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

NCT ID: NCT07244445

Last Updated: 2026-02-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-29
• Study Completion Date: 2027-12-31

Brief Summary

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.

Conditions

Dietary Change; Obesity & Overweight; Food Acceptance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Pistachios

Intervention Type: DIETARY_SUPPLEMENT

Participants will eat 2 ounces, or about 53 grams, of dry-roasted, unsalted pistachios each day along with their regular diet

Dual-energy X-ray absorptiometry (DEXA) scans

Intervention Type: PROCEDURE

DEXA scans will be used to measure body fat

No Pistachio Group

Participants in this group will continue eating regular diet without pistachios.

Group Type: ACTIVE_COMPARATOR

Dual-energy X-ray absorptiometry (DEXA) scans

Intervention Type: PROCEDURE

DEXA scans will be used to measure body fat

Interventions

Pistachios

Participants will eat 2 ounces, or about 53 grams, of dry-roasted, unsalted pistachios each day along with their regular diet

Intervention Type: DIETARY_SUPPLEMENT

Dual-energy X-ray absorptiometry (DEXA) scans

DEXA scans will be used to measure body fat

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ian J. Neeland, MD

OTHER

Sponsor Role: lead

Responsible Party

Ian J. Neeland, MD

Director, UH Center for Cardiovascular Prevention

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ian Neeland, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Abigail Raffner, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

University Hospitals Cleveland Medical Center

Clevland, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ian Neeland, MD

Role: CONTACT

Ian.Neeland@UHhospitals.org

216-844-5965

Abigail Raffner, PhD, RD, LD

Role: CONTACT

Abigail.Raffner@UHhospitals.org

216-368-0756

Facility Contacts

Ian Neeland, MD

Role: primary

Ian.Neeland@UHhospitals.org

216-844-5965

Abigail Raffner, PhD, RD, LD

Role: backup

Abigail.Raffner@UHhospitals.org

216-368-0756

Other Identifiers

STUDY20250409

Identifier Type: -

Identifier Source: org_study_id