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Diet Quality, Pecans, and Cardiometabolic Health

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ClinicalTrials.gov Identifier: NCT04487808
Recruitment Status : Withdrawn (The study did not enroll any subjects. It was never started because of the Covid pandemic.)
First Posted : July 27, 2020
Last Update Posted : June 14, 2021
Sponsor:
Information provided by (Responsible Party):
Penny, Penn State University

Brief Summary:
A three-period, randomized, crossover controlled feeding trial will be conducted to examine the effect of including 2 oz./day of pecans, as a snack, in a diet representative of average American intake, compared to a diet representative of average American intake devoid of nuts, and a healthy dietary pattern including 2 oz./day of pecans on markers of peripheral vascular health, lipids and lipoproteins, blood pressure, and glycemic control.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Drug: Pecan Other: Average American Diet devoid of nuts Phase 2

Detailed Description:
Participants will be randomized to each diet for 4-weeks with a minimum 2-week break between the diet periods. All caloric foods and beverages will be provided. Outcome assessments will be done at baseline and the end of each diet period.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Cardiometabolic Effects of Including Pecans as a Snack in Dietary Patterns That Vary in Diet Quality: a Randomized, Controlled Feeding, Crossover Study
Estimated Study Start Date : May 1, 2021
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Average American Diet
Diet representative of average American intake in terms of diet quality measured by the Healthy Eating Index-2015.
Other: Average American Diet devoid of nuts
Diet mimicking usual American intake

Active Comparator: Average American Diet + Pecans
Diet that approximates average American intake in terms of diet quality measured by the Healthy Eating Index-2015, but includes 2 oz./day of pecans.
Drug: Pecan
Unsalted raw pecans incorporated in snack and meal recipes as part of a dietary pattern

Active Comparator: Healthy Diet + Pecans
High diet quality, measured by Healthy Index-2015 score >95, and includes 2 oz./day of pecans.
Drug: Pecan
Unsalted raw pecans incorporated in snack and meal recipes as part of a dietary pattern




Primary Outcome Measures :
  1. Flow mediated dilation [ Time Frame: 4 weeks ]
    Measured by brachial ultrasound and expressed as percent artery dilation


Secondary Outcome Measures :
  1. LDL-cholesterol concentration [ Time Frame: 4 weeks ]
    Assessed from fasting blood draw expressed in mg/dL

  2. HDL-cholesterol concentrations [ Time Frame: 4 weeks ]
    Assessed from fasting blood draw expressed in mg/dL

  3. Triglycerides [ Time Frame: 4 weeks ]
    Assessed from fasting blood draw expressed in mg/dL

  4. LDL lipoprotein subclasses [ Time Frame: 4 weeks ]
    Assessed from fasting blood draw expressed in nmol/L

  5. HDL lipoprotein subclasses [ Time Frame: 4 weeks ]
    Assessed from fasting blood draw expressed in umol/L

  6. Peripheral systolic and diastolic blood pressure [ Time Frame: 4 weeks ]
    Blood pressure measured assessed using a SphymoCor Ecel (Atcor Medical)

  7. Central systolic and diastolic blood pressure [ Time Frame: 4 weeks ]
    Blood pressure measured assessed using a SphymoCor Ecel (Atcor Medical).

  8. Carotid-femoral pulse wave velocity [ Time Frame: 4 weeks ]
    A measure of arterial stiffness assessed using a SphymoCor Ecel (Atcor Medical). Expressed in meters/second.

  9. Augmentation Index [ Time Frame: 4 weeks ]
    A measure of arterial stiffness assessed using a SphymoCor Ecel (Atcor Medical). Expressed as a percentage. A higher percentage value is indicative of greater arterial stiffness.

  10. Fasting plasma glucose concentration [ Time Frame: 4 weeks ]
    Fasting blood glucose assessed by blood draw and expressed in mg/dL

  11. Serum insulin concentration [ Time Frame: 4 weeks ]
    Fasting serum insulin levels assessed by blood draw and expressed in micro IU/mL


Other Outcome Measures:
  1. Change in the composition of the gut microbiota [ Time Frame: 4 weeks ]
    Abundance measured using 16 s rRNA sequencing



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI ≥25 and ≤40 kg/m2
  • ≥ 1 criterion for metabolic syndrome (i.e. waist circumference ≥ 94 cm men or ≥80 cm women; triglycerides ≥150 mg/dL; HDL ≤ 40 mg/dL men or ≤50 mg/dL women; systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥85 mmHg; fasting plasma glucose ≥100 mg/dL) at screening.
  • non-smoking

Exclusion Criteria:

  • Current tobacco use or use within the previous 6 months
  • Diagnosed diabetes or fasting glucose levels > 126 mg/dL at screening
  • Systolic blood pressure >160 mm Hg or diastolic blood pressure > 100 mm Hg at screening.
  • Use of anti-hypertensive, lipid lowering, glucose lowering drugs, steroids, or antibiotics in the previous month
  • History of a cardiovascular event (heart attack, revascularization, stroke), or heart failure, liver, kidney, autoimmune diseases or inflammatory conditions such as gastrointestinal disorders or rheumatoid arthritis
  • Use of supplements and botanicals known to affect study outcomes (e.g. psyllium, fish oil, soy lecithin, and phytoestrogens) and not willing to cease for the duration of the study
  • Pregnancy, lactation or planning to become pregnant
  • Consumption of >14 alcoholic drinks/week
  • Intolerance/allergy/sensitivity to foods included in the study menus
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Responsible Party: Penny, Distinguished Professor of Nutrition, Penn State University
ClinicalTrials.gov Identifier: NCT04487808    
Other Study ID Numbers: Pecan
First Posted: July 27, 2020    Key Record Dates
Last Update Posted: June 14, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiovascular Diseases