Pistachios Blood Sugar Control, Heart and Gut Health

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04056208
• Other study ID #: PKE Pistachio
• Status: Completed
• Phase: Phase 2
• Start date: September 9, 2019
• Est. completion date: November 17, 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: November 17, 2022
• Est. primary completion date: November 17, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Type 2 Diabetes

Intervention

Drug:
• Pistachio
Unsalted pistachios

Other:
• Usual care
Advice and resources will be provided

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Penn State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting plasma glucose concentration	Fasting blood glucose (mg/dL)	12 weeks
Secondary	HbA1c	HbA1c (%) will be assessed at the beginning and end of each treatment period	12 weeks
Secondary	Serum insulin concentration (mIU/L)	fasting serum insulin levels assessed by blood draw	12 weeks
Secondary	Peripheral systolic and diastolic blood pressure (mm Hg)	Blood pressure measured assessed using a SphymoCor Xcel (Atcor Medical).	12 weeks
Secondary	Central systolic and diastolic blood pressure (mm Hg)	Blood pressure measured assessed using a SphymoCor Xcel (Atcor Medical).	12 weeks
Secondary	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
Secondary	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
Secondary	LDL cholesterol concentration (mg/dL)	Assessed using fasting blood draw	12 weeks
Secondary	HDL cholesterol concentration	Assessed using fasting blood draw	12 weeks
Secondary	Total cholesterol concentration	Assessed using fasting blood draw	12 weeks
Secondary	Triglyceride concentration	Assessed using fasting blood draw	12 weeks
Secondary	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
Secondary	waist circumference (cm)	Measured 10 cm above the navel	12 weeks
Secondary	body weight (lbs)	Assessed using calibrated scale in Clinical Research Center	12 weeks
Secondary	Diet quality: Healthy Eating Index 2015	Assessed using the Healthy Eating Index 2015	12 weeks
Secondary	Change in the composition of the gut microbiome	microbiome composition assessed using fecal collection kit	12 weeks