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

NCT04385537 | Completed

• 1 other identifier: PROJECT00001978
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging

Outcome Measures

Primary Outcomes (5)

• Change in fasting and postprandial Flow-Mediated Dilation from baseline to 4 weeks

  Flow-Mediated Dilation %

  Baseline and 4 weeks

• Change in fasting and postprandial vessel diameter from baseline to 4 weeks

  baseline diameter (mm) and peak dilation (mm)

  Baseline and 4 weeks

• Change in fasting and postprandial reactive hyperemia velocity from baseline to 4 weeks

  Baseline velocity (cm/s) and reactive hyperemia velocity (cm/s)

  Baseline and 4 weeks

• Change in fasting and postprandial shear rate from baseline to 4 weeks

  baseline shear rate (sec.-1) and reactive hyperemia shear rate (sec.-1)

  Baseline and 4 weeks

• 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)

  Baseline and 4 weeks

Secondary Outcomes (13)

• Change in fasting blood lipids from baseline to 4 weeks

  Baseline and 4 weeks

• Change in baseline weight at 4 weeks

  Baseline and 4 weeks

• Change in baseline waist and hip circumference

  Baseline and 4 weeks

• Change in blood pressure from baseline to 4 weeks

  Baseline and 4 weeks

• Change in baseline total body fat percentage at 4 weeks

  Baseline and 4 weeks

Other Outcomes (6)

• Change in fasting and postprandial composite cognitive function from baseline to 4 weeks

  Baseline and 4 weeks. Measured at fasting, and 30 minutes and 3.5 hours postprandial.

• Change in fasting and postprandial Cognitive Battery Motivation from baseline to 4 weeks

  Baseline and 4 weeks. Measured at fasting, and 30 minutes and 3.5 hours postprandial.

• Change in fasting and postprandial NIHTB-CB Flanker Inhibitory Control and Attention Test, and Dimensional Change Card Sort Test from baseline to 4 weeks

  Baseline and 4 weeks. Measured at fasting, and 30 minutes and 3.5 hours postprandial.

Study Arms (2)

Control

NO INTERVENTION

Participants in this group avoid all nuts for 4-weeks

PECAN

EXPERIMENTAL

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

Dietary Supplement: PECAN

Interventions

PECAN DIETARY_SUPPLEMENT

Raw pecan halves without other changes to their habitual diet.

PECAN

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Georgia: lead
• American Pecan Council: collaborator

Study Sites (1)

University of Georgia- Department of Foods and Nutrition

Athens, Georgia, 30605, United States

Location

Related Publications (3)

• Cogan B, Pearson RC, Jenkins NT, Paton CM, Cooper JA. A 4-Week Pecan-Enriched Diet Improves Postprandial Lipid Peroxidation in Aging Adults. J Med Food. 2023 Sep;26(9):654-662. doi: 10.1089/jmf.2023.0036. Epub 2023 Aug 28.

  PMID: 37638838 DERIVED

• Cogan B, Pearson RC, Jenkins NT, Paton CM, Cooper JA. A pecan-enriched diet reduced postprandial appetite intensity and enhanced peptide YY secretion: A randomized control trial. Clin Nutr ESPEN. 2023 Aug;56:25-35. doi: 10.1016/j.clnesp.2023.05.002. Epub 2023 May 8.

  PMID: 37344080 DERIVED

• Cogan B, Pearson RC, Paton CM, Jenkins NT, Cooper JA. Pecan-enriched diet improves cholesterol profiles and enhances postprandial microvascular reactivity in older adults. Nutr Res. 2023 Mar;111:44-58. doi: 10.1016/j.nutres.2023.01.001. Epub 2023 Jan 31.

  PMID: 36822079 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Dept. of Foods and Nutrition

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: May 13, 2020
• Study Start: September 17, 2020
• Primary Completion: April 16, 2022
• Study Completion: April 16, 2022
• Last Updated: May 24, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)