Cardiometabolic Effects of Pecans as a Snack

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-15

Study Completion Date

2024-03-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Pecan Group

Participants will consume their usual diet, but replace one snack with unsalted raw pecans incorporated as a snack

Group Type ACTIVE_COMPARATOR

Pecans

Intervention Type DRUG

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

Usual Care Group

Participants will consume their usual diet devoid of nuts

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type OTHER

Participants will receive grocery vouchers and continue consuming their usual diet for 12 weeks.

Interventions

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Pecans

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

Intervention Type DRUG

Usual Care

Participants will receive grocery vouchers and continue consuming their usual diet for 12 weeks.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes