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Cardiometabolic Effects of the Recommended Daily Pecan Intake Dose

Cardiometabolic Effects of the Recommended Daily Pecan Intake Dose: A 12-Week Randomized Controlled Trial

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
25 Years to 75 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 5 visits, 2 visits
  • Time periods mentioned: 12 weeks
  • Procedures mentioned: Blood draws, X-rays

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "There are a total of 5 testing visits: screening (v0), pre-intervention (v1), 2 short visits at 4 and 8 weeks (v2, v3), and post-intervention (v4)."
  • "At screening (v0), qualification is confirmed based on anthropometrics and a fasting blood draw, which is analyzed for a cholesterol panel and blood glucose."
  • "At v1, participants will have anthropometrics measured, including body composition by dual-energy x-ray absorptiometry (DXA)."
  • "Fasting and postprandial blood draws for a 4h period will occur following a high saturated-fat meal challenge which delivers 17% of the participant's estimated energy needs. 12-week dietary intervention: The 12-week diet intervention will consist of research personnel providing pecans that deliver 6% of the participant's daily energy needs (determined at V0)."
  • "At these mid-intervention visits, participants also have a fasting blood draw and body measures taken."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

Inclusion Criteria: * 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). 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. * Women on hormone replacement therapy less than 2 years. * 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 * 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 * Atherosclerosis * Previous MI or stroke * Cancer * Fasting blood glucose levels greater than 126 mg/dL * Blood pressure greater than 180/120 mmHg * Medication use affecting digestion, absorption, or metabolism (e.g. thyroid meds), lipid-lowering medications, medications for diabetes, steroid/hormone therapies, or current antibiotic cycles * Medically prescribed or special diets * Food allergies (specific to the foods in the study, including tree nuts, dairy, gluten, palm oil, and coconut oil) * 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 * Anemia or hemoglobin levels \<13.0 g/dL (men) or \<12.5 (women)

Study sites (1)

GA