Clinical trial NCT05071807: Cardiometabolic Effects of Pecans as a Snack
Official title: Cardiometabolic Effects of Including Pecans as a Snack to Improve Diet Quality: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cardiovascular Diseases
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: American Pecan Council
First posted: 2021-10-08
Enrollment: 138
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Flow Mediated Dilation
timeFrame: 12 weeks
Secondary outcomes:
measure: LDL-cholesterol Concentration
timeFrame: 12 weeks
measure: HDL-cholesterol Concentration
timeFrame: 12 weeks
measure: Triglycerides
timeFrame: 12 weeks
measure: LDL Lipoprotein Subclasses
timeFrame: 12 weeks
measure: HDL Lipoprotein Subclasses
timeFrame: 12 weeks
measure: Brachial Systolic and Diastolic Blood Pressure
timeFrame: 12 weeks
measure: Central Systolic and Diastolic Blood Pressure
timeFrame: 12 weeks
measure: Carotid-femoral Pulse Wave Velocity
timeFrame: 12 weeks
measure: Augmentation Index@75bpm
timeFrame: 12 weeks
measure: Fasting Plasma Glucose Concentration
timeFrame: 12 weeks
measure: Serum Insulin Concentration
timeFrame: 12 weeks
measure: HbA1c
timeFrame: 12-weeks
measure: Diet Quality: Healthy Eating Index 2020
timeFrame: 12-weeks
measure: Total Cholesterol Concentration
timeFrame: 12-weeks
measure: LDL Subclasses
timeFrame: 12 weeks
measure: HDL Subclass-Large
timeFrame: 12 weeks
Other outcomes:
measure: Change in the Composition of the Gut Microbiota
timeFrame: 12 weeks
Locations:
city: University Park
country: United States
facility: Penn State University
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Kristina Petersen, PhD
role: PRINCIPAL_INVESTIGATOR
References: