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

NCT07244445 | Recruiting DMC

• 1 other identifier: STUDY20250409
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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

Keywords

Dietary quality; Eating enjoyment; Satiety; Weight-related outcomes

Outcome Measures

Primary Outcomes (12)

• Change is Satiety as measured by the Hunger and Satiety Visual Analog Scales (VAS)

  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

  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.

  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)

  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 food enjoyment as measured by the Food Pleasure Scale (FPS)

  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 fasting glucose as measured by medical record review

  Baseline, End of study (12 weeks)

• Change in HbA1c as measured by medical record review

  Baseline, End of study (12 weeks)

• Change in total cholesterol as measured by medical record review

  Baseline, End of study (12 weeks)

• Change in LDL-C as measured by medical record review

  Baseline, End of study (12 weeks)

• Change in HDL-C as measured by medical record review

  Baseline, End of study (12 weeks)

• Change in triglycerides as measured by medical record review

  Baseline, End of study (12 weeks)

• Change in physical activity as measured by International Physical Activity Questionnaire (IPAQ)

  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 Outcomes (6)

• Change in body weight as measured by medical record review

  Baseline, End of study (12 weeks)

• Change in waist circumference as measured by medical record review

  Baseline, End of study (12 weeks)

• Change in hip circumference as measured by medical record review

  Baseline, End of study (12 weeks)

• Change in fat mass as measured by DEXA scan

  Baseline, End of study (12 weeks)

• Change in lean body mass as measured by DEXA scan

  Baseline, End of study (12 weeks)

Study Arms (2)

Pistachio Group

EXPERIMENTAL

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

Dietary Supplement: Pistachios; Procedure: Dual-energy X-ray absorptiometry (DEXA) scans

No Pistachio Group

ACTIVE COMPARATOR

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

Procedure: Dual-energy X-ray absorptiometry (DEXA) scans

Interventions

Pistachios DIETARY_SUPPLEMENT

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

Pistachio Group

Dual-energy X-ray absorptiometry (DEXA) scans PROCEDURE

DEXA scans will be used to measure body fat

No Pistachio Group; Pistachio Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ian J. Neeland, MD: lead

Study Sites (1)

University Hospitals Cleveland Medical Center

Clevland, Ohio, 44106, United States

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight

Interventions

Absorptiometry, Photon

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Ian Neeland, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

• Abigail Raffner, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ian Neeland, MD

CONTACT

216-844-5965; Ian.Neeland@UHhospitals.org

Abigail Raffner, PhD, RD, LD

CONTACT

216-368-0756; Abigail.Raffner@UHhospitals.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, UH Center for Cardiovascular Prevention

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start: January 29, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)