Diet Quality, Pecans, and Cardiometabolic Health

Cardiovascular Diseases Clinical Trial

Official title:

Cardiometabolic Effects of Including Pecans as a Snack in Dietary Patterns That Vary in Diet Quality: a Randomized, Controlled Feeding, Crossover Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04487808
• Other study ID #: Pecan
• Status: Withdrawn
• Phase: Phase 2
• Start date: May 1, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: August 2023
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Drug:
• Pecan
Unsalted raw pecans incorporated in snack and meal recipes as part of a dietary pattern

Other:
• Average American Diet devoid of nuts
Diet mimicking usual American intake

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Penn State University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in the composition of the gut microbiota	Abundance measured using 16 s rRNA sequencing	4 weeks
Primary	Flow mediated dilation	Measured by brachial ultrasound and expressed as percent artery dilation	4 weeks
Secondary	LDL-cholesterol concentration	Assessed from fasting blood draw expressed in mg/dL	4 weeks
Secondary	HDL-cholesterol concentrations	Assessed from fasting blood draw expressed in mg/dL	4 weeks
Secondary	Triglycerides	Assessed from fasting blood draw expressed in mg/dL	4 weeks
Secondary	LDL lipoprotein subclasses	Assessed from fasting blood draw expressed in nmol/L	4 weeks
Secondary	HDL lipoprotein subclasses	Assessed from fasting blood draw expressed in umol/L	4 weeks
Secondary	Peripheral systolic and diastolic blood pressure	Blood pressure measured assessed using a SphymoCor Ecel (Atcor Medical)	4 weeks
Secondary	Central systolic and diastolic blood pressure	Blood pressure measured assessed using a SphymoCor Ecel (Atcor Medical).	4 weeks
Secondary	Carotid-femoral pulse wave velocity	A measure of arterial stiffness assessed using a SphymoCor Ecel (Atcor Medical). Expressed in meters/second.	4 weeks
Secondary	Augmentation Index	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.	4 weeks
Secondary	Fasting plasma glucose concentration	Fasting blood glucose assessed by blood draw and expressed in mg/dL	4 weeks
Secondary	Serum insulin concentration	Fasting serum insulin levels assessed by blood draw and expressed in micro IU/mL	4 weeks