RECRUITINGINTERVENTIONAL

Dose Response Effects of Pecan Consumption

About 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.

Who May Be Eligible (Plain English)

Who May Qualify: - 30 to 75-year-old men and women at increased risk of cardiovascular disease. Increased risk of cardiovascular disease will be defined by either elevated cholesterol profiles or overweight/obesity. - Elevated cholesterol profiles will be defined as: "Borderline High" and/or "at risk" in two or more of the following variables (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 (between 200-350 mg/dl). - Overweight/obesity will be defined by body mass index (overweight \> 28 kg/m2 or obesity 30 kg/m2 or greater). Who Should NOT Join This Trial: - Probable familial hypercholesterolemia, defined by: total cholesterol greater than 290 mg/dL or LDL levels greater than 190 mg/dL plus a family history of myocardial infarction (MI) before 50 years of age in a 2nd-degree relative or below age 60 in a 1st-degree relative - Alcohol intake \>3 drinks/d for males or \>2 drinks/d for females - Individuals with food allergies/sensitivities to foods provided in the study, including tree nuts, gluten, and or lactose/dairy - Individuals who regularly consume nuts and/or nut butter (defined as consumption of \>2 servings (\~56g) of tree nuts, nuts, or nut butter (e.g., peanut butter, almond butter) per week - Individuals adhering to special diets, including, but not limited to, the ketogenic diet, intermittent fasting, vegetarian diet, or carbohydrate-restricted diets - Plans to begin a weight loss/exercise regime during the trial - Weight gain or loss of more than 5% of their body weight in the past 3 months - History of previous or current renal or bowel disease - Females who are currently pregnant or lactating - Individuals participating in \>3 hours/week of exercise - Women on hormone replacement therapy for \<2 years - Fasting glucose \>126 mg/dL - Blood pressure \>180/120 mmHg ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * 30 to 75-year-old men and women at increased risk of cardiovascular disease. Increased risk of cardiovascular disease will be defined by either elevated cholesterol profiles or overweight/obesity. * Elevated cholesterol profiles will be defined as: "Borderline High" and/or "at risk" in two or more of the following variables (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 (between 200-350 mg/dl). * Overweight/obesity will be defined by body mass index (overweight \> 28 kg/m2 or obesity 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 a family history of myocardial infarction (MI) before 50 years of age in a 2nd-degree relative or below age 60 in a 1st-degree relative * Alcohol intake \>3 drinks/d for males or \>2 drinks/d for females * Individuals with food allergies/sensitivities to foods provided in the study, including tree nuts, gluten, and or lactose/dairy * Individuals who regularly consume nuts and/or nut butter (defined as consumption of \>2 servings (\~56g) of tree nuts, nuts, or nut butter (e.g., peanut butter, almond butter) per week * Individuals adhering to special diets, including, but not limited to, the ketogenic diet, intermittent fasting, vegetarian diet, or carbohydrate-restricted diets * Plans to begin a weight loss/exercise regime during the trial * Weight gain or loss of more than 5% of their body weight in the past 3 months * History of previous or current renal or bowel disease * Females who are currently pregnant or lactating * Individuals participating in \>3 hours/week of exercise * Women on hormone replacement therapy for \<2 years * Fasting glucose \>126 mg/dL * Blood pressure \>180/120 mmHg * History of medical or surgical events that could affect digestion or swallowing * Gastrointestinal surgery, atherosclerosis, or bleeding disorders * Tobacco or nicotine use * Previous heart attack (MI) or stroke, previous or current diagnosis of cancer * Chronic or metabolic diseases * Medication use affecting digestion and absorption, medications affecting metabolism (e.g., thyroid meds), lipid-lowering medications, medications for diabetes, blood thinning medications * Steroid/hormone therapies or current antibiotic cycles

Treatments Being Tested

OTHER

Pecan LOW

Participants are provided with a quantity of pecans that delivers 6% of the participant's estimated energy needs for 28 days.

OTHER

Pecan MID

Participants are provided with a quantity of pecans that delivers 13% of the participant's estimated energy needs for 28 days.

OTHER

Pecan HIGH

Participants are provided with a quantity of pecans that delivers 20% of the participant's estimated energy needs for 28 days.

OTHER

CONTROL

Participants are asked to maintain their current habitual diet and to avoid any tree nut/peanut consumption for the entire 28-day intervention period.

Locations (1)

University of Georgia

Athens, Georgia, United States