Dose Response Effects of Pecan Consumption

Launched by UNIVERSITY OF GEORGIA · Jul 9, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating how different amounts of pecans in the diet can affect heart health and overall well-being in adults aged 30 to 75 who are at risk for heart disease. Researchers want to see how consuming pecans at varying levels—6%, 13%, or 20% of daily food intake—can influence blood fat levels, health markers, and feelings of hunger or fullness. The study aims to understand if eating more pecans can lead to better heart health outcomes.

To participate, you should be between 30 and 75 years old and have either high cholesterol or be overweight. You will need to eat pecans daily for 28 days or stick to your usual diet while attending a few appointments to get your blood tested and have your body measurements taken. If you enjoy nuts and want to learn more about how they might improve your health, this trial could be a good fit!

Gender

ALL

Eligibility criteria

• 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