Pistachios Blood Sugar Control, Heart and Gut Health

The Effect of Pistachios on Risk Factors for Cardiometabolic Disease in Individuals With Pre-diabetes: a Randomized, Cross-over Study

A two-period randomized crossover study will be conducted to evaluate the effect of nighttime pistachio consumption (i.e., after dinner and before sleep) on fasting blood sugar levels, longer-term blood sugar control, and risk factors for heart disease. This study will also investigate how pistachios affects gut health.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Type 2 Diabetes
• Intervention / Treatment: Drug: Pistachio; Other: Usual care

Detailed Description

A two-period randomized crossover trial will be conducted. Participants will be randomized to receive each treatment for 12 weeks followed by a minimum 4-week wash-out period. During the pistachio treatment, participants will consume two ounces per day (57 g) of pistachios as an evening snack. During the control phase subjects will be given advice to consume 1-2 exchanges of carbohydrate as an evening snack, which is consistent with usual care. Markers of glycemic control, cardiovascular risk factors and gut health will be assessed at the beginning and the end of each treatment period.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • University Park, Pennsylvania, United States, 16802
      • Pennsylvania State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• BMI ≥25 and ≤45 kg/m2
• Fasting plasma glucose 100 - 125 mg/dL
• non-Smoking

Exclusion Criteria:

• Diagnosed diabetes or fasting glucose >126 mg/dl
• Systolic blood pressure >160mmHg or diastolic blood pressure >100mmHg)
• Prescribed anti-hypertensive, lipid lowering or glucose lowering drugs
• Established cardiovascular disease, stroke, diabetes, liver, kidney or autoimmune disease or inflammatory conditions
• Use of supplements (psyllium, fish oil, soy lecithin, phytoestrogens) and botanicals and not willing to cease for the duration of the study
• Women who are pregnant, lactating, planning to become pregnant or have given birth in the past year
• Weight loss of >=10% of body weight within the 6 months prior to enrolling in the study
• Smoking or use of any tobacco products
• Allergy/intolerance/sensitive to pistachios
• Consumption of >14 alcoholic drinks/week
• Shift-workers and those who cannot consume a snack in the evening

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Evening Pistachio Consumption; Participants will consume two ounces per day (57 g) of pistachios as an evening snack (i.e., after dinner and before sleep).	Drug: Pistachio; Unsalted pistachios
Active Comparator: Usual care; Advice to consume a snack that contains 1-2 exchanges (15-30 g of carbohydrate) as an evening snack - this is consistent with the current standard of care for people with impaired fasting glucose.	Other: Usual care; Advice and resources will be provided

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting plasma glucose concentration	Fasting blood glucose (mg/dL)	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	HbA1c (%) will be assessed at the beginning and end of each treatment period	12 weeks
Serum insulin concentration (mIU/L)	fasting serum insulin levels assessed by blood draw	12 weeks
Peripheral systolic and diastolic blood pressure (mm Hg)	Blood pressure measured assessed using a SphymoCor Xcel (Atcor Medical).	12 weeks
Central systolic and diastolic blood pressure (mm Hg)	Blood pressure measured assessed using a SphymoCor Xcel (Atcor Medical).	12 weeks
Carotid-femoral pulse wave velocity (m/s)	A measure of arterial stiffness assessed using a SphymoCor Xcel (Atcor Medical). A higher percentage value is indicative of greater arterial stiffness.	12 weeks
Augmentation Index (%)	A measure of arterial stiffness assessed using a SphymoCor Xcel (Atcor Medical). A higher percentage value is indicative of greater arterial stiffness.	12 weeks
LDL cholesterol concentration (mg/dL)	Assessed using fasting blood draw	12 weeks
HDL cholesterol concentration	Assessed using fasting blood draw	12 weeks
Total cholesterol concentration	Assessed using fasting blood draw	12 weeks
Triglyceride concentration	Assessed using fasting blood draw	12 weeks
HOMA-IR	Assessed using fasting blood draw and standardized HOMA-IR calculation. Fasting plasma glucose multiplied by fasting plasma insulin divided by 405.	12 weeks
waist circumference (cm)	Measured 10 cm above the navel	12 weeks
body weight (lbs)	Assessed using calibrated scale in Clinical Research Center	12 weeks
Diet quality: Healthy Eating Index 2015	Assessed using the Healthy Eating Index 2015	12 weeks
Change in the composition of the gut microbiome	microbiome composition assessed using fecal collection kit	12 weeks

Collaborators and Investigators

• Sponsor: Penn State University

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2019
• Primary Completion (Actual): November 17, 2022
• Study Completion (Actual): November 17, 2022

Study Registration Dates

• First Submitted: August 12, 2019
• First Submitted That Met QC Criteria: August 13, 2019
• First Posted (Actual): August 14, 2019

Study Record Updates

• Last Update Posted (Actual): August 18, 2023
• Last Update Submitted That Met QC Criteria: August 15, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: PKE Pistachio

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No