Cardiometabolic Effects of Pecans as a Snack

Cardiovascular Diseases Clinical Trial

Official title:

Cardiometabolic Effects of Including Pecans as a Snack to Improve Diet Quality: a Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05071807
• Other study ID #: PKE PECAN
• Status: Completed
• Phase: Phase 2
• Start date: August 15, 2022
• Est. completion date: March 1, 2024

Study information

• Verified date: April 2024
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized, 2-arm, parallel trial will be conducted to examine the effect of pecans on markers of peripheral vascular health, lipids and lipoproteins, blood pressure, and glycemic control.

Description:

A randomized, 2-arm, parallel trial will be conducted to examine the effect of including 2 oz./day of pecans, as a snack, compared to a diet typically consumed by participants intake (devoid of nuts) on markers of peripheral vascular health, lipids and lipoproteins, blood pressure, and glycemic control. Participants will be randomized to pecans or control for 12-weeks. Outcome assessments will be measured at baseline and 12-weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

Inclusion Criteria:

• BMI 25-40 kg/m2

• = 1 criterion for metabolic syndrome (i.e., waist circumference = 94 cm men or = 80 cm women; triglycerides =150 mg/dL; HDL-cholesterol = 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

Exclusion Criteria:

• Current use of tobacco-containing products or (=6 months) cessation

• Allergy/sensitivity/intolerance/dislike of study foods

• Women who are pregnant, lactating, planning to become pregnant or have given birth in the past year

• Individuals who have had a cardiovascular event (heart attack, revascularization, stroke), or have a history of heart failure, liver, kidney, autoimmune diseases or inflammatory conditions such as gastrointestinal disorders or rheumatoid arthritis.

• Type 1 or type 2 diabetes

• Unstable weight =10% body weight for 6 months prior to enrollment

• Systolic Blood pressure >160 mmHg for systolic pressure and/or diastolic blood pressure >/100 mmHg for diastolic pressure at screening

• Fasting blood glucose =126 mg/dL at screening

• Triglycerides =350 mg/dL at screening

• Taking any medications known to affect lipids, blood pressure, or blood glucose levels

• Diagnosed inflammatory conditions or taking prescribed , taking any chronic anti-inflammatory medications (>1 time per week over the past 3 months)

• Use of antibiotics within the prior 8 weeks

• Taking supplements (e.g., psyllium, fish oil, soy lecithin, and phytoestrogens) and botanicals known to affect study outcomes and not willing to cease for the duration of the study

• Individuals consuming >14 alcoholic drinks/week, and not willing to avoid alcohol consumption for 48 hours prior to test visit

• Pre-menopausal women who do not have a regular menstrual cycle of 25-35 days

• PI discretion

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Drug:
• Pecans
Participants will receive 2 oz of pecans daily to replace a typical snack and continue consuming their usual diet for 12 weeks.

Other:
• Usual Care
Participants will receive grocery vouchers and continue consuming their usual diet for 12 weeks.

Locations

Country	Name	City	State
United States	Penn State University	University Park	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Penn State University	American Pecan Council

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in the composition of the gut microbiota	Abundance measured using 16 s rRNA sequencing	12 weeks
Primary	Flow Mediated Dilation	Measured by brachial ultrasound and expressed as percent artery dilation	12 weeks
Secondary	LDL-cholesterol concentration	Assessed from fasting blood draw expressed in mg/dL	12 weeks
Secondary	HDL-cholesterol concentration	Assessed from fasting blood draw expressed in mg/dL	12 weeks
Secondary	Triglycerides	Assessed from fasting blood draw expressed in mg/dL	12 weeks
Secondary	LDL lipoprotein subclasses	Assessed from fasting blood draw expressed in nmol/L	12 weeks
Secondary	HDL lipoprotein subclasses	Assessed from fasting blood draw expressed in umol/L	12 weeks
Secondary	Brachial systolic and diastolic blood pressure	Blood pressure measured assessed using a SphymoCor Ecel (Atcor Medical)	12 weeks
Secondary	Central systolic and diastolic blood pressure	Blood pressure measured assessed using a SphymoCor Ecel (Atcor Medical)	12 weeks
Secondary	Carotid-femoral pulse wave velocity	A measure of arterial stiffness assessed using a SphymoCor Ecel (Atcor Medical). Expressed in meters/second.	12 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.	12 weeks
Secondary	Fasting plasma glucose concentration	Fasting blood glucose assessed by blood draw and expressed in mg/dL	12 weeks
Secondary	Serum insulin concentration	Fasting serum insulin levels assessed by blood draw and expressed in micro IU/m	12 weeks
Secondary	HbA1c	HbA1c assessed in whole blood and expressed in micro IU/mL	12-weeks
Secondary	Diet quality: Healthy Eating Index 2015	Diet quality measured by 24-hour recalls will be assessed using HEI-2015	12-weeks
Secondary	Total Cholesterol concentration	Assessed from fasting blood draw expressed in mg/dL	12-weeks