NCT04056208

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for phase_2 type-2-diabetes

Timeline
Completed

Started Sep 2019

Longer than P75 for phase_2 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 14, 2019

Completed
26 days until next milestone

Study Start

First participant enrolled

September 9, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2022

Completed
Last Updated

August 18, 2023

Status Verified

August 1, 2023

Enrollment Period

3.2 years

First QC Date

August 12, 2019

Last Update Submit

August 15, 2023

Conditions

Type 2 DiabetesCardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

  • Fasting plasma glucose concentration

    Fasting blood glucose (mg/dL)

    12 weeks

Secondary Outcomes (15)

  • HbA1c

    12 weeks

  • Serum insulin concentration (mIU/L)

    12 weeks

  • Peripheral systolic and diastolic blood pressure (mm Hg)

    12 weeks

  • Central systolic and diastolic blood pressure (mm Hg)

    12 weeks

  • Carotid-femoral pulse wave velocity (m/s)

    12 weeks

  • +10 more secondary outcomes

Study Arms (2)

Evening Pistachio Consumption

ACTIVE COMPARATOR

Participants will consume two ounces per day (57 g) of pistachios as an evening snack (i.e., after dinner and before sleep).

Drug: Pistachio

Usual care

ACTIVE COMPARATOR

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

Interventions

PistachioDRUG

Unsalted pistachios

Evening Pistachio Consumption
Usual careOTHER

Advice and resources will be provided

Usual care

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Location

Related Publications (2)

  • Riley TM, Wright J, Lamendella R, Bisanz JE, Chen See J, Kanani K, Kris-Etherton PM, Petersen KS. Nighttime Pistachio Consumption Alters Stool Microbiota Diversity and Taxa Abundance Compared with Education to Consume 1-2 Carbohydrate Exchanges (15-30 grams) over 12 Weeks in Adults with Prediabetes: A Secondary Analysis from a Randomized Crossover Trial. Curr Dev Nutr. 2025 May 27;9(7):107481. doi: 10.1016/j.cdnut.2025.107481. eCollection 2025 Jul.

    PMID: 40612050DERIVED

  • Riley TM, Kris-Etherton PM, Hart TL, Petersen KS. Intake of Pistachios as a Nighttime Snack Has Similar Effects on Short- and Longer-Term Glycemic Control Compared with Education to Consume 1-2 Carbohydrate Exchanges in Adults with Prediabetes: A 12-Wk Randomized Crossover Trial. J Nutr. 2024 Apr;154(4):1219-1231. doi: 10.1016/j.tjnut.2024.01.021. Epub 2024 Jan 24.

    PMID: 38278217DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Crossover assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2019

First Posted

August 14, 2019

Study Start

September 9, 2019

Primary Completion

November 17, 2022

Study Completion

November 17, 2022

Last Updated

August 18, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)