Diet Quality, Pecans, and Cardiometabolic Health

NCT04487808 | Withdrawn Phase 2

• 1 other identifier: Pecan
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• Flow mediated dilation

  Measured by brachial ultrasound and expressed as percent artery dilation

  4 weeks

Secondary Outcomes (11)

• LDL-cholesterol concentration

  4 weeks

• HDL-cholesterol concentrations

  4 weeks

• Triglycerides

  4 weeks

• LDL lipoprotein subclasses

  4 weeks

• HDL lipoprotein subclasses

  4 weeks

Other Outcomes (1)

• Change in the composition of the gut microbiota

  4 weeks

Study Arms (3)

Average American Diet

ACTIVE COMPARATOR

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

Average American Diet + Pecans

ACTIVE COMPARATOR

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

Healthy Diet + Pecans

ACTIVE COMPARATOR

High diet quality, measured by Healthy Index-2015 score \>95, and includes 2 oz./day of pecans.

Drug: Pecan

Interventions

Pecan DRUG

Unsalted raw pecans incorporated in snack and meal recipes as part of a dietary pattern

Average American Diet + Pecans; Healthy Diet + Pecans

Average American Diet devoid of nuts OTHER

Diet mimicking usual American intake

Average American Diet

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Penn State University: lead

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: July 27, 2020
• Study Start: May 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: August 18, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share