NCT07696403Not yet recruiting
Cardiometabolic Effects of the Recommended Daily Pecan Intake Dose
Cardiometabolic Effects of the Recommended Daily Pecan Intake Dose: A 12-Week Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 11 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 6 Jul 2026
- Start date
- 1 Mar 2027
- Primary completion date
- 31 Jul 2029
- Lead sponsor
- University of Georgia
- Diseases
- Obesity
- NCT number
- NCT07696403
What you commit to
- Study type: Interventional
- Planned participants: 90
- From 1 Mar 2027 to the primary completion date, 31 Jul 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Women on hormone replacement therapy less than 2 years.
- Previous MI or stroke
Other illness
- History of medical or surgical events that could affect digestion or swallowing
- Gastrointestinal surgeries, conditions, or disorders
- Any chronic diseases (including moderate to severe asthma, chronic lung disease, and kidney disease)
- Metabolic disease
- Cancer
- Medication use affecting digestion, absorption, or metabolism (e.g. thyroid meds), lipid-lowering medications, medications for diabetes, steroid/hormone therapies, or current antibiotic cycles
- Food allergies (specific to the foods in the study, including tree nuts, dairy, gluten, palm oil, and coconut oil)
Lab values
- 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.
- Fasting blood glucose levels greater than 126 mg/dL
- Anemia or hemoglobin levels \<13.0 g/dL (men) or \<12.5 (women)
Other
- Women who are pregnant or nursing
- Individuals who regularly exercise more than 3h/w
- Weight gain or loss of more than 5% body weight in the past 3 months
- Plans to begin a weight loss/exercise regimen during the trial
- Atherosclerosis
- Blood pressure greater than 180/120 mmHg
- Medically prescribed or special diets
- Fish oil supplements
- 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
- Excessive alcohol use (greater than 3 drinks/day for men; greater than 2 drinks/day for women)
- Tobacco or nicotine use
- Underweight BMI (\<18.5 kg/m²)
- Individuals who have donated blood or plasma in the past 2 weeks
Who the study is looking for
- 25-75 year-old men and women at increased risk for cardiovascular disease. Increased risk for 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).
Age in the registry: 25 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Georgia Coordinator of this site? Confirm its status | Athens | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.