Pistachio Intake and Nutrition-Related Outcomes in Individuals on GLP-1 Therapy

February 17, 2026 updated by: Ian J. Neeland, MD

Dietary Pistachio Intake and Nutrition-Related Outcomes in Individuals Using GLP-1 Receptor Agonists: A Randomized Controlled Trial

In this study will look at how eating pistachios every day might affect participants weight, how healthy their diet is, and how they feel when eating. Investigators want to see if adding pistachios to meals for 12 weeks helps participants feel fuller, have more energy, and improve body composition. The study will include adults who have been taking GLP-1 medicines like semaglutide or tirzepatide for at least three months. Investigators also want to see if eating pistachios improves overall diet quality and health markers like tiredness and certain levels in blood.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
108

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Individuals with a BMI ≥30 kg/m2 or with a BMI ≥27 kg/m2 with at least one weight-related comorbidity who have been continuously using semaglutide or tirzepatide for three months for a clinical indication and remain on the therapy at the time of enrollment

Exclusion Criteria:

  • No use or contraindication to use of a GLP-1 RA
  • Known allergy to nuts
  • Pregnant or breastfeeding
  • Incarcerated

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Pistachio Group
Participants in this group will eat 2 ounces, or 53 grams of dry-roasted, unsalted pistachios each day along with their regular diet.
Procedure: Dual-energy X-ray absorptiometry (DEXA) scans
DEXA scans will be used to measure body fat
Dietary supplement: Pistachios
Participants will eat 2 ounces, or about 53 grams, of dry-roasted, unsalted pistachios each day along with their regular diet
Active Comparator: No Pistachio Group
Participants in this group will continue eating regular diet without pistachios.
Procedure: Dual-energy X-ray absorptiometry (DEXA) scans
DEXA scans will be used to measure body fat

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change is Satiety as measured by the Hunger and Satiety Visual Analog Scales (VAS)
Time Frame: Baseline, End of study (12 weeks)
Participants will rate their perceived hunger, fullness, and desire to eat on a 100-mm scale, with endpoints ranging from "not at all" to "extremely" for each category.
Baseline, End of study (12 weeks)
Change in fatigue as measured by the Fatigue Severity VAS-F Survey
Time Frame: Baseline, End of study (12 weeks)
Each item is presented on a 100-mm scale, with endpoints labeled to reflect the extremes of the sensation being measured (e.g., "Not at all tired" to "Extremely tired"). Participants will complete the VAS-F at consistent times of the day to minimize variability. Scores will be recorded both before and after meals to capture potential fluctuations in energy levels.
Baseline, End of study (12 weeks)
Change in mood/well-being as measured by the Mental clarity, energy levels, and motivation VAS.
Time Frame: Baseline, End of study (12 weeks)
Each item is presented on a 100-mm scale, with endpoints labeled to reflect the extremes of being measured ranging from, for example, "not at all" to "extremely".
Baseline, End of study (12 weeks)
Change in dietary quality as measured by Healthy Eating Index (HEI)
Time Frame: Baseline, End of study (12 weeks)
HEI scores measure how well a diet aligns with the Dietary Guidelines for Americans. The scores range from 0 to 100, with higher scores indicating foods align with key dietary recommendations and dietary patterns published in the Dietary Guidelines.
Baseline, End of study (12 weeks)
Change in fasting glucose as measured by medical record review
Time Frame: Baseline, End of study (12 weeks)
Baseline, End of study (12 weeks)
Change in HbA1c as measured by medical record review
Time Frame: Baseline, End of study (12 weeks)
Baseline, End of study (12 weeks)
Change in total cholesterol as measured by medical record review
Time Frame: Baseline, End of study (12 weeks)
Baseline, End of study (12 weeks)
Change in LDL-C as measured by medical record review
Time Frame: Baseline, End of study (12 weeks)
Baseline, End of study (12 weeks)
Change in HDL-C as measured by medical record review
Time Frame: Baseline, End of study (12 weeks)
Baseline, End of study (12 weeks)
Change in triglycerides as measured by medical record review
Time Frame: Baseline, End of study (12 weeks)
Baseline, End of study (12 weeks)
Change in food enjoyment as measured by the Food Pleasure Scale (FPS)
Time Frame: Baseline, End of study (12 weeks)
The FPS is a validated 21-item tool designed to measure multiple dimensions of food-related enjoyment, including sensory characteristics (appearance, odor, taste, texture), expectations and desires (memories, habits, expectations, choices, needs), and other relevant factors. The importance of each item in relation to general pleasurable experiences of food is rated on a 5-point ordinal scale ranging from 1 ("Not important at all") to 5 ("Extremely important").
Baseline, End of study (12 weeks)
Change in physical activity as measured by International Physical Activity Questionnaire (IPAQ)
Time Frame: Baseline, End of study (12 weeks)
The IPAQ short form consists of 7 questions designed to assess physical activity levels over the past 7 days in adults. The score is calculated using published guidelines and ranges from 0 to infinity and measures physical activity in median median MET-minutes/week. This is a continuous measure and is calculated as: Total MET-min/week = (Walk METs*min*days) + (Moderate activity METs*min*days) + Vigorous activity METs*min*days).
Baseline, End of study (12 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change in body weight as measured by medical record review
Time Frame: Baseline, End of study (12 weeks)
Baseline, End of study (12 weeks)
Change in waist circumference as measured by medical record review
Time Frame: Baseline, End of study (12 weeks)
Baseline, End of study (12 weeks)
Change in hip circumference as measured by medical record review
Time Frame: Baseline, End of study (12 weeks)
Baseline, End of study (12 weeks)
Change in fat mass as measured by DEXA scan
Time Frame: Baseline, End of study (12 weeks)
Baseline, End of study (12 weeks)
Change in lean body mass as measured by DEXA scan
Time Frame: Baseline, End of study (12 weeks)
Baseline, End of study (12 weeks)
Change in overall body fat percentage as measured by DEXA scan
Time Frame: Baseline, End of study (12 weeks)
Baseline, End of study (12 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ian J. Neeland, MD

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ian Neeland, MD, University Hospitals Cleveland Medical Center
  • Principal Investigator: Abigail Raffner, MD, University Hospitals Cleveland Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 29, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 24, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY20250409

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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