The Ability of Pecan Consumption to Improve Vascular Function and Reduce Chronic Disease Risk in Aging Adults
- Conditions
- Aging
- Interventions
- Dietary Supplement: PECAN
- Registration Number
- NCT04385537
- Lead Sponsor
- University of Georgia
- Brief Summary
Background: To date, there are no published studies on the effects of pecans on vascular function following a high-fat meal.
Purpose: To examine the impact of daily pecan consumption for a 4-week period on vascular health and other markers of cardiovascular disease risk in aging adults.
- Detailed Description
This will be a randomized, controlled trial in men and postmenopausal women (50-75y). Subjects will be randomized into one of the two study groups: a control group (CON) following their usual diet, or intervention group (PECAN) following their usual diet but also consuming 68g/day of pecans as a snack.
There will be 3 visits: A Screening visit and a baseline and post-diet intervention visit (4-weeks). Anthropometrics, questionnaires, a fasting blood sample, and fasting vascular measures will be collected at each visit. Subjects will participate in a saturated fatty acid meal challenge in which additional blood, vascular measurements will be collected.
Hypothesis: Daily pecan consumption will result in improved fasting blood lipids, vascular measures, antioxidant status, and appetite compared to the control group. Additionally, also the PECAN group will result in improved postprandial blood lipids and vascular measures compared to the control group.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- Men and postmenopausal women (without menses for 1 yr and follicle stimulating hormone > 30 IU/mL) between the ages of 50-75y
- Body mass indexes (BMI) between 18-34.9kg/m2
- Nut consumption >2 servings/week or tree nut butter consumption >3 servings/week
- Pre-menopausal and menopausal women, hormone replacement therapy if less than 2 years
- Regularly exercise more than 3 h/week
- Weight gain or loss more than 5% of their body weight in the past 3 months
- Plans to begin a weight loss/exercise regimen during the trial
- Gastrointestinal surgeries, conditions or disorders
- History of medical or surgical events that could affect swallowing
- Chronic or metabolic diseases
- Previous MI, stroke, or cancer
- Fasting blood glucose levels greater than 126 mg/dL
- Blood pressure greater than 180/120 mmHg
- Medication use affecting digestion and absorption, metabolism
- Lipid-lowering medications
- Medications for diabetes, depression, or ADD/ADHD
- Regular use of medications known to affect endothelial function or blood vessel tone
- Blood pressure medication and steroid/hormone therapies
- Individuals on a medically prescribed or special diet
- Individuals with food allergies to foods specifically in the study
- Excessively use alcohol (greater than 3 drinks/d for men; greater than 2 drinks/d for women)
- Tobacco or nicotine use
- Individuals taking fish oil and omega-3 fatty acid supplements
- Significant head trauma or brain surgery
- A score >26 on the Beck's Depression Inventory II (BDI-II)
- A score <24 on the Mini-Mental State Examination (MMSE) will be excluded.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PECAN PECAN Participants in this group consume 68 g of pecans/d with no other changes to their habitual diet and avoid all other nuts.
- Primary Outcome Measures
Name Time Method Change in fasting and postprandial Flow-Mediated Dilation from baseline to 4 weeks Baseline and 4 weeks Flow-Mediated Dilation %
Change in fasting and postprandial vessel diameter from baseline to 4 weeks Baseline and 4 weeks baseline diameter (mm) and peak dilation (mm)
Change in fasting and postprandial reactive hyperemia velocity from baseline to 4 weeks Baseline and 4 weeks Baseline velocity (cm/s) and reactive hyperemia velocity (cm/s)
Change in fasting and postprandial shear rate from baseline to 4 weeks Baseline and 4 weeks baseline shear rate (sec.-1) and reactive hyperemia shear rate (sec.-1)
Change in fasting and postprandial Continuous-Wave Near-Infrared Spectrometry from baseline to 4 weeks Baseline and 4 weeks O2 desaturation rate (%.sec-1), and O2 resaturation rate (%.sec-1)
- Secondary Outcome Measures
Name Time Method Change in baseline weight at 4 weeks Baseline and 4 weeks weight (kg)
Change in baseline waist and hip circumference Baseline and 4 weeks waist and hip circumference (cm)
Change in fasting blood lipids from baseline to 4 weeks Baseline and 4 weeks Total cholesterol (mg/dL), high-density lipoprotein (HDL) cholesterol (mg/dL), triglycerides (mg/dL), low-density lipoprotein (LDL) cholesterol (mg/dL), apolipoprotein B (mg/dL)
Change in fasting and postprandial hunger and satiety from baseline to 4 weeks Baseline and 4 weeks Hunger, fullness, prospective consumption, and desire to eat measured via a Visual Analog Scale (VAS) (mm). The range of scores on the continuous VAS is between 0mm (no hunger, fullness, prospective consumption and desire to eat) and 100mm (the greatest feeling of hunger, fullness, prospective consumption and desire to eat)
Change in blood pressure from baseline to 4 weeks Baseline and 4 weeks Systolic and Diastolic Blood Pressure (mm Hg)
Change in baseline total body fat percentage at 4 weeks Baseline and 4 weeks total body fat percentage (%)
Change in fasting and postprandial insulin from baseline to 4 weeks Baseline and 4 weeks Insulin (uU/mL)
Change in fasting and postprandial antioxidants from baseline to 4 weeks Baseline and 4 weeks Total antioxidant capacity (uM trolox equivalents) measured via Oxygen Radical Absorbance Capacity (ORAC)
Change in fasting and postprandial lipid peroxidation from baseline to 4 weeks Baseline and 4 weeks Malondialdehyde (MDA) (uM) measured via Thiobarbituric acid reactive substances (TBARS) assay.
Change in fasting inflammation from baseline to 4 weeks Baseline and 4 weeks Interleukin-6 (pg/mL), C-reactive Protein (pg/mL), Tumor Necrosis Factor-α (pg/mL), Plasminogen Activator-1 (pg/mL)
Change in fasting and postprandial glucose and triglycerides from baseline to 4 weeks Baseline and 4 weeks Glucose (mg/dL) and triglycerides (mg/dL)
Change in fasting and postprandial peptide YY, cholecystokinin (CCK), and ghrelin from baseline to 4 weeks Baseline and 4 weeks Peptide YY (pg/mL), CCK (pg/mL), ghrelin (pg/mL)
Change in fasting and postprandial non-esterified free fatty acids (NEFA) from baseline to 4 weeks Baseline and 4 weeks NEFA (mEq/L)
Trial Locations
- Locations (1)
University of Georgia- Department of Foods and Nutrition
🇺🇸Athens, Georgia, United States