Effects of pecan consumption on heart health
Dose Response Effects of Pecan Consumption
NA · University of Georgia · NCT05949879
This study is testing how eating different amounts of pecans can improve heart health in adults who are at risk for heart disease.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 30 Years to 75 Years |
| Sex | All |
| Sponsor | University of Georgia (other) |
| Locations | 1 site (Athens, Georgia) |
| Trial ID | NCT05949879 on ClinicalTrials.gov |
What this trial studies
This study investigates how different amounts of pecan consumption affect blood lipids and overall health in adults at risk for cardiovascular disease. Participants will consume pecans as a percentage of their total energy needs, specifically at doses of 6%, 13%, and 20%. The study aims to determine the minimal effective dose of pecans that can improve metabolic and cardiovascular outcomes. It is a single-blinded, randomized control trial designed to provide insights into the relationship between pecan intake and health markers.
Who should consider this trial
Good fit: Ideal candidates are adults aged 30 to 75 with elevated cholesterol levels or overweight/obesity.
Not a fit: Patients with familial hypercholesterolemia or those with significantly high cholesterol levels may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to dietary recommendations that improve heart health and reduce cardiovascular disease risk.
How similar studies have performed: Previous studies have shown positive effects of nut consumption on cardiovascular health, but this specific dose-response approach is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Athens, Georgia
- University of Georgia — Athens, Georgia, United States (RECRUITING)
Study contacts
- Principal investigator: Jamie A Cooper, Ph.D. — University of Georgia
- Study coordinator: Jamie A Cooper, Ph.D.
- Email: jamie.cooper@uga.edu
- Phone: 706-542-4378
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Dyslipidemias, Overweight and Obesity, Nutrition, Healthy