Clinical trial NCT04385537: The Ability of Pecan Consumption to Improve Vascular Function and Reduce Chronic Disease Risk in Aging Adults
Official title: The Ability of Pecan Consumption to Improve Vascular Function and Reduce Chronic Disease Risk in Aging Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Lead sponsor: University of Georgia
Sponsor class: OTHER
Collaborators: name: American Pecan Council
First posted: 2020-05-13
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in fasting and postprandial Flow-Mediated Dilation from baseline to 4 weeks
timeFrame: Baseline and 4 weeks
measure: Change in fasting and postprandial vessel diameter from baseline to 4 weeks
timeFrame: Baseline and 4 weeks
measure: Change in fasting and postprandial reactive hyperemia velocity from baseline to 4 weeks
timeFrame: Baseline and 4 weeks
measure: Change in fasting and postprandial shear rate from baseline to 4 weeks
timeFrame: Baseline and 4 weeks
measure: Change in fasting and postprandial Continuous-Wave Near-Infrared Spectrometry from baseline to 4 weeks
timeFrame: Baseline and 4 weeks
Secondary outcomes:
measure: Change in fasting blood lipids from baseline to 4 weeks
timeFrame: Baseline and 4 weeks
measure: Change in baseline weight at 4 weeks
timeFrame: Baseline and 4 weeks
measure: Change in baseline waist and hip circumference
timeFrame: Baseline and 4 weeks
measure: Change in blood pressure from baseline to 4 weeks
timeFrame: Baseline and 4 weeks
measure: Change in baseline total body fat percentage at 4 weeks
timeFrame: Baseline and 4 weeks
measure: Change in fasting and postprandial insulin from baseline to 4 weeks
timeFrame: Baseline and 4 weeks
measure: Change in fasting and postprandial antioxidants from baseline to 4 weeks
timeFrame: Baseline and 4 weeks
measure: Change in fasting and postprandial lipid peroxidation from baseline to 4 weeks
timeFrame: Baseline and 4 weeks
measure: Change in fasting inflammation from baseline to 4 weeks
timeFrame: Baseline and 4 weeks
measure: Change in fasting and postprandial glucose and triglycerides from baseline to 4 weeks
timeFrame: Baseline and 4 weeks
measure: Change in fasting and postprandial peptide YY, cholecystokinin (CCK), and ghrelin from baseline to 4 weeks
timeFrame: Baseline and 4 weeks
measure: Change in fasting and postprandial non-esterified free fatty acids (NEFA) from baseline to 4 weeks
timeFrame: Baseline and 4 weeks
measure: Change in fasting and postprandial hunger and satiety from baseline to 4 weeks
timeFrame: Baseline and 4 weeks
Other outcomes:
measure: Change in fasting and postprandial composite cognitive function from baseline to 4 weeks
timeFrame: Baseline and 4 weeks. Measured at fasting, and 30 minutes and 3.5 hours postprandial.
measure: Change in fasting and postprandial Cognitive Battery Motivation from baseline to 4 weeks
timeFrame: Baseline and 4 weeks. Measured at fasting, and 30 minutes and 3.5 hours postprandial.
measure: Change in fasting and postprandial NIHTB-CB Flanker Inhibitory Control and Attention Test, and Dimensional Change Card Sort Test from baseline to 4 weeks
timeFrame: Baseline and 4 weeks. Measured at fasting, and 30 minutes and 3.5 hours postprandial.
measure: Change in fasting and postprandial NIHTB-CB Auditory Learning Test, Picture Sequence Memory Task and List Sorting Working Memory Test from baseline to 4 weeks
timeFrame: Baseline and 4 weeks. Measured at fasting, and 30 minutes and 3.5 hours postprandial.
measure: Change in Pittsburg Sleep Quality Index scores from baseline to 4 weeks
timeFrame: Baseline and 4 weeks
measure: Change in State Trait Anxiety Inventory scores from baseline to 4 weeks
timeFrame: Baseline and 4 weeks
Locations:
city: Athens
country: United States
facility: University of Georgia- Department of Foods and Nutrition
state: Georgia
Study officials:
References: