history of serious health conditions.

Inclusion Criteria

You are significantly above a healthy weight based on your body mass index (BMI).
My cholesterol levels are borderline high or at risk in two or more categories, or high in any.
I am between 30 and 75 years old with high cholesterol or I am overweight.

Exclusion Criteria

Your blood pressure is higher than 180/120 mmHg.
You smoke or use nicotine products.
I have a history of issues that could affect my digestion or swallowing.
See 17 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week
1 visit (in-person)

Pre-intervention

Participants undergo baseline measurements and a high-saturated-fat meal challenge

1 day
1 visit (in-person)

Dietary Intervention

Participants consume pecans daily for 28 days or maintain their current habitual diet

4 weeks
3 short weekly visits (in-person), 2 longer testing visits (in-person)

Post-intervention

Participants undergo post-intervention measurements and repeat the high-saturated-fat meal challenge

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

Treatment Details

Interventions

  • CONTROL
  • Pecan HIGH
  • Pecan LOW
  • Pecan MID
Trial Overview The study tests the effects of daily pecan consumption at different doses (low, mid, high) compared to no pecans (control) over 28 days. Researchers will monitor changes in blood lipids and markers of hunger/satiety after a standard breakfast meal.
Participant Groups
4Treatment groups
Experimental Treatment
Group I: Pecan MIDExperimental Treatment1 Intervention
Participants are given pecans and instructed on how to substitute study foods into their diet to maintain caloric balance.
Group II: Pecan LOWExperimental Treatment1 Intervention
Participants are given pecans and instructed on how to substitute study foods into their diet to maintain caloric balance.
Group III: Pecan HIGHExperimental Treatment1 Intervention
Participants are given pecans and instructed on how to substitute study foods into their diet to maintain caloric balance.
Group IV: CONTROLExperimental Treatment1 Intervention
Participants are asked to maintain their current habitual diet and avoid any tree nut/peanut consumption for the entire 28-day intervention period.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Georgia

Lead Sponsor

Trials
109
Recruited
43,500+

Findings from Research

A 4-week randomized controlled trial showed that a pecan-rich diet significantly improved serum insulin levels and insulin resistance compared to a control diet in healthy middle-aged and older adults who are overweight or obese.
Pecan consumption also led to a clinically significant reduction in cardiometabolic disease risk, as indicated by improvements in various biomarkers related to cardiovascular disease and type 2 diabetes.
A Pecan-Rich Diet Improves Cardiometabolic Risk Factors in Overweight and Obese Adults: A Randomized Controlled Trial.McKay, DL., Eliasziw, M., Chen, CYO., et al.[2018]
In a study involving 23 participants, a pecan-enriched diet significantly improved serum lipid profiles by reducing total and LDL cholesterol and triglycerides compared to a standard Step I diet, while also increasing HDL cholesterol.
Replacing 20% of a Step I diet with pecans did not lead to weight gain, suggesting that incorporating pecans into a cholesterol-lowering diet can be both effective and safe.
A monounsaturated fatty acid-rich pecan-enriched diet favorably alters the serum lipid profile of healthy men and women.Rajaram, S., Burke, K., Connell, B., et al.[2018]
In a 12-week randomized clinical trial involving 204 patients with stable coronary artery disease, adding 30 g of pecan nuts to a healthy diet significantly reduced non-HDL cholesterol and improved the total cholesterol/HDL cholesterol ratio compared to a control group and a group receiving extra-virgin olive oil.
While the pecan nut supplementation did not affect LDL cholesterol levels, it suggests potential benefits for other lipid profile markers, indicating that pecans may be a valuable addition to dietary strategies for managing cholesterol in CAD patients.
Effects of a healthy diet enriched or not with pecan nuts or extra-virgin olive oil on the lipid profile of patients with stable coronary artery disease: a randomised clinical trial.Campos, VP., Portal, VL., Markoski, MM., et al.[2021]

References

A Pecan-Rich Diet Improves Cardiometabolic Risk Factors in Overweight and Obese Adults: A Randomized Controlled Trial. [2018]
A monounsaturated fatty acid-rich pecan-enriched diet favorably alters the serum lipid profile of healthy men and women. [2018]
Effects of a healthy diet enriched or not with pecan nuts or extra-virgin olive oil on the lipid profile of patients with stable coronary artery disease: a randomised clinical trial. [2021]
Pecan-enriched diets increase energy expenditure and fat oxidation in adults at-risk for cardiovascular disease in a randomised, controlled trial. [2022]
Effect of pecan nuts and extra-virgin olive oil on glycemic profile and nontraditional anthropometric indexes in patients with coronary artery disease: a randomized clinical trial. [2022]
Tree Nut and Peanut Consumption and Risk of Cardiovascular Disease: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2023]
The pecan nut (Carya illinoinensis) and its oil and polyphenolic fractions differentially modulate lipid metabolism and the antioxidant enzyme activities in rats fed high-fat diets. [2018]
Appetite responses to pecan-enriched diets. [2022]
Pecans lower low-density lipoprotein cholesterol in people with normal lipid levels. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Pecan-Enriched Diets Alter Cholesterol Profiles and Triglycerides in Adults at Risk for Cardiovascular Disease in a Randomized, Controlled Trial. [2023]