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The Ability of Pecan Consumption to Improve Vascular Function and Reduce Chronic Disease Risk in Aging Adults

Primary Purpose

Aging

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PECAN
Sponsored by
University of Georgia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Aging

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Georgia- Department of Foods and Nutrition

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

PECAN

Arm Description

Participants in this group avoid all nuts for 4-weeks

Participants in this group consume 68 g of pecans/d with no other changes to their habitual diet and avoid all other nuts.

Outcomes

Primary Outcome Measures

Change in fasting and postprandial Flow-Mediated Dilation from baseline to 4 weeks
Flow-Mediated Dilation %
Change in fasting and postprandial vessel diameter from baseline to 4 weeks
baseline diameter (mm) and peak dilation (mm)
Change in fasting and postprandial reactive hyperemia velocity from baseline to 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 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
O2 desaturation rate (%.sec-1), and O2 resaturation rate (%.sec-1)

Secondary Outcome Measures

Change in fasting blood lipids from baseline to 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 baseline weight at 4 weeks
weight (kg)
Change in baseline waist and hip circumference
waist and hip circumference (cm)
Change in blood pressure from baseline to 4 weeks
Systolic and Diastolic Blood Pressure (mm Hg)
Change in baseline total body fat percentage at 4 weeks
total body fat percentage (%)
Change in fasting and postprandial insulin from baseline to 4 weeks
Insulin (uU/mL)
Change in fasting and postprandial antioxidants from baseline to 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
Malondialdehyde (MDA) (uM) measured via Thiobarbituric acid reactive substances (TBARS) assay.
Change in fasting inflammation from baseline to 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
Glucose (mg/dL) and triglycerides (mg/dL)
Change in fasting and postprandial peptide YY, cholecystokinin (CCK), and ghrelin from baseline to 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
NEFA (mEq/L)
Change in fasting and postprandial hunger and satiety from baseline to 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)

Full Information

First Posted
April 30, 2020
Last Updated
May 17, 2022
Sponsor
University of Georgia
Collaborators
American Pecan Council
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1. Study Identification

Unique Protocol Identification Number
NCT04385537
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
September 17, 2020 (Actual)
Primary Completion Date
April 16, 2022 (Actual)
Study Completion Date
April 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Georgia
Collaborators
American Pecan Council

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants in this group avoid all nuts for 4-weeks
Arm Title
PECAN
Arm Type
Experimental
Arm Description
Participants in this group consume 68 g of pecans/d with no other changes to their habitual diet and avoid all other nuts.
Intervention Type
Dietary Supplement
Intervention Name(s)
PECAN
Intervention Description
Raw pecan halves without other changes to their habitual diet.
Primary Outcome Measure Information:
Title
Change in fasting and postprandial Flow-Mediated Dilation from baseline to 4 weeks
Description
Flow-Mediated Dilation %
Time Frame
Baseline and 4 weeks
Title
Change in fasting and postprandial vessel diameter from baseline to 4 weeks
Description
baseline diameter (mm) and peak dilation (mm)
Time Frame
Baseline and 4 weeks
Title
Change in fasting and postprandial reactive hyperemia velocity from baseline to 4 weeks
Description
Baseline velocity (cm/s) and reactive hyperemia velocity (cm/s)
Time Frame
Baseline and 4 weeks
Title
Change in fasting and postprandial shear rate from baseline to 4 weeks
Description
baseline shear rate (sec.-1) and reactive hyperemia shear rate (sec.-1)
Time Frame
Baseline and 4 weeks
Title
Change in fasting and postprandial Continuous-Wave Near-Infrared Spectrometry from baseline to 4 weeks
Description
O2 desaturation rate (%.sec-1), and O2 resaturation rate (%.sec-1)
Time Frame
Baseline and 4 weeks
Secondary Outcome Measure Information:
Title
Change in fasting blood lipids from baseline to 4 weeks
Description
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)
Time Frame
Baseline and 4 weeks
Title
Change in baseline weight at 4 weeks
Description
weight (kg)
Time Frame
Baseline and 4 weeks
Title
Change in baseline waist and hip circumference
Description
waist and hip circumference (cm)
Time Frame
Baseline and 4 weeks
Title
Change in blood pressure from baseline to 4 weeks
Description
Systolic and Diastolic Blood Pressure (mm Hg)
Time Frame
Baseline and 4 weeks
Title
Change in baseline total body fat percentage at 4 weeks
Description
total body fat percentage (%)
Time Frame
Baseline and 4 weeks
Title
Change in fasting and postprandial insulin from baseline to 4 weeks
Description
Insulin (uU/mL)
Time Frame
Baseline and 4 weeks
Title
Change in fasting and postprandial antioxidants from baseline to 4 weeks
Description
Total antioxidant capacity (uM trolox equivalents) measured via Oxygen Radical Absorbance Capacity (ORAC)
Time Frame
Baseline and 4 weeks
Title
Change in fasting and postprandial lipid peroxidation from baseline to 4 weeks
Description
Malondialdehyde (MDA) (uM) measured via Thiobarbituric acid reactive substances (TBARS) assay.
Time Frame
Baseline and 4 weeks
Title
Change in fasting inflammation from baseline to 4 weeks
Description
Interleukin-6 (pg/mL), C-reactive Protein (pg/mL), Tumor Necrosis Factor-α (pg/mL), Plasminogen Activator-1 (pg/mL)
Time Frame
Baseline and 4 weeks
Title
Change in fasting and postprandial glucose and triglycerides from baseline to 4 weeks
Description
Glucose (mg/dL) and triglycerides (mg/dL)
Time Frame
Baseline and 4 weeks
Title
Change in fasting and postprandial peptide YY, cholecystokinin (CCK), and ghrelin from baseline to 4 weeks
Description
Peptide YY (pg/mL), CCK (pg/mL), ghrelin (pg/mL)
Time Frame
Baseline and 4 weeks
Title
Change in fasting and postprandial non-esterified free fatty acids (NEFA) from baseline to 4 weeks
Description
NEFA (mEq/L)
Time Frame
Baseline and 4 weeks
Title
Change in fasting and postprandial hunger and satiety from baseline to 4 weeks
Description
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)
Time Frame
Baseline and 4 weeks
Other Pre-specified Outcome Measures:
Title
Change in fasting and postprandial composite cognitive function from baseline to 4 weeks
Description
NIH tool box- Cognitive Battery (NIHTB-CB) computed- theta score for the sum of all subtests
Time Frame
Baseline and 4 weeks. Measured at fasting, and 30 minutes and 3.5 hours postprandial.
Title
Change in fasting and postprandial Cognitive Battery Motivation from baseline to 4 weeks
Description
Visual Analogue Scale (VAS) (mm). This continuous scale is anchored by either no motivation (0mm) or extremely motivated (100mm).
Time Frame
Baseline and 4 weeks. Measured at fasting, and 30 minutes and 3.5 hours postprandial.
Title
Change in fasting and postprandial NIHTB-CB Flanker Inhibitory Control and Attention Test, and Dimensional Change Card Sort Test from baseline to 4 weeks
Description
NIHTB-CB computed scores ranging from 0-10; high score representing greater accuracy
Time Frame
Baseline and 4 weeks. Measured at fasting, and 30 minutes and 3.5 hours postprandial.
Title
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
Description
NIHTB-CB computed scores representing the number of correctly recalled items; higher scores indicating better memory.
Time Frame
Baseline and 4 weeks. Measured at fasting, and 30 minutes and 3.5 hours postprandial.
Title
Change in Pittsburg Sleep Quality Index scores from baseline to 4 weeks
Description
The scoring is out of 21 points, where a high score indicates poor sleep quality.
Time Frame
Baseline and 4 weeks
Title
Change in State Trait Anxiety Inventory scores from baseline to 4 weeks
Description
The scoring is out of 80 points, where high score indicates higher levels of anxiety.
Time Frame
Baseline and 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
University of Georgia- Department of Foods and Nutrition
City
Athens
State/Province
Georgia
ZIP/Postal Code
30605
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The plan is to share group averages through publication.

Learn more about this trial

The Ability of Pecan Consumption to Improve Vascular Function and Reduce Chronic Disease Risk in Aging Adults

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